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

Model Number 310J27

Device Problem Material Distortion (2977)

Patient Problems Host-Tissue Reaction (1297); Calcium Deposits/Calcification (1758); Hematoma (1884); Mitral Regurgitation (1964); Prolapse (2475); Cusp Tear (2656)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection showed the valve was slightly distorted; oval shaped.The sewing ring appeared to have been cut/damaged during explant.White multi-filament sutures were embedded in pannus on the existing sewing ring.All leaflets were in the closed position with wavy free margins.All leaflets were stiff but slightly flexible except where pannus extended on the inflow and outflow.A 9 mm tear was observed along the margin of attachment of the right cusp which appeared to be associated with restricted leaflet movement due to pannus overgrowth.Removal of pannus on the inflow during explant may have contributed to the increase in size of the tear.The right cusp appeared prolapsed due to the tear.Intercuspal hematomas were noted on the inflow aspect of all leaflets.Due to host tissue overgrowth, the condition of the non-coronary left commissure could not be determined.A small amount of pannus was noted on the superior coaptive area of the right left commissure and non- coronary right commissure.The tissue was intact at both commissures.There was no evidence of commissure dehiscence.Pannus lined the sewing ring on the inflow adjacent to all cusps, extending over the tissue and base stitching, over the inflow margin of the attachment into all inferior coaptive areas.A thin layer of pannus extended onto the tunica of all cusps.Pannus on the outflow covered the back and tops of the right left stent, post and non-coronary left stent post and extended over to the adjacent outflow rails.Pannus lined the outflow rail adjacent to all cusps, extending to the outflow margin of attachment, to all commissural areas encapsulating the non-coronary left stent post and commissure resulting in restricted leaflet movement.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography revealed minimal calcification embedded within the pannus along the sewing ring but did not show calcification in the leaflets.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.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 bioprosthetic valve, the valve was explanted and replaced due to severe mitral regurgitation caused by a tear in the leaflet.No adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Medtronic received additional information that this bioprosthetic valve was explanted 11 years and 9 months post implant.Implant date added.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: 7040397
• MDR Text Key: 92298499
• Report Number: 2025587-2017-02162
• 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,Followup
• Report Date: 12/12/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2010
• Device Model Number: 310J27
• Device Catalogue Number: 310J27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 11/17/2017; 12/08/2017
• Supplement Dates FDA Received: 11/17/2017; 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2005
• 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