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

Model Number	9-ATV09F45/80
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
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) 2025, a 18mm amplatzer septal occluder was selected for implant using a 9f amplatzer trevisio intravascular delivery system.The defect being treated was confirmed to be an atrial septal defect.It was noted that during the preparation outside the body, the occluder transformed into a cobra head.It is reported that the delivery system and the occluder made contact with the patient there was no contact with the intracardiac tissue during deployment or no bend or kink was observed in the delivery sheath.It is noted that deformed device was retrieved before it was released from the delivery cable and there was no harm to the patient.A new replacement 18mm amplatzer septal occluder with 9f amplatzer trevisio intravascular delivery system was used to complete the procedure.It was reported that there was no harm to the patient.
Additional Manufacturer Narrative
An event of poor connection with occluder device was reported.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported event could not be conclusively determined.There were no complaints associated with any other devices from the lot.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) 2025, a 18mm amplatzer septal occluder was selected for implant using a 9f amplatzer trevisio intravascular delivery system.The defect being treated was confirmed to be an atrial septal defect.It was noted that during the preparation outside the body, the occluder transformed into a cobra head.It is reported that the occluder did not make contact with the patient.There was no contact with the intracardiac tissue during deployment or no bend or kink was observed in the delivery sheath.It is noted that deformed device was retrieved before it was released from the delivery cable and there was no harm to the patient.A new replacement 18mm amplatzer septal occluder was chosen for implant and persisted a poor connection with the initially used delivery cable, therefore a new 9f amplatzer trevisio intravascular delivery system was used to complete the procedure.It was reported that there was no harm to the patient.

• 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: 23059849
• Report Number: 2135147-2025-05220
• Device Sequence Number: 9752595
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: (01)05415067030931(17)271031(10)10624836
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 10/28/2025

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-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 10624836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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: 9F AMPLATZER TREVISIO DELIVERY SYSTEM,LOT - 106248
• Patient Sex: Unknown