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

Model Number 310C29

Device Problem Calcified (1077)

Patient Problems Host-Tissue Reaction (1297); Calcium Deposits/Calcification (1758); Mitral Insufficiency (1963); Mitral Regurgitation (1964); Regurgitation (2259)

Event Date 11/30/2018

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 seven years and ten months post implant of this 29mm bioprosthetic mitral valve, it was explanted and replaced with 31mm valve of the same model.The valve was replaced due to significant regurgitation and calcification.It was reported that the insufficiency was due to iv drug abuse.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed there were two remnant pieces of host tissue and two white remnant sutures returned.There were cuts and / or tears along the sewing ring which likely occurred during the explant procedure.There were blue monofilament sutures attached to the sewing ring.The valve appeared slightly distorted and oval shaped.The right and left cusps are in the closed position with gaps noted between the coaptive ridges.The non-coronary cusp was in the open position with the lunula resting against the inner outflow rail.All leaflets were wavy, and slightly stiff but pliable except where host tissue and / or calcification was present.There was extensive extrinsic calcification nodules on the lunula and belly of the right cusp (rc), as well as on the belly and outflow margin of the left cusp.There was tissue deterioration due to visible calcification observed on the belly of the right cusp (rc).There were abrasions on the belly of the non-coronary (nc) cusp which appeared to be associated to contact with the outflow.There were calcification nodules noted on the superior coaptive junction of the right left commissure, along with focal extrinsic calcification nodules on the lunula of the right cusp (rc) adjacent to the right non-coronary commissure.There was host tissue (pannus) extended over the left non-coronary commissure.Pannus lined the tissue and base stitching adjacent to all cusps, over the inflow margin of attachment and into all inferior coaptive areas.Pannus was found on the outflow, lining the sewing ring and the outflow rail, which extends to the back of all stent posts.An unknown amount of pannus appeared to have been removed during the explant procedure.Radiography revealed significant calcification on the right cusp (rc) and, to a lesser extent, on the on left cusp (lc).Conclusion: reduced performance of the valve is attributed to host tissue overgrowth along with calcification.These findings are generally considered a patient-related condition.Conclusion: reduced performance of the valve is attributed to host tissue overgrowth along with calcification.These findings are generally considered a patient-related condition.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 8196012
• MDR Text Key: 131392282
• Report Number: 2025587-2018-03539
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00613994688927
• UDI-Public: 00613994688927
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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: 08/10/2015
• Device Model Number: 310C29
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 04/19/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR