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

Model Number 17AGFN-756

Device Problems Gradient Increase (1270); Device Damaged by Another Device (2915)

Patient Problem Aortic Regurgitation (1716)

Event Date 12/25/2019

Event Type  Injury  

Manufacturer Narrative

An event of high gradient, regurgitation, valve explant, and damaging the leaflet of the valve while attempting to re-implant it 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.Please note,the instructions for use, artmt100078770 version a warn that the valve is for single use only.

Event Description

On (b)(6) 2019, a 17mm sjm regent heart valve w/flex cuff was implanted in the patient's aortic position.High gradient was observed after the implant and while confirming hemodynamics, aortic regurgitation was observed.The physician explanted the valve once and implanting the valve was attempted again, but the leaflet of the valve got damaged during the second attempt.An ats open pivot bileaflet heart valve (manufacturer: medtronic, 16mm, serial# unknown) was implanted and the procedure was completed with no adverse consequence on the patient.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout the procedure.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9615676
• MDR Text Key: 177819315
• Report Number: 2648612-2020-00008
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2020
• Device Model Number: 17AGFN-756
• Device Catalogue Number: 17AGFN-756
• Device Lot Number: 5199574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• 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): Other; Required Intervention