MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 an unknown date in (b)(6) 2011, a 23mm regent valve was implanted.On (b)(6), the valve was explanted due to a thrombolic event and exchanged with a 21mm trifecta valve.The patient presented back to the cardiologists with breathlessness and investigations showed signs of calcification.On (b)(6) 2019, the trifecta valve was explanted and replaced with an unknown valve.The patient was reported to be stable.

Manufacturer Narrative

A thormbolic event and valve explant 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.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V.; lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• MDR Report Key: 9111290
• MDR Text Key: 159847377
• Report Number: 3003681312-2019-00007
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 3404610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TF-21A, (B)(4); TF-21A, (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR