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

Catalog Number 17AGFN-756

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Non specific EKG/ECG Changes (1817)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Clinical information: (b)(6).It was reported that on (b)(6) 2023, a 17mm sjm regent heart valve with flex cuff was successfully implanted in a patient.It was noted that on (b)(6) 2023, the patient was admitted to the hospital for treatment of persistent atrial fibrillation, that worsened since implant of the 17mm sjm regent heart valve with flex cuff.An electrocardiogram was performed and revealed atrial flutter and t-wave changes.The patient was also noticeably weaker and lost weight.On (b)(6) 2023, the patient was administered diltiazem.On (b)(6) 2023, the patient was administered alprostadil.It was also noted that the patient had also been administered anti-coagulants and gastric protection.On (b)(6) 2023, the decision was made to perform a catheter radiofrequency ablation.On (b)(6) 2023, the patient was discharged.The patient's atrial flutter, t-wave changes and worsening atrial fibrillation are attributed to the patient's primary rheumatic heart disease and past medical history.There is no allegation of malfunction against the abbott device or procedure.

Manufacturer Narrative

An event of worsening atrial fibrillation, atrial flutter and t-wave changes after almost 6 months of implant was reported.A returned device assessment could not be performed as the device remains implanted and 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined, however information from field indicated that reported event was attributed to the patient's primary rheumatic heart disease and past medical history.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17792589
• MDR Text Key: 323972804
• Report Number: 2135147-2023-04126
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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 Catalogue Number: 17AGFN-756
• Device Lot Number: C00003469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 50 KG