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

Model Number 25M-101

Device Problem Obstruction of Flow (2423)

Patient Problem Mitral Regurgitation (1964)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission when received.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 181439041
• Report Number: 3003681312-2020-00005
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006323
• UDI-Public: 05414734006323
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 04/22/2020; 09/29/2020
• Supplement Dates FDA Received: 04/24/2020; 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 29 YR