MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL

Model Number	29VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/14/2022
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
(b)(4) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 29mm sjm masters series valsalva aortic valved graft was implanted into a patient.Post operation the patient developed cardiogenic/hypovolemic shock.The patient received a short infusion of nicardidine and lactated ringers solution with resolution of the shock.No patient consequences were reported.
Event or Problem Description
(b)(4) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 29mm sjm masters series valsalva aortic valved graft was implanted into a patient.During the procedure, the patient had to briefly be taken off their vasopressors.Post operation the patient developed cardiogenic/hypovolemic shock.The patient received a short infusion of nicardidine and lactated ringers solution with resolution of the shock.No patient consequences were reported.There was no allegation of malfunction, no surgical intervention performed.The patient is reported to be discharged.It was thought that the shock was caused by the patients need for vasopressors.During the procedure, the patient had to briefly be taken off their vasopressors.It was thought that the shock was caused by the patients need for vasopressors.The patient is reported to be discharged.No allegation of malfunction, no surgical intervention performed.
Additional Manufacturer Narrative
An event of cardiogenic shock post-operation after the valve implant procedure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated there were no complications during the implant procedure.Information from the field indicated the patient needed vasopressors and they were taken off during the procedure.It was indicated that the cardiogenic shock was caused shock by the patient's need for vasopressors.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• 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: 16130861
• Report Number: 2135147-2023-00137
• Device Sequence Number: 16941007
• Product Code: LWQ
• UDI-Device Identifier: 05414734009508
• UDI-Public: 05414734009508
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 01/30/2023

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 Expiration Date: 04/30/2025
• Device Model Number: 29VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 8628250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White