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

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hematoma (1884); Perforation (2001)
Date of Event	08/27/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amulet steerable delivery sheath.The delivery system was attempted to be used but then was downsized to a 12f amplatzer torqvue 45x45 delivery sheath.The amulet occluder was implanted.An abbott perclose closure device was used to close the access site.The patient remained hemodynamically stable throughout the procedure.Under an hour after the procedure, the patient had developed a hematoma in post-operative recovery at the delivery system's access site.A venous perforation of undetermined location was determined to be present.Contralateral access was obtained, and stents were placed in the femoral artery and the femoral vein in attempt to stop the bleeding.The bleeding was unable to be controlled.This vascular complication ultimately led to the patient's death.No pericardial effusion was noted.
Additional Manufacturer Narrative
An event of hematoma immediately after the implant and patients 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.Based on the information received, the cause of the reported incident could be procedural related but cannot be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2024, a 20mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amulet steerable delivery sheath.The delivery system was attempted to be used but then was downsized to a 12f amplatzer torqvue 45x45 delivery sheath.The amulet occluder was implanted.An abbott perclose closure device was used to close the access site.The patient remained hemodynamically stable throughout the procedure.Under an hour after the procedure, the patient had developed a hematoma in post-operative recovery at the delivery system's access site.A venous perforation of undetermined location was determined to be present.Contralateral access was obtained, and stents were placed in the femoral artery and the femoral vein in attempt to stop the bleeding.The bleeding was unable to be controlled.This vascular complication ultimately led to the patient's death.No pericardial effusion was noted.

• 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: 20270527
• Report Number: 2135147-2024-04655
• Device Sequence Number: 7240434
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)260731(10)9173258
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 9173258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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
• Patient Sex: Unknown