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

Model Number	310C25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been returned to medtronic.At the conclusion of the analysis, a supplemental report will be submitted.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 or Problem Description
Medtronic received information that 6 years and 2 months post implant of this bioprosthetic valve, the valve was explanted due to regurgitation.No further adverse patient effects were reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, green multifilament sutures remained attached to the sewing ring with suture holes evident.Damage was noted along the sewing ring most likely occurred during the explant of the device.The stent posts appeared slightly deflected.All leaflets were in the closed position with the adjacent free margins not touching each other.All leaflets were stiff but flexible.The left and noncoronary cusps were intact.A tear/abrasion was noted on the belly of the right cusp which appeared to be consistent with historical finding for cusp contact with the bias cloth.All commissures appeared intact.The right noncoronary was slightly covered with pannus on the top of the superior coaptive area.Pannus lined the inflow and outflow aspects of the sewing ring.An unknown amount of pannus appeared to have been removed during the explant of the device.The right noncoronary stent p ost was encapsulated by pannus.Conclusion: based on the information received, deflection of the stent posts in this case can potentially result in more contact of the leaflet onto the cloth due to the altered position of the outflow rail and stent posts.Exactly when and how the stent post deflection occurred cannot be determined.Each valve is inspected for deflection/distortion and this valve passed the inspection prior to release for distribution.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Pannus overgrowth is a known inherent risk of surgical valve replacement.The most likely cause for the reported regurgitation was due to the observed tear/abrasion in the right cusp.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6834799
• Report Number: 2025587-2017-01519
• Device Sequence Number: 1600587
• Product Code: LWR
• UDI-Device Identifier: 00613994689139
• UDI-Public: 00613994689139
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 310C25
• Device Catalogue Number: 310C25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75