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

Model Number 310C33

Device Problems Material Separation (1562); Incomplete Coaptation (2507); Biocompatibility (2886); Material Deformation (2976)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Dyspnea (1816); Hematoma (1884); Prolapse (2475)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that ten years and four months post implant of this 33mm mitral bioprosthetic valve, the patient presented with sudden onset of severe shortness of breath.The valve was explanted and replaced with a 31mm non-medtronic valve.Upon explant, one of the valve commissures was noted to be detached from the valve frame.All three leaflets were intact but the leaflets did not properly coapt.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the sewing ring was noted to be cut and removed, exposing sections of the stent.The valve was distorted (oval shaped).All leaflets were in the closed position; however, due to dehiscence at the right non-coronary stent post, the non-coronary cusp was crowded and folded within itself.All leaflets were slightly stiff but flexible.All leaflets were intact except where the commissure was detached/dehisced.The right cusp was prolapsed due to the detached/dehisced commissure.Small intracuspal hematomas were noted along the margin of attachments (inflow and outflow) and inferior captive areas of all cusps.The right non-coronary commissure was dehisced, possibly related to separation of the layers of the aortic wall behind the commissure.The sutures holding the aortic wall to the stent were intact.The start of a dehiscence was noted on the left right commissure.The left non-coronary commissure was intact, no dehiscence noted.From the inflow aspect, pannus was observed on the base stitching adjacent to the left cusp (lc) and right cusp (rc).Pannus was noted along the outflow rails adjacent to all cusps.Pannus appeared to have been removed along the base stitching of the non-coronary cusp (nc).Overall, an unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiologic evaluation revealed calcification along the right cusp (rc) outflow rail, non-coronary (nc) outflow rail, left right commissure dehiscence and right non-coronary commissure dehiscence.Conclusion: the dehiscence of the right non-coronary commissure may have caused the right cusp prolapse and led to incomplete coaptation.The distortion of the annular ring (oval shape) may have altered the stress placed on the commissures and leaflets.This alteration of the stress may play a role in dehiscence of a commissure.Also, the observed calcification may be another contributing factor to the commissure dehiscence.Reduced performance of the valve is attributed to host tissue overgrowth (pannus) and calcification.These findings are generally considered patient-related conditions.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: 7917160
• MDR Text Key: 121991130
• Report Number: 2025587-2018-02559
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2013
• Device Model Number: 310C33
• Device Catalogue Number: 310C33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2008
• 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: 48 YR
• Patient Weight: 63