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

Catalog 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	08/09/2023
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) 2023 a 22mm amplatzer septal occluder was chosen for implantation into an atrial septal defect (asd) utilizing an amplatzer trevisio delivery system.The defect was measured as 18mm using transesophageal echocardiogram (tee).When attempting to implant the device, the left disc formed a cobra head deformity.The device was recaptured and attempted to be implanted again, but the cobra head deformity continued.The device was attempted to be recaptured but in the process detached from the delivery system.The occluder traveled to the ascending aorta and caused a partial obstruction of blood flow.The device could not be snared so the patient was transferred to open surgery immediately to retrieve the device.The patient was reported to have prolonged hospitalization due to open heart surgery recovery.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.
Additional Manufacturer Narrative
An event of a device detaching from a delivery cable and deploying prematurely in the ascending aorta and caused a partial obstruction of blood flow 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.An image was received from the field and the image appears to show the device deformity.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 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: 17669725
• Report Number: 2135147-2023-03820
• Device Sequence Number: 12538884
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: 05415067030948
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 10/04/2023

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: 01/31/2026
• Device Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 8887992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2023
• 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-022; AMPLATZER TREVISIO DS 9-ATV10F45/80, LOT: 8887992
• Patient Sex: Unknown