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

Model Number 310CJ29

Device Problems Material Puncture/Hole (1504); Material Separation (1562); Patient-Device Incompatibility (2682); Material Deformation (2976); Insufficient Information (3190)

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

Event Date 09/04/2019

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 1 year and 5 months post implant of this 29mm bioprosthetic mitral valve, the patient is being evaluated for mitral valve replacement.The reason for evaluation was reported as a tear in one of the valve leaflets.No known interventions have occurred.

Manufacturer Narrative

Medtronic received information that one year and six months post implant of this 29mm bioprosthetic mitral valve, it was explanted and replaced due to a tear in one of the valve leaflets.The replacement valve model and size was not reported.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.A conclusive cause of the valve thrombosis and pannus could not be determined by the available information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction to event description: medtronic received additional information that an unknown duration later the valve was explanted and replaced.No additional adverse patient effects were reported. multiple attempts have been made to obtain additional information without success at this time.Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection showed that the valve was returned with green multifilament surgeon sutures attached to the sewing ring adjacent to the non-coronary cusp (nc).There was damage to the sewing ring, which likely occurred during the explant procedure.All leaflets were wavy and in the closed position.All leaflets were slightly stiff but flexible except where host tissue extends on the inflow and outflow.The right cusp was prolapsed due to tears and abrasions on the right cusp.A large intercuspal hematoma was found on the inflow non-coronary cusp with thrombotic fibrin growth on the outflow restricting leaflet movement.There was a cut on the non-coronary cusp likely occurring during explant.Tears and abrasions through the free margin and lunula of the right cusp were noted to be due to restricted leaflet movement against the thick, striation likely associated with host tissue infiltration.Abrasions were found on the right cusp adjacent to the left right commissure.The left non-coronary and right non-coronary commissures were intact.Remnants of pannus remained attached to the sewing ring adjacent to the right and left cusps.An unknown amount of pannus appeared to have been removed during explant.Radiologic evaluation revealed no calcification on the leaflets and/or host tissue.Conclusion: investigation is ongoing, a supplemental report will be submitted should any new or additional information become available.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: 9081167
• MDR Text Key: 158958124
• Report Number: 2025587-2019-02848
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2020

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: 10/04/2021
• Device Model Number: 310CJ29
• Device Catalogue Number: 310CJ29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 01/08/2020; 03/10/2020
• Supplement Dates FDA Received: 12/30/2019; 01/23/2020; 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR