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

Model Number 29VAVGJ-515

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  Injury  

Event Description

Clinical information: (b)(4) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.On (b)(6) 2022, it was noted that the patient had developed temporary amaurosis fugax in their right eye for one minute.A computed tomography scan was performed and found no intracranial hemorrhage, infarct, hydrocephalus, and no signs of herniation.An angiogram was performed and found regular contrast of the patient's cervical and intracranial vessels.An ultrasound was also performed and found normal findings of extracranial and transcranial blood supplying arteries.It was also discovered that the patient tested positive for covid-19.There was no treatment performed/required.The patient was discharged on (b)(6) 2022, but was re-admitted to the hospital on (b)(6) 2022 due to possible thrombus that had adhered to the 29mm sjm masters series valsalva aortic valved graft.Transesophageal echocardiogram (tee) showed deposits adhered to the 29mm sjm masters series valsalva aortic valved graft implanted in the patient.On (b)(6) 2022, cardiac catherization was performed and found regular movement of the valve's leaflets.No patient consequences were reported.

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).Subsequent to the previously file reported additional inforamtion was received that, the deposits/potential thrombus visualized using transthoracic echocardiogram.However, there was no thrombus confirmed via transesophageal echocardiogram.The patient had been prescribed anticoagulants post-implant and they were compliant with their medication.On 14 december 2022, the patient's international normalized ratio was 2.9 and on 07 january 2023, it was 3.2.The patient does not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.The 29mm sjm masters series valsalva aortic valved graft was functioning as intended.The patient did not experience any clinical signs or symptoms due to this event and was resolved on 22 december 2022.The cause of the patient's temporary amaurosis fugax is beleive to have been from a covid-19 infection, but is not certain.The cause/source of the deposits remains unknown, but there is no allegation of malfunction against the 29mm sjm masters series valsalva aortic valved graft or procedure.

Manufacturer Narrative

An event of amaurosis fugax and possible thrombus/deposits was reported.A returned device assessment could not be performed as the device remains implanted and 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 patient's temporary amaurosis fugax could be related to the patient's reported covid infection.The field also indicated that the potential thrombus or deposits could not be seen in tee.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - clinical code: code 4440 removed.H6 medical device problem code: code 4001 removed.

• 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: 16127874
• MDR Text Key: 306986282
• Report Number: 2135147-2023-00125
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009508
• UDI-Public: 05414734009508
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 29VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 7806218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Race: White