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

Model Number 310C29

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Split, Cut or Torn (4008)

Patient Problem Mitral Regurgitation (1964)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned.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 during the implant procedure of a 29 mm bioprosthetic mitral valve, mitral regurgitation was observed.It was reported that the surgeon felt the regurgitation was due to the valve size and a replacement was done using a 27 mm bioprosthetic mitral valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed discoloration showing evidence of blood contact.All leaflets were in a semi-relaxed positions, which is a standard finding for this valve as it is processed with the leaflets in a relaxed state.All leaflets were flexible with the left cusp and non-coronary cusp intact.Cuspal damage was noted on the right cusp.A section of the right cusp appeared to have been removed with a longitudinal incision observed along the lunula.The incision had linear markings, damage consistent with a laceration made by a sharp instrument.Multiple downstream manufacturing checkpoints would have identified this degree of damage.All commissures appeared intact.The valve measured at 29.06mm, which meets the specifications for this valve of 29 ± 0.5mm.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.It is possible that the valve may have been oversized, which led to the regurgitation.Based on the risk analysis and historical trend, cuspal tear and/or commissure dehiscence were the common mechanisms which could lead to regurgitation.It is possible that the physician damaged the right cusp during the implant procedure, resulting in the leaflet being unable to close properly.D10: device available for evaluation? updated h3: device evaluated? updated 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, REPLACEMENT
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10298994
• MDR Text Key: 199645405
• Report Number: 2025587-2020-02271
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00643169594852
• UDI-Public: 00643169594852
• 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: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310C29
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 79