MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Catalog Number	9-ATV07F45/60
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: crd_1032 - sh device registry, patient site id: (b)(6) (b)(4).It was reported that on (b)(6) 2024, a 14mm amplatzer septal occluder was successfully implanted in a patient using a 7f amplatzer trevisio intravascular delivery system.There was no difficulty experienced using the 7f amplatzer trevisio intravascular delivery system.There was no clinically significant delay in procedure reported.Post--procedure, it was noted that the patient had a right arteriovenous fistula at the access site of the delivery system.On (b)(6) 2024, an ultrasound was performed and revealed persistence of the right arteriovenous fistula.The decision was made to perform a surgical ligation of the right arteriovenous fistula.There is no allegation of malfunction against the abbott device or procedure.The cause of the patient's right arteriovenous fistula is uncertain.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of use of device problem 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, a cause for the reported use of device problem could not be determined.The patient effects of vascular dissection could not determined.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21518116
• Report Number: 2135147-2025-01101
• Device Sequence Number: 18565968
• Product Code: DQY
• UDI-Device Identifier: 05415067030894
• UDI-Public: (01)05415067030894(17)270228(10)10223962
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ATV07F45/60
• Device Lot Number: 10223962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER SEPTAL OCCLUDER, 9-ASD-014 (LOT: 8797810
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 32 KG