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

Model Number	9-ATV12F45/80
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report is related to the premature separation that occurred during the procedure.It was reported that on (b)(6) 2023, a 40mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio intravascular delivery system.Prior to the procedure, the septal defect was measured to be 39mm and it was noted that the patient had a complex septum anatomy.The device was attempted to implant in the defect, but difficulty was encountered due to patient anatomy.The device was deployed and recaptured multiple times.During these manipulations, the device detached from the delivery cable and embolized to the right ventricular outflow tract.The device was snared and attempted to recapture into a 16f introducer, but this was unsuccessful.The patient went to emergency surgery, the device was removed, and the septal defect was repaired.The patient was discharged.Related manufacturer reference number: 2135147-2023-00998 related to the embolization of the 40mm amplatzer septal occluder.
Additional Manufacturer Narrative
An event of device detached from the delivery cable was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.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: 17122244
• Report Number: 2135147-2023-02566
• Device Sequence Number: 7388137
• Product Code: DQY
• UDI-Device Identifier: 05415067030955
• UDI-Public: 05415067030955
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/13/2023

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-ATV12F45/80
• 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: 05/18/2023
• Initial Report FDA Received Date: 06/13/2023
• 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
• Patient Age: 41 YR
• Patient Sex: Female