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

Model Number	9-ITV08F180/80
Medical Device Problem Codes	Retraction Problem (1536); Device Damaged by Another Device (2915); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6)2023, an 8mm amplatzer muscular vsd occluder was chosen for implant via femoral vein appoach with a 6f amplatzer torqvue delivery system.During deployment, the 8mm device appeared too small and the deployment angle was not ideal so the 8mm device was replaced prior to release while inside the patient.A 10mm amplatzer muscular vsd occluder was then chosen for implant with the same 6f amplatzer torqvue delivery system.During deployment, the 10mm occluder also appeared too small and the deployment angle was also not ideal.A decision was made to replace both the 10mm occluder and 6f delivery system.It was then reported a 12mm amplatzer muscular vsd occluder was chosen for implant via internal jugular approach with a 7f amplatzer torqvue delivery system.During deployment, the 12mm occluder was not able to be released from the delivery cable.Both 12mm occluder and 7f delivery system were removed from the patient and the 12mm occluder was removed from the delivery cable without difficulty.A decision was made to implant the same 12mm occluder with an 8f amplatzer torqvue delivery system.During deployment, due to the deployment angle not being ideal, the 12mm occluder was deployed obliquely on the septum and was not stable.A decision was made to recapture the device when the tip of the 8f delivery system became kinked due to the angle of the device on the septum and resulted in a failed recaptured attempt.A 9f amplatzer torqvue exchange system was then used to successfully remove the 12mm occluder.Due to the clinically significant delay in procedure, a decision was made to abort the procedure.It was reported the patient's defect measurements were 10x6mm at pre-procedure via transthoracic echocardiography (tte) and 7x5mm at post-procedure via tte.It was reported the patient did not have tortuous anatomy but was noted that due to the size of patient, the chambers were smaller and more difficult to navigate due to narrow angles to traverse from one access point to the defect.The patient remained hemodynamically stable throughout the procedure.There was no report of any adverse patient consequences.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of kink in delivery system due to the angle of the device on the septum resulting in difficulty recapturing the device was reported.The device was returned to abbott for investigation and the was found to be kinked and tip of sheath was inverted when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported incident could not be conclusively determined, however the damage is consistent with damage during use.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TORQVUE 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: 16998318
• Report Number: 2135147-2023-02308
• Device Sequence Number: 2452919
• Product Code: DQY
• UDI-Device Identifier: 00811806010823
• UDI-Public: 00811806010823
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072313
• 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): 07/10/2023

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: 09/30/2025
• Device Model Number: 9-ITV08F180/80
• Device Catalogue Number: 9-ITV08F180/80
• Device Lot Number: 8714463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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 MUSCULAR VSD OCCLUDER, 9-VSD-MUSC-012
• Patient Age: 22 MO
• Patient Sex: Male