MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Model Number	9-TV45X45-14F-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Intracranial Hemorrhage (1891); Respiratory Insufficiency (4462)
Date of Event	11/07/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on an unknown date, a 14f amplatzer torqvue 45x45 delivery sheath was used for a procedure.The patient has a past medical history of cabg, bioprosthetic avr, cerebral aneurysm, and atrial fibrillation.On (b)(6) 2024, the patient presented to the hospital with stroke symptoms.Computed tomography (ct) for large vessel occlusion was negative.Within 8 hours of admission, the patient became bradycardic with worsening nih score.Repeat ct showed new intracerebral hemorrhage.Tranexamic acid bolus was given and on (b)(6) 2024, the patient was transferred to another hospital for admission.The patient received medications and maintained ability to speak and follow commands.On (b)(6) 2024, the patient began to develop respiratory failure.Therefore, on (b)(6) 2024, the patient was intubated."despite attempts made to optimize clinical condition," the patient continue to fail.The patient denied trach and on (b)(6) 2024, terminal extubating was performed; the patient passed shortly after extubating.
Additional Manufacturer Narrative
An event of intracranial hemorrhage, respiratory failure, bradycardia, and death was reported.A returned device assessment could not be performed as the device 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported patient effect could not be conclusively determined.The reported hospitalization and unexpected medical intervention were due to case-specific circumstances, as the patient was admitted, received medication, and required intubation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23089961
• Report Number: 2135147-2025-05277
• Device Sequence Number: 13389080
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)260731(10)9174506
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 9-TV45X45-14F-080
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 9174506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female