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

Model Number	23VAVGJ-515
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Pleural Effusion (2010); Pulmonary Edema (2020); Thrombosis/Thrombus (4440)
Date of Event	01/31/2023
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
Crd_992 - valved grafts pas pl5012-195 r739423601.It was reported that on (b)(6) 2023, a 23mm masters mechanical heart valve was selected for an implant.While transporting the patient to the operating room to connect the patient to extracorporeal membrane oxygenation (ecmo), a pulmonary edema was noted before connecting.On (b)(6) 2023, after evaluation of laboratory tests, gasometry, chest x-ray, and left pleural puncture with evacuation of 200ml of blood fluid, the ecmo cannulas were removed.On (b)(6) 2023, chest computed tomography (ct) was performed which showed fluid and clots in the left pleural cavity.Thoracotomy was performed and 1700 ml of clots and fluid were evacuated.Hematoma of the left pleural cavity was also observed, but the site of bleeding was not visualized.The inr on (b)(6) 2023 was 3.4; inr on (b)(6) 2023 was 1.4.On (b)(6) 2023, inr was 1.27.The patient did not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.The patient was reported to be in stable condition.
Event or Problem Description
Crd_992 - valved grafts pas pl5012-195 r739423601 it was reported that on (b)(6) 2023, a 23mm masters mechanical heart valve was selected for an implant.While transporting the patient to the operating room to connect the patient to extracorporeal membrane oxygenation (ecmo), a pulmonary edema was noted before connecting.On (b)(6) 2023, after evaluation of laboratory tests, gasometry, chest x-ray, and left pleural puncture with evacuation of 200ml of blood fluid, the ecmo cannulas were removed.Device was successfully implanted.On (b)(6) 2023, chest computed tomography (ct) was performed which showed fluid and clots in the left pleural cavity.Thoracotomy was performed and 1700 ml of clots and fluid were evacuated.Hematoma of the left pleural cavity was also observed, but the site of bleeding was not visualized.The inr on (b)(6) 2023 was 3.4; inr on (b)(6) 2023 was 1.4.On 26 february 2023, inr was 1.27.The patient did not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of bleeding, pericardial effusion, pulmonary edema and thrombus was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Field beleived that the patient did not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.H6 medical device problem code: code 4001 was removed.

• 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: 16522170
• Report Number: 2135147-2023-01119
• Device Sequence Number: 19421038
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 8373171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White