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

Model Number 27VAVGJ-515

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

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 02/17/2023

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: 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.

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.

Event 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.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• Type of Device: 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
• MDR Text Key: 311701702
• Report Number: 2135147-2023-01282
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Race: White