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

Model Number 23AGN-751

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that a 23mm sjm regent heart valve was selected for an implant on (b)(6) 2021.One of the leaflet dislodged (as one piece) into the left ventricle (lv) after suturing and testing with the rubber tester.There was no resistance felt when the physician rotated the valve with the valve rotator.Device was explanted and when the physician removed the suturing, another leaflet also dislodged/ fall to the ground.There was a significant clinical delayed which could have been dangerous to patients life.A non abbott valve was implanted and the patient remained hemodynamically stable through the second implant.No additional information was provided.

Manufacturer Narrative

Additional information sections: d9, g3, h1, h2, h3, h6, h10.An event of the leaflet falling out when tested with the leaflet tester and the other falling out when the valve was removed 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 REGENT 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12659086
• MDR Text Key: 277217008
• Report Number: 2648612-2021-00098
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006101
• UDI-Public: 05414734006101
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Device Lot Number: 7761611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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 Sex: Male