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 Angina (1710); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891)

Event Date 12/10/2022

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: us0172-855, r731666301, r731672401, r731803601.It was reported that on (b)(6) 2022, a 25mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient with a history of kidney disease and a kidney transplant.On (b)(6) 2022, the patient was noted to be suffering from worsening kidney disease, the patient's baseline creatine levels were as follows, on (b)(6) 2022: 2.33 mg/dl and progressed to 2.98 mg/dl, and on (b)(6) 2023 = 2.93 mg/dl.This event resulted in hospitalization of the patient.On (b)(6) 2022, the patient developed sternal chest pain and an onset of hemoptysis.The patient was suffering from tachypnea, the patient became increasingly in need of oxygen.The patient had filled a basin with 100ml of a mix of blood and sputum.The patient's heparin infusion was then withheld.A chest x-ray revealed bilateral infiltrates.The patient was transferred to the intensive care unit.A laryngoscopy was performed and found no active bleeding of the upper airway.On (b)(6) 2022, the patient was noted the have an altered mental status.A computed tomography scan was performed and discovered that the patient was suffering from an intraparenchymal hemorrhage within the left parietal lobe, with a surrounding edema.Additionally, a subarachnoid hemorrhage was noted along the sulci in the left and right occipitoparietal lobes.There were no new large ischemic changes noted.The patient was taken back to the intensive care unit (icu) and monitored and neurological check ups.The patient was still in the icu on (b)(6) 2023, but alert and oriented.There was no treatment performed for either event.The bleeding is believed to be attributed to the anticoagulation from administration of heparin and warfarin, but without clear etiology.

Event Description

Subsequent to the previously filed report, additional information was received: the bilateral infiltrates detected via chest x-ray, were pleural effusions and possibly pulmonary edemas.The patient's worsening kidney disease is believed to be attributed to the patient's past medical history.On (b)(6) 2022, the patient was transfused 1 unit packed red blood cells (prbc) due to a hemoglobin of 6.7.On (b)(6) 2022, the patient was again transfused 1 unit prbc due to a hemoglobin of 5.9there was no allegation of malfunction against the 25mm sjm masters series valsalva aortic valved graft or procedure.The patient was reported to have been discharged home.

Manufacturer Narrative

An event of acute kidney failure, hemoptysis, angina, bleeding, and intracranial hemorrhage was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.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 all specifications.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.

• 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: 16277601
• MDR Text Key: 308573364
• Report Number: 2135147-2023-00349
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 7925036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2021
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: Black Or African American