MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2021, during procedure, while placing a 23mm regent flex-cuff valve, the user reported that the leaflets were not functioning properly.The valve leaflets did not open at all, they were stuck.While still on pump, he removed the 23 regent and did a root enlargement and put in another 23mm regent with a standard cuff.I asked the coordinator if the first one was oversized and if it was putting too much pressure on the leaflets.She said she doesn't think so but he did do a root enlargement and the next 23mm regent leaflets functioned properly.While transitioning off bypass the patient became hemodynamically unstable.The physician reported that the patient required defibrillation x 2 and that the patient sustained severe hypotension despite efforts to replace the patients volume through the aortic cannula.After bypass was re-initiated the patient eventually re-stabilized.Pt had sievers type 0 bicuspid aortic valve, but the original valve sized nicely to his annulus and there was nothing difficult related to his anatomy.

Manufacturer Narrative

An event of the leaflets not opening after implant was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The bottom orifice rim was noted to be chipped, consistent with damage at explant.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined, though information from the field indicated that a root enlargement was done prior to implanting another 23mm regent valve which functioned properly.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• MDR Report Key: 11333857
• MDR Text Key: 241931675
• Report Number: 3007113487-2021-00003
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 7299193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR