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

Model Number	27VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/17/2023
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: crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.The valve was sized using a abbott/sjm mechanical heart valve sizer set.The were intraprocedural complications reported.On (b)(6) 2023, the patient was hospitalized due to fluid being detected via transthoracic echocardiogram (tte) in the patient's pericardial sac.The same pericardial sac fluid was detected on tte on (b)(6) 2023 and (b)(6) 2023.On (b)(6) 2023, the decision was made to perform a surgical intervention from access under the xiphoid process, that resulted in 700 ml of blood being aspirated from the patient's pericardial sac.No patient consequences were reported.No additional information was provided.
Event or Problem Description
Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).Subsequent to the previously filed report, additional information was received.The masters valve was sized using a sizer set.No difficulties in implanting the masters valve was reported.Pericardial effusion was noted and drainage of the pericardial sac was performed.Post-procedure, the patient's antithrombotic regiment consisted of heparin, however warfarin was added after drainage of the pericardial sac.The patient remained hemodynamically stable throughout the procedure and no clinically significant delay was reported.The patient was discharged home in stable condition.There are no allegations of malfunction with the masters valve.The implanter classified the event as related to the procedure and is not device related.
Additional Manufacturer Narrative
An event of pericardial effusion and cardiac tamponade 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 allegation of malfunction against the abbott device.The field believed the event was procedure related.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.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 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 Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16584854
• Report Number: 2135147-2023-01282
• Device Sequence Number: 1688307
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 05/12/2023

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: 09/30/2024
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 8519918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Race: White