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

Model Number 305

Device Problem Hole In Material (1293)

Patient Problem Aortic Regurgitation (1716)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be filed upon completion of returned device analysis and investigation.

Event Description

Medtronic received information that nine years post-implant of this bioprosthetic valve, the device was explanted and replaced with a mechanical valve due to severe aortic regurgitation and aortic dilatation.During the explant, the physician noted a perforation of a valve leaflet.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve appeared slightly distorted and stent posts appeared slightly deflected.Small needle holes along the sewing ring showed placement of implantation sutures.No implanting sutures found on the sewing ring.All leaflets were in the closed position with wavy free margins.All leaflets were slightly stiff but flexible except where host tissue and/or intercuspal hematoma extended on the inflow and outflow of the noncoronary cusp.A hole/abrasion was found on the belly of the left cusp.This type of damage is consistent with damage due to contact with the bias cloth of the outflow.An abrasion on the free margin and lunula of the left cusp appeared to be associated with contact with the bias cloth at the noncoronary left stent post.A tear was noted on the free margin and lunula of the left cusp.There were no long suture tails returned, however tears and abrasions along the free margin and/or lunula of the cusps are consistent with historical events for contact with a long suture tail and/or wear on the bias cloth.All commissures appeared intact.Glistening off white pannus remained attached to the sewing ring at the right cusp outflow rail.A thin layer of pannus found at the based stitching at the inflow aspect, extending to the inferior coaptive areas.Prominent pannus embedded with intercuspal hematoma found encroached 1 to 3 mm onto the noncoronary cusp showing e vidence of a reduced inflow orifice area.Traces of pannus were observed on the belly of the left cusp (inflow aspect) adjacent to the hole.Pannus was found on top of the commissures.An unknown amount of pannus appears to have been removed on the inflow and outflow during explant.Radiography did not reveal any evidence of calcification.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 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: 6694581
• MDR Text Key: 79317451
• Report Number: 2025587-2017-01124
• 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,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2013
• Device Model Number: 305
• Device Catalogue Number: 305CJ21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2008
• 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: 46 YR
• Patient Weight: 52