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

Model Number 305U229

Device Problems Perivalvular Leak (1457); Structural Problem (2506); Biocompatibility (2886)

Patient Problems Host-Tissue Reaction (1297); Corneal Pannus (1447); Aortic Regurgitation (1716)

Event Date 06/11/2018

Event Type  Injury  

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 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. .

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.

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.

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.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 7689469
• MDR Text Key: 114019235
• Report Number: 2025587-2018-01756
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169001480
• UDI-Public: 00643169001480
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2012
• 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: 66 YR
• Patient Weight: 141