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

Model Number	AGFN-756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2023, a 19mm sjm regent heart valve with flex cuff was successfully implanted in a patient.A 905 mechanical heart valve sizer set had been used to size the 19mm sjm regent heart valve with flex cuff.The patient had not been administered heparin for procedure, but had a noted activated clotting time (act) level of 136 seconds.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.Post-implant procedure, the patient presented an increase in drainage from their drainage tube with bleeding from the mediastinum.The patient had an international normalized ratio (inr) of 1.22.Hemostatic medication was administered, but the patient's condition did not improve.Post-operative bleeding was suspected and an emergency thoracoscopic assisted thoracotomy was performed.The patient also required a transfusion.Post-intervention the patient's bleeding decreased and the patient had little drainage flow.The patient was recovering at the time of report, with a most recent inr of 1.67.There was no prolonged hospitalization due to this event.The cause of the bleeding is attributed to the poor coagulation function of the patient.
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) - regent china pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 19mm sjm regent heart valve with flex cuff was successfully implanted in a patient.A 905 mechanical heart valve sizer set had been used to size the 19mm sjm regent heart valve with flex cuff.The patient had not been administered heparin for procedure, but had a noted activated clotting time (act) level of 136 seconds.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.Post-implant procedure, the patient presented an increase in drainage from their drainage tube with bleeding from the mediastinum.The patient had an international normalized ratio (inr) of 1.22.Hemostatic medication was administered, but the patient's condition did not improve.Post-operative bleeding was suspected and an emergency thoracoscopic assisted thoracotomy was performed.The patient also required a transfusion.Post-intervention the patient's bleeding decreased and the patient had little drainage flow.The patient was recovering at the time of report, with a most recent inr of 1.67.There was no prolonged hospitalization due to this event.The cause of the bleeding is attributed to the poor coagulation function of the patient.
Additional Manufacturer Narrative
An event of bleeding from the mediastinum 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, field noted that the cause of bleeding was due to the poor coagulation function of the patient.

• 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: 16916593
• Report Number: 2135147-2023-02072
• Device Sequence Number: 20552613
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• 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: 2023
• 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): 07/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: C00004400
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 77 KG