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

Model Number AGFN-756

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

Patient Problem Arrhythmia (1721)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Clinical information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2023, a 21mm sjm regent heart valve w/flex cuff was implanted into a patient.It was reported that on (b)(6) 2023, an electrocardiogram was done and it indicated an arrhythmia.Medication was administered/adjusted.The patient is reported to be stable.No patient symptoms.It is believed this arrhythmia is possibly related to the device.

Manufacturer Narrative

An event of atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated that the patient had a history of atrial fibrillation , pulmonary arterial hypertension, pulmonary edema and rheumatic heart disease which could have been exacerbated by the procedure.However, based on the information received, the cause of the reported incident could not be conclusively determined.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: 16534846
• MDR Text Key: 311215139
• Report Number: 2135147-2023-01164
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 21AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 65 KG