MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MDT-TRANS VALVE

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problems Intimal Dissection (1333); Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Insufficiency, Valvular (1926); Perforation of Vessels (2135); Rupture (2208); Cardiac Tamponade (2226); Blood Loss (2597)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

Citation: pineda am et al.Transcatheter aortic valve replacement for patients with severe bicuspid aortic stenosis.Am heart j.2020 jun;224:105-112.Doi: 10.1016/j.Ahj.2020.02.003.Epub 2020 feb 8.Earliest date of publish used for date of event.Medtronic products referenced: corevalve (pma# p130021, pro code npt), evolut r (pma# p130021, pro code npt).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding an evaluation of the outcomes following transcatheter aortic valve replacement (tavr) in patients with bicuspid aortic valve stenosis compared to patients with trileaflet aortic valve stenosis.All data were retrospectively collected from a single center between april 2011 and november 2016.The study population included 567 patients (50 with bicuspid aortic valve stenosis, 517 with trileaflet aortic valve stenosis) and was predominantly male with a median age of 81 years and 88.4% were white.Of those, 333 patients were implanted with medtronic corevalve or evolut r self-expanding transcatheter valves.No serial numbers were provided.Among all patients treated with self-expanding transcatheter valves (corevalve or evolut r), 71 all-cause deaths occurred within two years after tavr.No further details were provided about the deaths.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients in the study population, intra-operative adverse events included: valve malposition requiring intervention, ventricular perforation or tamponade, annular rupture, conversion to open-heart surgery, and aortic dissection.Based on the available information, medtronic product may have been associated with these adverse events.Among all patients treated with self-expanding transcatheter valves (corevalve or evolut r), post-operative in-hospital adverse events included: new permanent pacemaker implantation, ischemic stroke, unplanned cardiac or vascular surgery, new onset atrial fibrillation, mild to severe paravalvular regurgitation/leak, major vascular complications, and life-threatening or disabling bleeding.Based on the available information, medtronic product was associated with these adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC TRANSCATHETER VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10605805
• MDR Text Key: 209144431
• Report Number: 2025587-2020-02965
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 81 YR