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

Model Number CRS

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Citation: kataruka a et al.Valve durability after transcatheter aortic valve implantation.J thorac dis.2018 nov;10(suppl 30):s3629-s3636.Doi: 10.21037/jtd.2018.07.38.Earliest date of publish used for event date.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 durability of valves following transcatheter aortic valve implantation.All data were collected from a systematic meta-analysis review of 12 studies.The overall study population included 18,814 patients (demographics not provided), an undisclosed number of which were implanted with medtronic corevalve and evolut pro bioprosthetic valves (no serial numbers provided).Among all corevalve patients, adverse events included: need for reintervention, transcatheter valve-in-valve implantation, leaflet calcification, leaflet tear, stent ¿creep¿ (migration), paravalvular leak, patient prosthesis mismatch, and increased mean gradients.Based on the available information, medtronic product may have been associated with the adverse events.Among all evolut pro (corevalve 3rd generation) patients, adverse events included: need for reintervention, leaflet calcification, leaflet tear, stent ¿creep¿ (migration), and unspecified valve issue.Based on the available information, medtronic product may have been associated with the adverse events.Among all corevalve and evolut pro (corevalve 3rd generation) patients, malfunctions included: stent fracture.Based on the available information, medtronic product may have been associated with the malfunction.No additional adverse patient effects or product performance issues were reported.

• Brand Name: COREVALVE TRANSCATHETER AORTIC 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: 8651006
• MDR Text Key: 146503814
• Report Number: 2025587-2019-01724
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/29/2019
• 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