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

Model Number MDT-TRANS VALVE

Device Problem Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Heart Failure (2206); Obstruction/Occlusion (2422)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

Citation: komatsu i et al.Preprocedural valvuloarterial impedance as a predictor of left ventricular ejection fraction improvement after transcatheter aortic valve replacement in patients with reduced left ventricular ejection fraction.Heart vessels.2020 sep;35(9):1209-1217.Doi: 10.1007/s00380-020-01591-3.Epub 2020 apr 6.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), evolut pro (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 investigation of the relationship between pre-procedural valuvuloarterial impedance and left ventricular ejection fraction improvement after transcatheter aortic valve replacement (tavr).All data were retrospectively collected from a single center between may 2012 to july 2017.The study population included 99 patients and was predominantly male with a mean age of 82 years.An unspecified number of patients were implanted with a medtronic transcatheter valve: corevalve, evolut r, or evolut pro.No serial numbers were provided.Among all patients, the freedom from all-cause and cardiovascular death during follow-up (median: 387 days, range: 179 to 715 days) was discussed.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, adverse events included: conversion to surgery during tavr, coronary obstruction, new permanent pacemaker implantation, percutaneous coronary intervention within three months of tavr, stroke, valve-in-valve implantation for an unknown reason, moderate to severe aortic regurgitation, and hospital readmission for heart failure.Based on the available information, medtronic product mayhave 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 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: 10619999
• MDR Text Key: 209585684
• Report Number: 2025587-2020-03000
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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
• Date Manufacturer Received: 09/09/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR