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

Model Number 310CJ27

Device Problems Break (1069); Calcified (1077); Material Separation (1562); Incomplete Coaptation (2507); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problem Mitral Regurgitation (1964)

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

The product was returned.Following the completion of the 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 11 years and 7 months post implant of this 29mm bioprosthetic mitral valve, the leaflets were explanted and a 25mm non-medtronic bioprosthesis was sutured into the sewing cuff of the previous bioprosthesis.The valve was replaced due to severe regurgitation.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the explanted device was a 27mm bioprosthetic mitral valve, not a 29mm valve.No additional adverse patient effects were reported.Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the sewing ring was removed exposing the stent, which was likely a result of the explant process.There was a break on the exposed stent with adjacent damage to the base stitching and outflow rail.All leaflets were slightly stiff but flexible, which is a normal finding for this valve.All leaflets appeared slightly twisted and in the closed position with a gap between the right and non-coronary free margins.The start of commissure dehiscences were noted along the aortic wall of the right cusp of the right/non-coronary superior coaptive area and along the aortic wall of the non-coronary and left cusps of the left/non-coronary commissure area.The right/left commissure was dehisced.The sutures holding the aortic wall to the stent post was intact.Host tissue was not observed on the valve.Radiography revealed calcification on the right/non-coronary and left/non-coronary commissural areas.Conclusions: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The commissure dehiscence on every post contributed to the gap between the right cusp and non-coronary cusp leaflets.The improper closure of the leaflets resulted in the reported regurgitation.Commissure dehiscence is one of the most common failure modes which could lead to regurgitation.Calcification is one of the common causes of the commissure dehiscence, and is normally a patient-related condition.D4: model #, catalog #, expiration date, serial #, udi # added h3: device evaluated? updated h4: device mfg date added h6: coding updated 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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10009627
• MDR Text Key: 196462912
• Report Number: 2025587-2020-01507
• Device Sequence Number: 1
• Product Code: LWR
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/19/2020

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: 04/30/2013
• Device Model Number: 310CJ27
• Device Catalogue Number: 310CJ27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 44