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

Model Number 310C29

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/22/2014

Event Type  Injury  

Event Description

Medtronic received information that an unidentified bioprosthetic mitral heart valve, believed to be a medtronic product, had been replaced with a 29mm medtronic bioprosthetic mitral heart valve within 90 days of its implant.The information was received when its replacement device was explanted; no other device or complaint details were available.No adverse patient effects beyond the reoperation/replacement were reported.

Manufacturer Narrative

Additional information has been requested from the explanting physician.A review of medtronic¿s databases did not show any previously submitted complaints for the event date.A separate report is being filed on the second replacement device.(b)(4).

Manufacturer Narrative

Multiple attempts to obtain additional information/product return from the site have been unsuccessful.A device history record review could not be performed as the serial number was not provided.Without the reason of the explant, the failure mode could not be determined.Without the return of the valve, a root cause of the event was unable to be determined.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4275499
• MDR Text Key: 5030454
• Report Number: 2025587-2014-00936
• Device Sequence Number: 1
• Product Code: LWR
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310C29
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 00027 YR