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

Model Number 305U2J21

Device Problems Material Rupture (1546); Material Distortion (2977)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Cusp Tear (2656)

Event Type  Injury  

Manufacturer Narrative

The product has been returned for analysis.Following the completion of the analysis, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 13 years post implant of this bioprosthetic valve, the valve was explanted and replaced by another manufacturer's product due to dehiscence of the right coronary cusp and the cusp was torn from the commissure.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed the valve was slightly distorted; oval shaped and the stent posts were slightly deflected.The non-coronary cusp and right cusp were in the closed position while the left cusp was in opened position.All leaflets were stiff but slightly flexible except where pannus was noted.Abrasions were observed on the non-coronary cusp and on the left cusp which are consistent with historical findings of cusp contact with the bias cloth.There was no evidence of commissure dehiscence.Remnants of the torn left cusp remained attached at the right left commissure and at the non-coronary left commissure.The non-coronary right commissure was intact.Pannus lined the base stitching to the inflow margin of the attachment, encroaching up to 10 mm on to the cusps and into the inferior coaptive areas between all cusps which would have significantly impaired the leaflet mobility.Small amount of pannus was observed on the superior coaptive areas of all commissures.Remnants of pannus were observed on the outflow rail and extending to the non-coronary right stent post.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography revealed intrinsic calcification at the right left commissure and at the lunula of the right cusp.Conclusion: reduced performance of the valve is attributed to calcification and host tissue overgrowth.These findings are generally considered a patient-related condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC ULTRA 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 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: 7135028
• MDR Text Key: 95387924
• Report Number: 2025587-2017-02516
• 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: Initial,Followup
• Report Date: 01/25/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2009
• Device Model Number: 305U2J21
• Device Catalogue Number: 305U2J21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2004
• 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