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

Model Number	9-ATV07F45/80
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, an amplatzer septal occluder was chosen for implant using a 7f amplatzer trevisio intravascular delivery system.During procedure, the physician deployed both discs across the interatrial communication.A recapture was necessary, but the prosthesis did not enter the sheath even under traction.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Additional Manufacturer Narrative
An event of retraction problem was reported.A returned device assessment could not be performed as the device was not returned for analysis.During implant, a amplatzer septal occluder was attempted to be retrieved back into the delivery sheath, however this was unsuccessful.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, and with out the device to analyze, the cause of the reported retraction problem 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 or Problem Description
N/a.
Additional Manufacturer Narrative
An event of retraction problem was reported.A returned device assessment could not be performed as the sheath was noted to have a bent damage along with a invaded tip.No anomalies were found on the returned components.Due to the tip damage on the sheath, functional testing was precluded.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 retraction problem 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 or Problem Description
N/a.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• 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: 22591663
• Report Number: 2135147-2025-04067
• Device Sequence Number: 9128894
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• UDI-Public: (01)05415067030900(17)270930(10)10545168
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-ATV07F45/80
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 10545168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 09/26/2025; 10/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/01/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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
• Patient Sex: Female