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

Model Number MDT-TRANS VALVE

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Obstruction of Flow (2423)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Rupture (2208); Obstruction/Occlusion (2422); Cardiovascular Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/27/2021

Event Type  Injury  

Manufacturer Narrative

Citation: meguro k., et al.Transcatheter aortic valve replacement in patients with a small annulus from the (b)(6) nationwide registry (j-tvt).Circ j.(b)(6) 2021; 85(7):967-976.Doi: 10.1253/circj.Cj-20-1084.Epub (b)(6) 2021.Pmid: 33642425.Earliest date of publication used for date of event.Medtronic products referenced: corevalve, evolut r (pma# (b)(4)).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 via literature regarding the short-term outcomes of patients with small aortic annulus sizes who underwent transcatheter aortic valve replacement (tavr) and the differences in outcomes of intra-annular versus supra-annular transcatheter heart valves.All data were collected from a japanese national clinical registry (j-tvt) between august 2013 and december 2017.The study population included 5870 patients (predominantly female, mean age 85 years), 600 of whom were implanted with medtronic corevalve and 1166 of whom were implanted with medtronic evolut r bioprosthetic valves (unique device identifier numbers not provided).Among all patients, 44 patients died within 30 days post-tavr, however no further information was provided.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: annulus rupture during tavr, coronary obstruction, need to convert to open-heart surgery, severe patient-prosthesis mismatch (ppm),need for new pacemaker implantation, strokes and moderate-severe paravalvular leaks (pvls).Based on the available information medtronic product may have been associated with the 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 DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12713442
• MDR Text Key: 284451493
• Report Number: 2025587-2021-03284
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 49