MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. MASTERS SERIES CAVGJ,AUS TRALIAN,25MM; HEART-VALVE, MECHANICAL

Model Number 25CAVGJ-514 00

Device Problem Obstruction of Flow (2423)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/ method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2008, a 25mm masters mechanical heart valve was implanted as part of a bentall procedure.On (b)(6) 2020, it was reported that the patient presented with symptomatic aortic stenosis with a peak velocity of 3.4 m/s and the patient has a pertinent medical history of gastrointestinal bleeding while on anticoagulation therapy.The patient was scheduled for reoperation on (b)(6) 2020 with planned conversion from a mechanical heart valve to a biological valve.The patient status was reported as unknown.Additional information was requested, however was not able to be obtained.

Manufacturer Narrative

An event of stenosis and planned explant of the valve 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: MASTERS SERIES CAVGJ,AUS TRALIAN,25MM
• 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: 10705328
• MDR Text Key: 212292777
• Report Number: 2648612-2020-00098
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2012
• Device Model Number: 25CAVGJ-514 00
• Device Catalogue Number: 25CAVGJ-514 00
• Device Lot Number: 0002097163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR