MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 21A-101

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020 dr.(b)(6) implanted 21mm mechanical heart valve in the aortic position-(b)(4) and a 27mm mechanical heart valve in the mitral position -(b)(4).On (b)(6) 2020, patient came back experiencing shortness of breath and chest discomfort.After investigation it was found that one leaflet of aortic valve is not working.An explant surgery is scheduled for (b)(6) 2020.

Manufacturer Narrative

An event of leaflet obstruction was reported.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10302239
• MDR Text Key: 199693807
• Report Number: 2648612-2020-00079
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005951
• UDI-Public: 05414734005951
• 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
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2019
• Device Model Number: 21A-101
• Device Catalogue Number: 21A-101
• Device Lot Number: 4916790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention