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 Codes	Stroke/CVA (1770); Transient Ischemic Attack (2109); Embolism/Embolus (4438)
Date of Event	12/16/2022
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
Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve with flex cuff was successfully implanted in a patient.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.On (b)(6) 2022, the patient underwent a head and neck computed tomography angiogram due to poor muscle strength in the left lower limb.Results indicated a transient ischemic attack in the right frontal area.On (b)(6) 2022, another computed tomography angiogram revealed an embolus.The patient's anticoagulant lipid regulation was continued and a plaque was stabilized.The patient was administered medication.The patient entered rehabilitation and was administered warfarin on (b)(6) 2022.The patient had a needling/acupuncture performed on (b)(6) 2022.On (b)(6) 2022, a craniocerebral computed tomography scan revealed that the infarct had slightly decreased in size.It was also noted that the patient's left lower limb muscle strength improved.On (b)(6) 2022, the patient was discharged.Two weeks post-discharged, it was noted that the patient's left lower limb muscle strength had normalized and the patient could walk normally.It's believed that the patient's stroke is due to an embolus, a brain drip irrigation that was performed during the implant procedure, and the implant procedure itself.There is no allegation of malfunction against the abbott device or procedure.
Additional Manufacturer Narrative
An event of stoke and embolism 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 received information, it was noted that the patient's stroke is due to an embolus.There is no allegation of malfunction against the abbott device or procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 health effect - clinical code: code 2109 removed.
Event or Problem Description
Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve with flex cuff was successfully implanted in a patient.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.On (b)(6) 2022, the patient underwent a head and neck computed tomography angiogram due to poor muscle strength in the left lower limb.Results indicated a stroke in the right frontal area.On (b)(6) 2022, another computed tomography angiogram revealed an embolus.The patient's anticoagulant lipid regulation was continued and a plaque was stabilized.The patient was administered medication.The patient entered rehabilitation and was administered warfarin on (b)(6) 2022.The patient had a needling/acupuncture performed on (b)(6) 2022.On (b)(6) 2022, a craniocerebral computed tomography scan revealed that the infarct had slightly decreased in size.It was also noted that the patient's left lower limb muscle strength improved.On (b)(6) 2022, the patient was discharged.Two weeks post-discharged, it was noted that the patient's left lower limb muscle strength had normalized and the patient could walk normally.It's believed that the patient's stroke is due to an embolus, a brain drip irrigation that was performed during the implant procedure, and the implant procedure itself.There is no allegation of malfunction against the abbott device or procedure.

• 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): 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: 18493894
• Report Number: 2135147-2024-00199
• Device Sequence Number: 3554291
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: C00003514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 80 KG