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

Model Number 310C31

Device Problems Calcified (1077); Occlusion Within Device (1423)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263)

Event Date 04/07/2014

Event Type  Injury  

Event Description

Medtronic received information that 3.5 years following the implant of this mosaic mitral valve in the tricuspid position, the valve was replaced due to calcification and insufficiency.The valve was replaced by another manufacturers mechanical prosthesis.The valve will be returned to medtronic for analysis.Additional information has been requested.

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

Upon receipt at medtronic¿s quality laboratory, remnants of chordae tendineae remained attached to the outflow.Part of the free margin and lunula of the left and right cusps were slightly stiff but flexible, except where host tissue extended on the inflow and outflow.The non-coronary cusp was stiff due to host tissue on the inflow and outflow.The free margin of the non-coronary cusp was folded back and adhered to the host tissue on the outflow.All leaflets were intact.All commissures were intact; however, host tissue overgrowth made it difficult to determine the condition.Pannus remained attached to the sewing ring on the inflow, over tissue and base stitching, into all inferior coaptive areas and 1 to 9 mm onto the inflow of all cusps, showing a reduced inflow orifice area.Pannus lined the outflow rail adjacent to both the non-coronary and left cusps, lining the outflow margins of attachments, encapsulating all stent posts and commissures, and filling and stiffening all cusps, showing evidence of restricted leaflet movement.Remnants of pannus remained attached to the sewing ring on the outflow adjacent to all cusps.Remnants of chordae tendineae were adhered to the pannus on the outflow.Radiography showed no evidence of mineralization in the valve and/or host tissue.Based on the received information and the returned product analysis, regurgitation could have resulted in the pannus filling the cusp outflow that caused an immobile leaflet/coaptation issues.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.Pannus formation is generally considered a patient-related condition.

• 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: 3785176
• MDR Text Key: 4433912
• Report Number: 2025587-2014-00251
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 310C31
• Device Catalogue Number: 310C31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2014
• Initial Date FDA Received: 05/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: 00040 YR
• Patient Weight: 70