MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP2-014
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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Event or Problem Description
It was reported that on (b)(6) 2026, a 14mm amplatzer vascular plug 2 was chosen for implant using unknown delivery system.The device was selected during a two-debranch thoracic endovascular aortic repair (tevar) procedure for subclavian artery embolization.During advancement of the avp2 through the sheath, detachment of the pusher wire from the distal mesh occurred within the sheath.As retrieval from within the sheath was difficult, the entire sheath was removed from the patient, and the system was retrieved outside the body.The sheath was subsequently reinserted, and a new 14mm avp2 was opened and prepared.The newly opened device was delivered to the target site without issue and was successfully implanted.The physician was informed of the event and confirmed that no rotation was applied during preparation or delivery, in accordance with the instructions for use, and that all preparatory steps, including flushing, were properly performed.A possible cause considered was unintended rotation of the pusher wire or the loader portion at some point prior to or during insertion or advancement through the sheath, which may have led to detachment; however, there is also a possibility that the connection was loose at the time of package opening or that a device defect was present.The detached system was fully removed and retrieved outside the body, and there was no impact on the patient.
Event or Problem Description
It was reported that on (b)(6) 2026, a 14mm amplatzer vascular plug 2 was chosen for implant using non-abbott delivery system.The device was selected during a two-debranch thoracic endovascular aortic repair (tevar) procedure for subclavian artery embolization.During advancement of the avp2 through the sheath, a complete detachment of the pusher wire from the distal mesh occurred within the sheath.The system was manipulated in the usual manner, and delivery to the target lesion was attempted using the pusher wire.As retrieval from within the sheath was difficult, the entire sheath was removed from the patient, and the system was retrieved outside the body.There was no contact between the detached device and the patient¿s body.The sheath was subsequently reinserted, and a new 14mm avp2 was opened and prepared.The newly opened device was delivered to the target site without issue and was successfully implanted.The physician was informed of the event and confirmed that no rotation was applied during preparation or delivery, in accordance with the instructions for use, and that all preparatory steps, including flushing, were properly performed.A possible cause considered was unintended rotation of the pusher wire or the loader portion at some point prior to or during insertion or advancement through the sheath, which may have led to detachment; however, there is also a possibility that the connection was loose at the time of package opening or that a device defect was present.The detached system was fully removed and retrieved outside the body, and there was no impact on the patient.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of a premature separation of the plug and delivery cable was reported.The device was returned to abbott for investigation and the plug and delivery cable met functional specifications when analyzed under non-physiological conditions.However, the screw from the vise was attempted to be inserted into the vise and was unable to be fully screwed in.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported premature separation could not be determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 24780449
• Report Number: 2135147-2026-02160
• Device Sequence Number: 21313685
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: (01)00811806010403(17)300831(10)11058636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 05/22/2026

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 Model Number: 9-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 11058636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 05/15/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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: Unknown