New device for strokes due to PFO

Details on the latest recalls, warnings, and approvals


Recalls

A class I recall of 105 HeartWare ventricular assist device pumps because of a design problem with the driveline connector, which could become contaminated and cause electrical issues or pump stops, potentially leading to death or other serious adverse events. Affected products were manufactured between March 17, 2006, and June 27, 2016. The manufacturer is also recalling 4,564 device controllers because of the potential for loose power connectors, which could lead to corrosion, electrical problems, reduced speaker volume, or connection failures. Recalled devices were manufactured between March 6, 2006, and Oct. 17, 2016.

Photo by Thinkstock
Photo by Thinkstock

A class I recall of the Willy Rusch Tracheostomy Tube Set because of possible disconnection during use on a ventilated patient. Should the connector detach from the tracheostomy tube shaft during use, it could deprive the patient of adequate ventilation, requiring immediate medical intervention and tube replacement. The recalled devices were manufactured between June and December 2015.

A recall of Medtronic neurovascular products because of potential separation and detachment of their polytetrafluoroethylene coating. Recalled products include certain lots of the Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and Ultraflow and Marathon flow directed microcatheters. If the coating were to separate, particulate matter could enter the bloodstream, potentially leading to a thromboembolic event. The 84,278 units potentially affected by the recall were manufactured from July 2014 to September 2016 and distributed worldwide.

A recall of some sterile drug products produced by Cantrell Drug Company due to lack of sterility assurance. Recalled products include certain lots of drugs for injection (e.g., heparin, lidocaine) distributed nationwide from May 25 to Oct. 31, 2016.

A class I recall of 98 FindrWIRZ guidewire system devices because of potential coating separation. This separation may be caused by issues with the devices' design or manufacturing processes. The recall includes certain product lots distributed between June 1 and Sept. 26, 2016.

A class I recall of Leonhard Lang defibrillation electrodes due to a connector compatibility issue with the Welch Allyn AED model 10. The recall applies to 8,040 devices distributed nationwide between Feb. 14, 2014, and Aug. 3, 2016.

A recall of all sterile products by Wells Pharmacy Network due to FDA concerns about a lack of sterility assurance. Recalled products were prepared between Feb. 22 and Sept. 14, 2016, and remain within expiry. No portion of any of these medications has been found to be nonsterile.

Approvals

The Amplatzer PFO Occluder device to prevent recurrent strokes in certain patients. The device reduces the risk of stroke in patients who had a previous stroke believed to be caused by a blood clot that passed through a patent foramen ovale and then traveled to the brain. A randomized study of 499 patients found a 50% reduction in the rate of new strokes in those treated with the device plus blood-thinning medications compared to those taking blood-thinning medications alone. Adverse effects associated with the device or the implantation procedure include injury to the heart, atrial fibrillation, bleeding, stroke, and blood clots in the heart, leg, or lung.

Olaratumab (Lartruvo) with doxorubicin to treat certain adults with soft-tissue sarcoma. It is approved for patients who cannot be cured with radiation or surgery and have a type of soft-tissue sarcoma for which an anthracycline is an appropriate treatment. In a randomized clinical trial of 133 patients, those who received the drug with doxorubicin had a median survival time of 26.5 months, compared to 14.7 months for those who received only doxorubicin. Common side effects include nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. Serious risks include infusion-related reactions (e.g., low blood pressure, fever, rash) and embryo-fetal harm. The drug was approved through the FDA's fast-track process and is considered an orphan drug.

Prasterone (Intrarosa) to treat postmenopausal women experiencing moderate to severe dyspareunia due to vulvar and vaginal atrophy. The once-daily vaginal insert is the first FDA-approved product to contain prasterone (aka dehydroepiandrosterone). In two 12-week trials of 406 postmenopausal women ages 40 to 80 who reported dyspareunia, those who received the drug experienced reduced severity of pain during sex than those who received a placebo vaginal insert. In safety trials, the most common adverse reactions were vaginal discharge and abnormal Pap smear.

Miscellaneous

A letter to clinicians concerning multiple reports of adverse events associated with the Vascu-Guard peripheral vascular patch during carotid endarterectomy. The reports from 2016 include intraoperative or postoperative bleeding and hematomas, complications that have required additional clinical interventions and that may be related to three patient deaths that occurred shortly after surgery. The FDA is investigating these adverse events and recommends that clinicians discuss the risks and benefits of all available treatment options with their patients.