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

Model Number 305U2J25

Device Problems Calcified (1077); Structural Problem (2506); Material Deformation (2976)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Thrombus (2101); Regurgitation (2259); Stenosis (2263); Cusp Tear (2656); Fibrosis (3167); No Code Available (3191)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection observed the stent posts slightly deflected and oval shaped.All leaflets were in the closed position and were slightly stiff but flexible, except where pannus, thrombus and calcification were noted.Hematoma was observed on all tissue adjacent to the base stitching at the inflow aspect.Cuspal damage was noted on the lunula of the left cusp (lc).Damage was consistent with abrasion of the lc against the bias cloth of the outflow rail.The free margin and lunula of the non-coronary cusp (ncc) appeared thickened.Thrombus filled the belly of the right cusp (rc).Pannus filled the belly of the ncc.Visible calcification was observed on the lunula of rc (outflow) and also on the rc at inflow aspect.All commissures were intact.No dehiscence observed.Thin pannus lined the inflow, extending from the base stitching to the tissue and into all inferior coaptive areas.Pannus was observed on all superior coaptive areas of all commissures extending to the aortic wall on to the leaflets.Visible pannus was observed on the bellies of the ncc cusp and rc.An unknown amount of pannus appears to have been removed during explant.X-ray confirmed calcification on the lunula of the ncc cusp, the lunula of the rc, and on the lc.Conclusion: distortion of the annular ring could restrict the leaflets from fully opening and/or cause misalignment of leaflets during valve closure.In addition, distortion of the annular ring could result in more contact of the leaflet onto the cloth due to the altered position of the outflow rail and stent posts.Reduced performance of the valve was attributed to calcification and host tissue overgrowth.This finding is generally considered a patient-related condition.The implant date of the product could not be confirmed.The implant year was confirmed to be 2007.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 25 mm aortic bioprosthetic valve, the valve was explanted and replaced with a 23 mm non-medtronic valve.The reasons for replacement were reported as mild stenosis, trivial regurgitation, fibrin on and thickening of the right coronary cusp, a 1-2 mm tear on the left coronary cusp, and thickening of the non-coronary cusp.Overall, structural deterioration was noted.No additional adverse patient effects were reported. .

Manufacturer Narrative

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

• Brand Name: MOSAIC ULTRA PORCINE 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: 7679302
• MDR Text Key: 113707485
• Report Number: 2025587-2018-01717
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2012
• Device Model Number: 305U2J25
• Device Catalogue Number: 305U2J25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2007
• 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: 84 YR
• Patient Weight: 66