MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	25M-101
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission when received.
Event or Problem Description
25mm mecj implanted on (b)(6) 2016, patient reported with difficult in breathing, echo analysis showed that one leaflet had a restricted movement with gradient of 8mmhg and no valvular leak but there was mild regurgitation.Surgeon decided to replace the valve and implant a tissue prosthetic valve.
Additional Manufacturer Narrative
An event of an obstructed leaflet and regurgitation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: the reported event of restricted movement could not be confirmed.No tissue was found within the recessed pivot areas and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.The sewing cuff had been completely removed and was not returned for analysis.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event remains unknown.

• Brand Name: SJM MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 9746973
• Report Number: 3003681312-2020-00005
• Device Sequence Number: 19286448
• Product Code: LWQ
• UDI-Device Identifier: 05414734006323
• UDI-Public: 05414734006323
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2020
• Device Model Number: 25M-101
• Device Catalogue Number: 25M-101
• Device Lot Number: 4936988
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 09/29/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/24/2020; 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 29 YR