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

Model Number 305J

Device Problem Structural Problem (2506)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Left Ventricular Hypertrophy (1949); Pseudoaneurysm (2605)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information this aortic bioprosthetic valve was explanted after an unknown duration of time due to pseudoaneurysm or enlargement of the aortic root.Upon explant, calcification, hypertrophy, elongation of the valve leaflet, and pannus were observed in the lesion.The valve was damaged when it was explanted.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection of the valve revealed that all the leaflets were slightly stiff but flexible except where host tissue extended on the inflow and outflow.Tears were observed in the left and right cusps adjacent to the left right commissure were associated with restricted leaflet movement due to host tissue overgrowth.The tears may have increased in size during explant with the removal of host tissue.The non-coronary left commissure showed possible host tissue overgrowth.The left and right cusps were slightly prolapsed.This may have been due to the tears and/or host tissue overgrowth in the left and right commissure.Tiny tears were observed in both the right non-coronary and left non-coronary commissures.Tears were noted in the left-right commissure.Tan pannus lined the tissue and base stitching adjacent to all cusps, over the inflow margin of attachment, into all inferior coaptive areas and onto all cusps showing a reduced inflow orifice area.Remnants of pannus remained attached to the sewing ring on the outflow, to outflow rails adjacent to the left and right cusps extending to the commissural area and leaflets.An unknown amount of pannus appears to have been removed on the inflow and/outflow.Radiography showed traces of mineralization in the right cusp, non-coronary left and left commissures and host tissue adjacent to the left cusp.Conclusion: 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.Although the device failure mechanism was not provided, based on the received information and the returned product analysis, the observed pannus overgrowth could have impaired the leaflet mobility.

• Brand Name: MOSAIC PORCINE 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: 5107740
• MDR Text Key: 26882097
• Report Number: 2025587-2015-01023
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2003
• Device Model Number: 305J
• Device Catalogue Number: 305J19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2000
• 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