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

Model Number MDT-TRANS VALVE

Device Problems Partial Blockage (1065); Degraded (1153); Reflux within Device (1522)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/13/2021

Event Type  Injury  

Event Description

Medtronic received information via literature comparing valve-in-valve transcatheter aortic valve replacement (viv tavr) versus re-do surgical aortic valve replacement (savr) for bioprosthetic valve degeneration.All data were collected from a meta-analysis literature review of multiple databases from inception through august 2020.Nine observational studies were analyzed, comprising a combined population of 2,891 patients who were predominantly male with a mean age of 75 years.The viv tavr group involved 1,395 patients and the re-do savr group involved 1,496 patients.Multiple manufacturer¿s devices were implanted in the study population.Among all patients, implants involved several medtronic models, including hancock and mosaic surgical bioprosthetic valves and corevalve and engager transcatheter bioprosthetic valves (unique device identifier numbers not provided).Among all patients, cumulative mortality (mean follow-up of 26 months) was 22% in the viv group and 19.6% in the re-do savr group.No further information was provided on the nature/causes of these deaths in the meta-analysis.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: bioprosthetic valve degeneration, leading to aortic stenosis and/or aortic regurgitation, requiring viv tavr or re-do savr to resolve.Based on the available information medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: thandra a.; et al.Valve-in-valve transcatheter aortic valve replacement versus redo surgical valve replacement for degenerated bioprosthetic aortic valve: an updated meta-analysis comparing midterm outcomes.Catheter cardiovasc interv.2021 jun 1;97(7):1481-1488.Doi: 10.1002/ccd.29541.Pmid: 33580743.Epub 2021 feb 13 earliest date of publication used for date of event.Medtronic products referenced: hancock (pma# p870078, product code: dye); (pma# p990064, product code: dye); corevalve (pma# p130021, 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.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: 15090187
• MDR Text Key: 296467183
• Report Number: 2025587-2022-02084
• 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: 07/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1