MAUDE Adverse Event Report: HEART VALVES SANTA ANA MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	305U229
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Corneal Pannus (1447); Aortic Regurgitation (1716)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 4 years 9 months this 29 mm aortic bioprosthetic valve was explanted due to severe aortic regurgitation and paravalvular leak (pvl).The valve was successfully replaced with a non medtronic device.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed that the stent posts were slightly deflected and oval shaped.All leaflets were in the closed position, and slightly stiff but flexible.Cuspal damage was noted on the lunula of the left cusp, related to abrasion on the cusp against the bias cloth of the stent posts.Abrasion damage (non-through and through hole) was observed on the non-coronary cusp which was related to abrasion against the outflow rail.A small tear was noted on the right cusp adjacent to the non-coronary right commissures.The tear was associated with pannus overgrowth.All commissures were intact.There was no commissure dehiscence observed.There was no visible pannus observed on the inflow of the valve.Pannus was observed on all superior coaptive areas of all commissures extending to the aortic wall.The non-coronary right stent post was encapsulated with pannus extending to the outflow rail of the right cusp.The pannus extended to the non-coronary right commissures where a small tear was noted on the right cusp.The tear is likely associated with pannus overgrowth.An unknown amount of pannus appeared to have been removed during explant.Radiography showed no evidence of calcification in the valve.The device was placed on a coaptation test er.The leaflets remained in closed position however, gaps at the point of coaptation and pin hole gapping between the left cusp and right cusp coaptive ridges were observed.Due to the gaps, the pressure would not stay above 15 inches of water.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received information that medtronic received information that 4 years 9 months this 29 mm aortic bioprosthetic valve was explanted due to severe aortic regurgitation from a large paravalvular leak (pvl).The valve was successfully replaced with a non medtronic device.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis additional information: the valve was placed and tested on a coaptation tester, where is showed that the leaflets remained in a closed position with no gaps and pin holes.The pressure held at 20 inches of water.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7689469
• Report Number: 2025587-2018-01756
• Device Sequence Number: 13683028
• Product Code: LWR
• UDI-Device Identifier: 00643169001480
• UDI-Public: 00643169001480
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2017
• Device Model Number: 305U229
• Device Catalogue Number: 305U229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 08/13/2018; 07/27/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 07/26/2018; 08/13/2018; 08/21/2018; 10/03/2018; 10/05/2018
• 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: 66 YR
• Patient Weight: 141