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

Model Number	9-ATV10F45/80
Medical Device Problem Codes	Material Invagination (1336); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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 on (b)(6) 2025 an amplatzer septal occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.During the procedure the occluder was deployed.An attempt was made to partially re-sheath the occluder, however it was noted that the occluder could not be re-sheathed.The occluder and delivery system were removed from the patient and inspected.It was noted that the tip of the delivery system was enfolded into itself.The procedure was aborted and the decision was made to refer the patient to surgery on a future date.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of retraction problem, inverted sheath tip was reported.A returned device assessment could not be performed as the device was not returned for analysis.During implant, the 26mm amplatzer septal occluder was attempted to be retrieved back into the delivery sheath, however this was unsuccessful.It was noted that the tip of the delivery system was enfolded into itself.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 appears to be due to inverted sheath tip.However, the cause of the reported inverted sheath tip 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
It was reported on (b)(6) 2025 an amplatzer septal occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.During the procedure the occluder was deployed.An attempt was made to partially re-sheath the occluder, however it was noted that the occluder could not be re-sheathed.The occluder and delivery system were removed from the patient and inspected.It was noted that the tip of the delivery system was enfolded into itself.The procedure was aborted and the decision was made to refer the patient to surgery on a future date.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of retraction problem, inverted sheath tip was reported.A returned device assessment could not be performed as the device was not returned for analysis.During implant, the 26mm amplatzer septal occluder was attempted to be retrieved back into the delivery sheath, however this was unsuccessful.It was noted that the tip of the delivery system was enfolded into itself.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 appears to be due to inverted sheath tip.The cause of the reported inverted sheath tip could not be conclusively determined.The possible cause could be due to the damage during the use.However, this cannot be confirmed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: type of investigation: 4114.

• 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: 22080313
• Report Number: 2135147-2025-02753
• Device Sequence Number: 13137024
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: (01)05415067030948(17)270331(10)10274441
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 05/15/2026

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-ATV10F45/80
• Device Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 10274441
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 08/09/2025; 03/09/2026; 05/06/2026
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/18/2025; 03/31/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26MM AMPLATZER SEPTAL OCC [9-ASD-026, LOT: 8952392].
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 25 KG