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

Model Number 310C25

Device Problems Material Deformation (2976); Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problems Host-Tissue Reaction (1297); Cusp Tear (2656); No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

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 five years and nine months post implant of this bioprosthetic valve, the valve was explanted and replaced due to an anterior medial leaflet tear.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection noted that the stent posts were slightly deflected and oval shaped, with pannus surrounding the entire measurement area of the valve.All leaflets were stiff but flexible.The non coronary cusp (nc) was in the open position, while the left coronary cusp (lc) and the right coronary cusp (rc) were in a closed position due to the leaflet tears.There was tissue deterioration of the lc and rc at the lr commissure due to visible mineralization.Tears were observed at both the lr commissure and right cusp.There was tissue deterioration due to mineralization on the lr commissure.All other commissures were intact with no deterioration.There was tan pannus observed along the outflow rails of all three commissures as well as the observed outflow sewing cuff adjacent to the right cusp extending to the nc cusp and ending at the left cusp.Pannus was observed encapsulating the ncl and lr stent posts extending to the superior coaptive area of the commissures.The entire inflow sewing cuff was covered with pannus.An unknown amount of pannus appeared to have been removed on the inflow and outflow rails.Radiologic evaluation showed mineralization on the lr commissure and on the right cusp.Conclusion: a review of the device history record (dhr) was performed for this valve.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Based on the received information and device analysis, the calcification could be the potential cause of the cuspal tear.Updated event date: 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 MITRAL BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7734399
• MDR Text Key: 115525172
• Report Number: 2025587-2018-01916
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2017
• Device Model Number: 310C25
• Device Catalogue Number: 310C25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2012
• 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: 71 YR
• Patient Weight: 41