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

Model Number 305UJ

Device Problem Material Rupture (1546)

Patient Problem Corneal Pannus (1447)

Event Date 08/14/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 11 years post implant of this 21 mm bioprosthetic valve, the valve was explanted and replaced with a 19 mm valve.At explant, the surgeon noted that the stent section was torn on both sides of the rcc (right coronary cusp).Pannus overgrowth was also observed on the lower part of the valve.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the sewing ring appeared to have been removed during explant exposing the stent.All leaflets were in the closed position with all adjacent free margins not touching each other.All leaflets were slightly stiff but flexible except where the pannus extended onto the non coronary cusp with leaflet damage noted on right coronary cusp (rc).The lunula of the rc was found torn from the nrc commissure to the middle of the rc cusp.Calcification was noted on the torn area.The rc was found torn at the left right commissure.The right cusp was also found torn at the right noncoronary commissure.The left noncoronary commissure appeared intact.However, small amount of pannus was observed on top of their superior coaptive area.Pannus extended to the tissue and base stitching, onto the inflow margin of attachment of the noncoronary cusp, into the inferior coaptive area between left cusp and non coronary cusp.Pannus extended 2 to 4 mm showing a reduced inflow orifice area.Pannus also extended from the base stitching and onto the margin of attachment of the nc at the outflow aspect due to the removal of the sewing ring, amount of pannus at explant cannot be confirmed.Radiography showed minimal calcification at the right noncoronary commissure and at the torn lunula of the rc.Conclusion: based on these observations the most likely cause of the observed tears was due to the presence of calcification.Pannus extended to the tissue and base stitching, onto the inflow margin of attachment of the noncoronary cusp, and into the inferior coaptive area between left cusp and non-coronary cusp.The pannus extended 2 to 4 mm onto the nc showing a reduced inflow orifice area.Pannus also extended from the base stitching onto the margin of attachment of the nc at the outflow aspect.Due to the removal of the sewing ring, the amount of pannus at the time of explant cannot be confirmed.Radiography of the device confirmed minimal calcification at the right noncoronary commissure and at the torn lunula of the rc.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: 6867084
• MDR Text Key: 86244681
• Report Number: 2025587-2017-01610
• 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: 10/20/2017

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: 01/18/2011
• Device Model Number: 305UJ
• Device Catalogue Number: 305UJ21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2006
• 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: 85 YR