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

Model Number 25VAVGJ-515

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

Patient Problems Dyspnea (1816); Pain (1994); Pleural Effusion (2010); Renal Failure (2041); Pseudoaneurysm (2605); Respiratory Insufficiency (4462)

Event Date 04/01/2023

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: eu3549 - 354 (r750360501, r751468701, r753412001) it was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was implanted.A maze procedure and a left atrial appendage closure were also performed during the same surgery.There were no intraprocedural adverse events or device deficiencies recorded.On (b)(6) 2023, the patient experienced newly onset acute kidney injury/renal failure.A prerenal or inflammatory cause after post-operative volume fluctuations or temporarily reduced perfusion was most likely per physician.Patient had elevated creatinine, and hospitalization was prolonged.On (b)(6) 2023, an x-ray and transthoracic echocardiogram revealed that patient had left pleural effusion with atelectasis and less pronounced right pleural effusion.Patient also had dyspnea, partial respiratory insufficiency, and high oxygen demand.A pleural drain was inserted on the left side, and approximately 1000ml of old blood-serous secretion was drained.On (b)(6) 2023, the patient complained of pain and a pseudoaneurysm was detected in the left groin on ultrasound.On (b)(6) 2023, the patient received an aneurysmectomy of the left groin to treat the pseudoaneurysm.The patient status was reported as stable.

Manufacturer Narrative

An event of renal failure and pseudoaneurysm was reported.A returned device assessment, to see if there was any damage or anomalies which could have contributed to or caused damage at the access site could not be performed as the device remains implanted and was not returned for analysis.Physician believed prerenal or inflammatory cause after post-operative volume fluctuations or temporarily reduced perfusion which may cause reported event of renal failure.Field indicated that the reported event was not due to the procedure or the abbott device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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 (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: 16903754
• MDR Text Key: 314925061
• Report Number: 2135147-2023-02026
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8446947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Race: White