MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Model Number	31MECJ-502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 31mm masters valve was selected for implant.The device was implanted but severe mitral regurgitation was observed via tee.The patient was placed back on bypass.The valve was inspected and confirmed there was no subvalvular obstruction or any hindrances to the leaflets.The device was explanted and replaced successfully with a 31mm carbomedics mechanical heart valve.The patient remained hemodynamically stable despite the bypass time being prolonged.
Additional Manufacturer Narrative
The reported event of regurgitation could not be confirmed.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event remains unknown.
Event or Problem Description
On (b)(6) 2019, a 31mm masters valve was selected for implant.The device was implanted but severe mitral regurgitation was observed via tee.The patient was placed back on bypass.The valve was inspected and confirmed there was no subvalvular obstruction or any hindrances to the leaflets.The device was explanted and replaced successfully with a 31mm carbomedics mechanical heart valve.The patient remained hemodynamically stable despite the bypass time being prolonged by 90 minutes.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8463914
• Report Number: 2648612-2019-00016
• Device Sequence Number: 13788480
• Product Code: LWQ
• UDI-Device Identifier: 05414734006613
• UDI-Public: 05414734006613
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: 31MECJ-502
• Device Lot Number: 6338326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/18/2019; 04/18/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/15/2019; 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR