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 Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problem Aortic Dissection (2491)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, aortic valve replacement, mitral annuloplasty(map), and maze procedure were performed on the patient with comorbitidy of aortic stenosis, mitral regurgitation, and atrial fibrillation.After the map with carpentier-edwards physio ring ii (edwards lifesciences), a 21mm sjm regent heart valve w/flex cuff was selected using a 905 sizer set and implanted in the patient's aortic position.However, the regent valve was slightly larger than the annulus.The physician implanted the valve although it seemed kind of tight within the annulus, but then the aortic root, the valsalva sinuses, began to tear.The valve was explanted, and a patch was used for the torn part.A smaller-sized 19mm sjm regent heart valve w/flex cuff was implanted, and the procedure was completed with no adverse consequence to the patient.

Manufacturer Narrative

An event of the valve being slightly larger than the annulus was reported.The investigation confirmed the device met dimensional and visual specifications when analyzed at abbott.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 reported event 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: 9789206
• MDR Text Key: 189443557
• Report Number: 2648612-2020-00024
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 6811523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR