MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Catalog Number	23AGFN-756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
¿ investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm sjm regent heart valve w/ flex cuff valve was chosen for a aortic valve replacement (avr) procedure.The valve was implanted, four minutes after the procedure, the physician noticed oozing of blood from suture line in the cuff.The valve was explanted and a new 23mm sjm regent heart valve w/ flex cuff valve was implanted.The physician mentioned the weaving cuff was thin and porosity was more.The patient was reported discharged.
Additional Manufacturer Narrative
A returned device 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 defined manufacturing specifications.Based on the information received, the cause of the reported events could not be conclusively determined.The reported surgical intervention was a resulted of case-specific circumstances as the device was surgical removed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported events could not be conclusively determined.The reported surgical intervention was a resulted of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20801006
• Report Number: 2135147-2024-06058
• Device Sequence Number: 15427380
• Product Code: LWQ
• UDI-Device Identifier: 05415067044174
• UDI-Public: (01)05415067044174(17)281024(10)C00016587
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00016587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/18/2025; 02/12/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/22/2025; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male