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 Hematoma (1884); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Pericardial Effusion (3271); Convulsion/Seizure (4406); Thrombosis/Thrombus (4440)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was implanted into a patient.After the procedure, the patient had increased drainage, clots, and a hematoma.A thoracotomy was performed and the tamponade decompressed.In addition, the patient was transfused plasma.The patient had ventricular fibrillation.Defibrillation was administered twice.On (b)(6) 2023, seizure was observed with the following symptoms: tremor of the left limbs, nystagmus, the left lower limb and upper limbs moved spontaneously, the right limbs did not move.The patient was diagnosed with cytotoxic edema in the course of ischemic changes in the acute phase.Medication was administered and the patient was transfused red blood cells.It was noted that the patient had low levels of fibrinogen.The device remained implanted and was reportedly working as intended.The patient was reported to be in stable condition.

Event Description

Crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was implanted into a patient.After the procedure, the patient had increased drainage, clots, and a hematoma.A thoracotomy was performed and the tamponade decompressed.In addition, the patient was transfused plasma.The patient had ventricular fibrillation.Defibrillation was administered twice.On (b)(6) 2023, seizure was observed with the following symptoms: tremor of the left limbs, nystagmus, the left lower limb and upper limbs moved spontaneously, the right limbs did not move.The patient was diagnosed with cytotoxic edema in the course of ischemic changes in the acute phase.Medication was administered and the patient was transfused red blood cells.It was noted that the patient had low levels of fibrinogen.The device remained implanted and was reportedly working as intended.The patient was reported to be in stable condition.Subsequent to the previously filed report, additional information was received that on (b)(6) 2023, the patient was transfused with red blood cells.On (b)(6) 2023, it was noted that the patient fluid present in the right pleural cavity.The decision was made to perform a surgical puncture and drainage of 1000 ml serious bloody fluid.

Manufacturer Narrative

An event of presence of increased drainage, clots, a hematoma , pericardial effusion and tamponade was reported.A returned device assessment could not be performed as the device remains implants was not returned for analysis.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 that the reported event was not device related and that there was no allegation of malfunction against the abbott device.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: 16619367
• MDR Text Key: 312124375
• Report Number: 2135147-2023-01353
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8261271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• 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; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White