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

Model Number 305C

Device Problem Improper Flow or Infusion (2954)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: since the valve has been implanted for almost 9 years, it¿s very unlikely that the stenosis is due to any potential manufacturing issue.The common probable cause for stenosis is due to pannus overgrowth.From the information received the valve remained implanted.Without the return of the valve for analysis, a root cause of the issues cannot be determined.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.

Event Description

Medtronic received information that 8 years 10 months post implant of this aortic bioprosthetic valve it was replaced valve-in-valve with a transcatheter aortic valve replacement due to low flow, low gradients and severe aortic stenosis.Due to the patients low ejection fraction the fact that he lives over 4 hours away an aicd was placed the next day.No additional adverse patient effects were reported.  medical history includes: angina and heart failure, hypertension and dyslipidemia.

• Brand Name: MOSAIC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 6888381
• MDR Text Key: 87158594
• Report Number: 2025587-2017-01664
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00721902694752
• UDI-Public: 00721902694752
• 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
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2013
• Device Model Number: 305C
• Device Catalogue Number: 305C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2008
• 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: 81 YR
• Patient Weight: 110