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

Model Number 310CJ27

Device Problem Structural Problem (2506)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/13/2014

Event Type  Injury  

Manufacturer Narrative

A visual examination of the device was performed upon receipt.The stent posts appeared slightly bent.Device analysis confirmed the cuspal tears.The holes and elongations in the right cusp appeared to be due to repeated contact of the leaflet with the base suture line.The hole closer to the left/right inferior coaptive area exhibited characteristics of cloth or suture contact wear, but does not appear to have been due to contact with the base suture.It is possible that a long suture tail on the ventricular aspect of the sewing ring was in contact with the leaflet in this location, but due to the absence of a large portion of the sewing ring and implant sutures, there was no way to confirm this possibility.All wear in this leaflet was likely related to positioning of the right cusp well above the inflow plane of the stent.Tissue deterioration was also observed in the septal shelf or muscle bar on the right cusp.The loss of myocardium was secondary to the wear/holes, as they would have allowed exposure of the underlying myocardium, leading to a host reaction.Pannus was also observed.Radiography performed at medtronic showed no evidence of calcification.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Based on the received information and the returned product analysis, the reported regurgitation was most likely due to the cuspal tear and abrasion.The long suture tail wear, leaflets contacting with bias cloth, and stent distortion could be the potential causes of the cuspal tears.Cuspal tear is a known failure mode and is addressed in the current device risk management files.

Event Description

Medtronic received information that approximately two years after the implant of this bioprosthetic tissue valve, the valve was explanted and replaced with another manufacturer¿s device due to moderate/severe central mitral regurgitation.Upon explant, visual inspection noted one of the valve leaflets had two perforations.No adverse patient effects were reported.

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.(b)(4).

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: 4308375
• MDR Text Key: 12855023
• Report Number: 2025587-2014-00995
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2015
• Device Model Number: 310CJ27
• Device Catalogue Number: 310CJ27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2010
• 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