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

Model Number	9-ATV10F45/80
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
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) 2022, a 10f amplatzer trevisio intravascular delivery system was selected for use to implant an unknown device.It was noted during procedure that the unknown device prematurely detached from the delivery cable.The decision was made to snare the unknown device using a goose neck snare.The 10f amplatzer trevisio intravascular delivery system was replaced and the same unknown device was deployed using the new delivery cable.There were no adverse patient consequences reported.The patient was stable at the time of report.
Additional Manufacturer Narrative
An event of the occluder detaching prematurely was reported.The investigation found that the balloon met functional specifications when analyzed at abbott under non-physiological conditions.Information from the field indicated the cable was not rotated as it was advanced through the patient's anatomy.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2022, a 10f amplatzer trevisio intravascular delivery system was selected for implant of an unknown device for an atrial septal defect closure.It was noted during procedure that the unknown device prematurely detached from the delivery cable inside the left atrium.This was confirmed by transesophageal echocardiogram (tee) and fluoroscopy.The decision was made to snare the unknown device using a goose neck snare.The 10f amplatzer trevisio intravascular delivery system was replaced and the same unknown device was deployed using the new delivery cable.The delay was clinically significant, but low risk.The patient did not have tortuous anatomy.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient consequences reported.The patient was stable at the time of report.Subsequent to the previously filed report, additional information was received that the device was used for an atrial septal defect closure.It was noted during procedure that the unknown device prematurely detached from the delivery cable inside the left atrium.This was confirmed by transesophageal echocardiogram (tee) and fluoroscopy.The delay was clinically significant, but low risk.The patient did not have tortuous anatomy.The patient remained hemodynamically stable throughout the procedure.

• Brand Name: AMPLATZER TREVISIO
• 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: 15854818
• Report Number: 2135147-2022-02207
• Device Sequence Number: 5202296
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: 05415067030948
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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 Expiration Date: 01/31/2025
• Device Model Number: 9-ATV10F45/80
• Device Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 8326707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2022
• 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