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

Model Number MDT-TRANS VALVE

Device Problems Backflow (1064); Partial Blockage (1065); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506); Migration (4003)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 09/27/2021

Event Type  Injury  

Event Description

Medtronic received information via literature regarding the indications and outcomes after surgical explantation of transcatheter aortic valve replacements (tavr).All data were collected from an international multi-center clinical registry between november 2009 and september 2020.The study population included 269 patients (predominantly male, mean age (b)(6) years), 110 of whom underwent prior tavr with various medtronic self-expanding transcatheter aortic bioprosthetic valves, including corevalve, evolut r, evolut pro/pro+ and engager models (unique device identifier numbers not provided).Among all patients, in-hospital, 30-day and 1-year post-explant mortality was 11.9%, 13.1% and 28.5%, respectively.No further details were provided.Based on the available information medtronic product may have been associated with the deaths.Among all patients, adverse events included: need for surgical explantation of tavr valves, strokes, endocarditis, paravalvular leak (pvl), structural valve degeneration (svd), patient-prosthesis mismatch (ppm), unfavorable anatomy, valve migration, aortic/mitral regurgitation, mitral stenosis, decompensated heart failure and aortic aneurysms.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.

Manufacturer Narrative

Citation: bapat v., et al.Surgical explantation after tavr failure: mid-term outcomes from the explant-tavr international registry.Jacc cardiovasc interv.2021 sep 27;14(18):1978-1991.Doi: 10.1016/j.Jcin.2021.07.015.Pmid: 34556271 publisher: jacc cardiovasc in terv earliest date of publish used for date of event.Medtronic products referenced: corevalve, evolut r, evolut pro/pro+ (pma# (b)(4), product code: npt); engager (pma# n/a, product code: n/a).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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13796807
• MDR Text Key: 287343335
• Report Number: 2025587-2022-00706
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

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?: Yes
• Device Operator: Lay User/Patient
• 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: 02/16/2022
• Initial Date FDA Received: 03/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ICD, UNKNOWN IPG
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male