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

Catalog Number	9-ATV12F45/80
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 04 january 2024, a 36mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio intravascular delivery system.During procedure, the device had a cobra deformation after full deployment.The left disc opened well, but the right disc could not open and formed a cobra shape.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment.When the implanter tried to pull in the device and retrieve the sheath, the left disc was not able re-sheath.The implanter used great force to pull device into sheath, with the distal part still partially exposed outside the sheath while removing the whole system.This caused a tear in the femoral vein, but no major bleeding occurred.Upon inspection, the delivery system had crumbled due to the force used to retract the device.A new 34mm amplatzer septal occluder was chosen and successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient was reported stable.
Additional Manufacturer Narrative
An event of retraction difficulty and a delivery system crumbling was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that the delivery system had crumbled due to the force used to retract the device.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 18596627
• Report Number: 2135147-2024-00393
• Device Sequence Number: 15484907
• Product Code: DQY
• UDI-Device Identifier: 05415067030955
• UDI-Public: 05415067030955
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 01/29/2024

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 Catalogue Number: 9-ATV12F45/80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 8 YR
• Patient Sex: Female