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

Model Number 21AGFN-756

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/11/2020

Event Type  malfunction  

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) 2020, a 21 mm regent heart valve was selected for implant.While placing the valve the physician adjusted the direction of the leaflet and it fell off.The valve was replaced with a 19 mm regent heart valve and due to the need of a new valve there was a clinically significant delay in procedure.The patient was report to be in stable condition.

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.Both leaflets were dislodged from the orifice, with one leaflet returned with the valve.That leaflet was fractured, and one pivot guard was damaged.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the leaflet dislodgment and fractured pivot guard 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, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10270249
• MDR Text Key: 198700335
• Report Number: 3003681312-2020-00008
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 7392486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention