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

Model Number 305-23

Device Problems Material Erosion (1214); Material Perforation (2205); Biocompatibility (2886); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Aortic Insufficiency (1715); Calcium Deposits/Calcification (1758); No Information (3190)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: 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 an unknown duration post implant of this bioprosthetic valve, the valve was explanted.The reason for explant was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

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

Event Description

Medtronic received information that an unknown duration post implant of this aortic bioprosthetic valve, the valve was explanted and replaced with a non-medtronic bioprosthetic valve.The reason for replacement was reported as insufficiency resulting from a hole in a leaflet.No additional adverse patient effects were reported. .

Manufacturer Narrative

Corrected description of event.The product has been returned to medtronic and the analysis is in progress.A supplemental report will be submitted upon completion of the analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately 12 years post implant of this aortic bioprosthetic valve, the valve was explanted and replaced with a non-medtronic bioprosthetic valve.The reason for replacement was reported as insufficiency resulting from a hole in a leaflet.No additional adverse patient effects were reported. .

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the valve was distorted (oval shaped).The valve exhibited stent cloth damage that was consistent with damage that likely occurred during explant.All leaflets were in the closed position with the leaflets¿ free margins and lunula deteriorated due to calcification.All leaflets were slightly stiff but flexible except where the calcification extended on the inflow and outflow.The right cusp (rc) exhibited tissue deterioration from the lunula to the free margin.Missing tissue was observed on the belly of the rc.Extrinsic calcification was observed on the belly extending towards the lunula and free margin (inflow and outflow).There was thinning tissue noted on the left cusp (lc) adjacent to the margin of attachment (inflow view).The cusp was torn from the lunula to the margin of attachment.Tissue deterioration, possibly derived from the non-coronary right commissure, was observed on the non-coronary cusp (nc) through the free margin to the lunula.The observations on the rc, lc and nc were likely associated with calcification.Tissue deterioration due to calcification was observed on the non-coronary right and left right commissures.Extrinsic calcification nodules were observed on those commissures.Calcification nodules were observed on the superior coaptive area of the non-coronary left commissure.From the inflow aspect, thin layers of remnant pannus were observed along the sewing ring.Remnants of pannus were observed on the sewing right adjacent to the non-coronary cusp and non-coronary left stent post.Overall, an unknown amount of pannus appeared to have been removed during the explant procedure.Radiologic examination revealed calcification along the right cusp (rc), the left right commissure as well as on the non-coronary right commissure.Minimal calcification was revealed on the left cusp (lc) lunula and non-coronary left commissure.Conclusion: 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 AORTIC 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: 7895920
• MDR Text Key: 120960269
• Report Number: 2025587-2018-02476
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2010
• Device Model Number: 305-23
• Device Catalogue Number: 305-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2005
• 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
• Patient Age: 65 YR
• Patient Weight: 76