MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305U

Device Problems Occlusion Within Device (1423); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 3 years and 5 months post implant of this aortic bioprosthetic valve, a transcatheter bioprosthetic valve was implanted valve-in-valve. the reason for the intervention was reported as patient prosthesis mismatch (ppm), aortic insufficiency and stenosis.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the aortic insufficiency of the bioprosthetic valve was severe.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7309901
• MDR Text Key: 101388224
• Report Number: 2025587-2018-00478
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169001664
• UDI-Public: 00643169001664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2019
• Device Model Number: 305U
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 06/19/2018
• Date Device Manufactured: 07/18/2014
• 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): Required Intervention
• Patient Age: 75 YR