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

Model Number 25AJ-501

Device Problem Perivalvular Leak (1457)

Patient Problems Congestive Heart Failure (1783); Mitral Insufficiency (1963); Tricuspid Insufficiency (2111)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

An event of paravalular leak and patient death due to cardiac failure, mitral insufficiency, and tricuspid insufficiency was reported.The results of the investigation are inconclusive since the device remains implanted 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.

Event Description

On an unknown date, a 25mm masters mechanical heart valve was implanted.On (b)(6) 2017, during hospital follow up, the patient had suspected paravalvular leakage and secondary surgery was performed to repair the paravalvular leak.The patient was stable.On (b)(6) 2017, during hospital follow up, the patient passed away due to cardiac failure, mitral insufficiency, and tricuspid insufficiency.The valve remains implanted.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9385397
• MDR Text Key: 168271144
• Report Number: 2648612-2019-00092
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734021128
• UDI-Public: 05414734021128
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2020
• Device Model Number: 25AJ-501
• Device Catalogue Number: 25AJ-501
• Device Lot Number: 5096038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR