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

Model Number	9-ATV08F45/80
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
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 14mm amplatzer septal occluder was selected for implant using an 8f amplatzer trevisio delivery system.During procedure, when deployed in the left atrium (la), the occluder deformed into a cobra shape and the delivery system also deformed.The device was removed from the patient and a new 16mm amplatzer septal occluder was successfully implanted.No patient consequences were reported.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2022, a 14mm amplatzer septal occluder was selected for implant using an 8f amplatzer trevisio delivery system.During procedure, when deployed in the left atrium (la), the occluder deformed into a cobra shape and the delivery system also deformed.The device was removed from the patient and a new 16mm amplatzer septal occluder was successfully implanted.The device was not released inside patient anatomy, there was no angulation or kink noted in the delivery system, and there was no interaction with cardiac structures during deployment.The patient is reported to be recovering.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
An event of device and delivery system deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported event could not be conclusively determined.

• 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: 15777711
• Report Number: 2135147-2022-02035
• Device Sequence Number: 15103484
• Product Code: DQY
• UDI-Device Identifier: 05415067030924
• UDI-Public: 05415067030924
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 01/23/2023

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: 03/31/2025
• Device Model Number: 9-ATV08F45/80
• Device Catalogue Number: 9-ATV08F45/80
• Device Lot Number: 8450039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER SEPTAL OCCLUDER, 9-ASD-014; AMPLATZER TREVISIO DS, 9-ATV08F45/80
• Patient Age: 17 YR
• Patient Sex: Female