MAUDE Adverse Event Report: HEART VALVES SANTA ANA MOSAIC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 310

Device Problems Material Distortion (2977); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Hematoma (1884); Mitral Regurgitation (1964); Cusp Tear (2656)

Event Date 02/01/2018

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 10 years and 2 months post implant of this mitral bioprosthetic valve, the valve was explanted and replaced with a non-medtronic valve due to regurgitation of the bioprosthetic valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection revealed the valve appeared to have been cauterized.The sewing ring was damaged, likely during the explant procedure.The valve was slightly distorted; oval shaped.All leaflets were in the closed position and slightly stiff but flexible.In the inflow, the non-coronary (nc) cusp exhibited a hematoma.Explant damage due to cauterization was found on the sewing ring, onto the base stitching and onto the right cusp.A thin layer of pannus was observed along the base stitching of the left cusp.The non-coronary cusp exhibited a tissue tear along the base stitching that appeared to be related to pannus overgrowth.At the inflow aspect, a tear was observed on the tissue area with the hematoma.The sewing ring and the base stitching of the right cusp (rc) appeared to have been damaged by the cauterization during the explant procedure as the area was burnt.The rc was torn off the aortic wall at the right left commissure.The tear appeared to be due to the pannus on the stent post that extended to the aortic wall of the right left commissure.The commissure attachment of the left cusp had started to detach/dehisce.The detachment was noted at the superior coaptive area and had not exposed the aortic wall/commissure manufacturing sutures.The non-coronary right commissure and non-coronary left commissure were intact.Pannus was observed on the nc outflow rail that extended onto the aortic wall area and onto the margin of attachment and on to the nc.Pannus was also observed on the left cusp (lc) outflow rail that extended to the aortic wall area and onto to the margin of attachment of the lc.Pannus lined the base stitching of the lc (inflow aspect).All commissures showed evidence of pannus.The non-coronary right and left commissures exhibited pannus over the superior coaptive areas and along the aortic walls.The left right commissure exhibited a slight commissure dehiscence.Pannus was noted on the dehisced edged of the lc.Pannus was observed on the aortic wall, which appears to have contributed to the rc tear.Remnants of pannus were observed on the back of the stent posts.An unknown amount of pannus appeared have been removed during the explant procedure.Radiography did not reveal calcification in the valve.  conclusion: 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.

• Brand Name: MOSAIC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 7286502
• MDR Text Key: 100600660
• Report Number: 2025587-2018-00429
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2010
• Device Model Number: 310
• Device Catalogue Number: 310J29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2005
• 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: 77 YR
• Patient Weight: 55