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

Model Number	9-ATV09F45/80
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 16mm amplatzer septal occluder was chosen for implant, using 09f amplatzer trevisio intravascular delivery system.During deployment of the device, the left atrial disk deformed.The device was recaptured and removed.The tip of the delivery system was noted to be deformed.A replacement 09f amplatzer trevisio intravascular delivery system and occluder were used to complete the procedure.The device was successfully deployed.There were no adverse patient effects.
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) 2023, a 16mm amplatzer septal occluder was chosen for implant, using 09f amplatzer trevisio intravascular delivery system.During deployment of the device, the left atrial disk deformed to a bulbous shape.There was no angulation or kink noticed in the delivery system.There was interaction with cardiac structures during deployment.The device was recaptured and removed.When the delivery system was removed from anatomy, the tip of the delivery system was noted to be frayed.A replacement 09f amplatzer trevisio intravascular delivery system and occluder were used to complete the procedure.The device was successfully deployed.There were no adverse patient effects.
Additional Manufacturer Narrative
It was reported that the delivery system tip was noted to be frayed after use in the patient.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.The cause of the reported incident could not be conclusively determined, however, as the damage to the delivery system was reported to be noted after it was removed from the patient it could be due to damage during use.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17342287
• Report Number: 2135147-2023-03072
• Device Sequence Number: 20476263
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: 05415067030931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/10/2023

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: 02/28/2025
• Device Model Number: 9-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 8392447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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 TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Patient Sex: Unknown