Medtronic Warns of Vascular Trauma, Some Resulting in Death, With CoreValve’s EnVeo R Delivery Catheter
Medtronic is warning physicians to exercise caution when using the EnVeo R catheter system to deliver the CoreValve Evolut R transcatheter aortic valve. The move comes after an internal analysis conducted by the company revealed a number of patient deaths caused by damage to the vasculature.
In a “Dear Doctor” letter, Medtronic says that, to date, there have been 39 reports of vascular trauma, including 19 patient deaths. Based on the number of units distributed as of May 2016, the company notes that the events are infrequent, with trauma occurring in 0.136% of patients and death in 0.078% of patients.
Given the potential severity of vascular trauma, Medtronic has voluntarily updated the EnVeo R delivery catheter’s Instructions For Use (IFU), making several recommendations to physicians. For example, “if significant resistance is encountered during advancement of the delivery system, do not force passage,” the letter states. “Use increased fluoroscopic magnification to assess the vasculature.”
Medtronic’s letter, which is available here, also recommends physicians consider patient anatomy, paying particular consideration to complex configurations. They highlight several complex anatomic features, including tight curvature of the aortic arch and significant calcification in the aortic arch, that might increase the risk for trauma.
In a statement to TCTMD, Medtronic said their internal investigation identified no quality issues with the delivery catheter and they are not recalling any product. “In addition, we have updated the customer training program to include the recommendations,” reported Medtronic spokesperson Joey Lomicky. “Physicians previously trained will be advised of the new recommendations, and all new training going forward will be include these updates before using the EnVeo R Delivery System.”
- FDA Gives Greenlight for Low-Risk TAVR Study with CoreValve
- Reduced Leaflet Motion in Bioprosthetic Aortic Valves Not Uncommon But Remedied by Anticoagulation
- TAVR With CoreValve Device Superior to Surgery at 1 Year
Medtronic. Urgent Field Safety Notice: Medtronic EnVeo R Delivery System: http://www.bfarm.de/SharedDocs/Kundeninfos/EN/07/2016/6664-16_Kundeninfo_en.pdf?__blob=publicationFile&v=1. Accessed August 18, 2016.