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

Model Number 310J25

Device Problems Material Rupture (1546); Material Distortion (2977)

Patient Problems Corneal Pannus (1447); Heart Failure (2206); Prolapse (2475); Cusp Tear (2656)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis pending.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 approximately 10 years post implant of this mitral bioprosthetic valve, the patient presented with heart failure.The device was explanted and replaced.The physician stated that there was a leaflet tear of the valve caused by structural valve dysfunction (svd).The physician also stated that he thought svd in 10 years of use was rather early.No additional adverse patient effects were reported. .

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, visual examination revealed the valve was slightly distorted.Pledgets were seen embedded in pannus around the sewing ring.All leaflets were in the closed position.The right cusp was prolapsed due to a leaflet tear/abrasion adjacent to the left right stent post.All leaflets were slightly stiff but flexible except where pannus extended onto the tissue (outflow).Tears/abrasions were noted in the belly of the right and the left cusps which is consistent with historical findings of cusp contact with the bias cloth.Damage size may have increased during explant.All stent posts were encapsulated with pannus and all outflow rails extending to the base stitching and 1 to 3 mm onto all cusps reducing the inflow orifice area.Pannus extended to all superior coaptive areas and some areas of the sewing ring.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Pannus overgrowth was observed on the valve which extended from the left non-coronary stent post to the left cusp, which may have contributed to the tear of the left cusp (during valve opening, the left cusp contacted the bias cloth and may have also contacted the pannus).Deflection of the stent posts and/or distortion of the valve can result in more contact of the leaflet onto the cloth due to the altered position of the outflow rail and stent posts.The tear and abrasions seen in the right / left cusps may have been a result of the altered position of the stent post since the position of the deflection resulted in the narrowing of this outflow rail opening.Exactly when and how the stent post deflection or valve distortion occurred cannot be determined; however, per medtronic¿s inspection procedure each valve is inspected for distortion/deflection and this valve was confirmed to have passed the inspection prior to release for distribution.Radiography revealed calcification embedded in pannus on the left right stent post and along the sewing ring.No calcification was found on the leaflets.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.Pannus overgrowth is an inherent risk of surgical valve replacement.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC 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: 6906094
• MDR Text Key: 87840447
• Report Number: 2025587-2017-01732
• 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: 11/15/2017

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: 07/20/2010
• Device Model Number: 310J25
• Device Catalogue Number: 310J25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 90 YR