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

Catalog Number 25VAVGJ-515

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Respiratory Insufficiency (4462)

Event Date 09/08/2023

Event Type  Injury  

Event Description

Clinical information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.It was noted that on (b)(6) 2023, the patient had a neurological event where a chronic right occipital hypodensity was detected.A computed tomography scan was performed and revealed no acute intracranial hemorrhage, extra-axial fluid collection, or major vascular territorial infarct.

Manufacturer Narrative

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

Event Description

Clinical information: (b)(6) - 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 successfully implanted in a patient.It was noted that on (b)(6) 2023, the patient had a neurological event where a chronic right occipital hypodensity was detected.A computed tomography scan was performed and revealed no acute intracranial hemorrhage, extra-axial fluid collection, or major vascular territorial infarct.Subsequent to the previously filed report, additional information was received that there was no difficulty implanting the 29mm sjm masters series valsalva aortic valved graft.The patient remained hemodynamically stable throughout the implant procedure and there was no clinically significant delay in procedure reported.The patient was noted to have experienced episodes of confusion, right side weakness and increased respiratory requirements with a 5 on the national institutes of health stroke scale.The decision had been made to intubate the patient and provide supplemental oxygen.A computed tomography scan of the head revealed a hypodensity of the left thalamus and a possible infarct in the left frontal cortex.However, a computed tomography angiogram showed no large vessel occlusion or significant stenosis.The patient's condition significantly improved overnight.The patient was extubated and able to move their right and left side, follow commands, but had mild dysarthria.Another computed tomography scan of the head confirmed only left thalamic stroke of unclear acuity.There was no initial or prolonged hospitalization due to this event and the patient did not experience a permanent injury or disability.The patient's stroke/ chronic left hypodensity is suspected be due to an emboli caused from aortic dissection.It was noted that the patient's aortic dissection and a mal-perfusion to the right common carotid and left renal artery were seen prior to the implant procedure.There was no other intervention performed/required.There was no allegation of malfunction against the abbott device or procedure the patient was stable and discharged at the time of report.

Manufacturer Narrative

An event of patient's stroke/ chronic left hypodensity after valve implantation was reported.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 it is suspected that the event was due to an emboli caused from aortic dissection seen prior to the implant procedure.However, based on the information received, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Manufacturer Narrative

An event of patient's stroke/ chronic left hypodensity after valve implantation was reported.It was also reported that the patient had bleeding and anemia prior to the device entering the patient.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 it is suspected that the event was due to an emboli caused from aortic dissection seen prior to the implant procedure.However, based on the information received, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

Clinical information: 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 successfully implanted in a patient.It was noted that on (b)(6) 2023, the patient had a neurological event where a chronic right occipital hypodensity was detected.A computed tomography scan was performed and revealed no acute intracranial hemorrhage, extra-axial fluid collection, or major vascular territorial infarct.Subsequent to the previously filed report, additional information was received that there was no difficulty implanting the 29mm sjm masters series valsalva aortic valved graft.The patient remained hemodynamically stable throughout the implant procedure and there was no clinically significant delay in procedure reported.The patient was noted to have experienced episodes of confusion, right side weakness and increased respiratory requirements with a 5 on the national institutes of health stroke scale.The decision had been made to intubate the patient and provide supplemental oxygen.A computed tomography scan of the head revealed a hypodensity of the left thalamus and a possible infarct in the left frontal cortex.However, a computed tomography angiogram showed no large vessel occlusion or significant stenosis.The patient's condition significantly improved overnight.The patient was extubated and able to move their right and left side, follow commands, but had mild dysarthria.Another computed tomography scan of the head confirmed only left thalamic stroke of unclear acuity.There was no initial or prolonged hospitalization due to this event and the patient did not experience a permanent injury or disability.The patient's stroke/ chronic left hypodensity is suspected be due to an emboli caused from aortic dissection.It was noted that the patient's aortic dissection and a mal-perfusion to the right common carotid and left renal artery were seen prior to the implant procedure.There was no other intervention performed/required.There was no allegation of malfunction against the abbott device or procedure the patient was stable and discharged at the time of report.Subsequent to the previously filed report, additional information was received that the patient had intraoperative blood loss anemia, prior to the 25mm sjm masters series valsalva aortic valved graft entering the patient on (b)(6) 2023.However, post-procedure it was noted that the patient's hemoglobin (6.8 g/dl) and hematocrit (21%) values continued to decrease and bleeding is suspected.Through the next few days the patient was transfused with a total of (b)(4) units of packed red blood cells.

• 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: 17862240
• MDR Text Key: 324818555
• Report Number: 2135147-2023-04290
• Device Sequence Number: 1
• Product Code: LWQ
• 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,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8951425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2023
• 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; Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White