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

Model Number 19AGFN-756

Device Problem Fracture (1260)

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

Event Date 08/23/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 19 mm sjm regent heart valve w/flex cuff was selected for implant.During the procedure a leaflet fractured during rotation using a flexible valve holder.All pieces of the fractured leaflet were removed from the patient and another 19 mm sjm regent heart valve w/flex cuff (sn: (b)(4)) was successfully implanted.The procedure was extended by 30 minutes and the patient is reported to be recovering.The physician reports he used the flexible holder to rotate the valve rather than the rigid holder and considers this may have contributed to the fracture.

Manufacturer Narrative

Additional information received on patient ethnicity and weight.Patient status has been updated to stable.The reported event of a fractured and dislodged leaflet was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.There was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet or orifice damage.However, the damage was consistent with some external force applied to the valve which overstressed the carbon material.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2018, a 19mm sjm regent heart valve w/flex cuff was selected for implant.During the procedure a leaflet fractured during rotation using a flexible valve holder.All pieces of the fractured leaflet were removed from the patient and another 19mm sjm regent heart valve w/flex cuff (sn: (b)(4)) was successfully implanted.The procedure was extended by 30 minutes and the patient is reported to be stable.The physician reports he used the flexible holder to rotate the valve rather than the rigid holder and considers this may have contributed to the fracture.

• 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: 7863947
• MDR Text Key: 119803488
• Report Number: 2648612-2018-00074
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2023
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 6366386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 52