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

Model Number	9-AVP2-016
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 16mm amplatzer vascular plug ii was chosen for implant using an non-abbott delivery system.Following deployment and release of the device, the physician observed that residual blood flow continued to pass through the treated vessel.The leak was observed as a paravalvular leak and measured 1.2mm.The leak was observed through x-ray and cardiac ultrasound.The procedure was stopped, and the damage was reported.The physician subsequently removed the device using the delivery system to complete the procedure.The procedure was completed, and the patient¿s final outcome was reported as satisfactory with no adverse effects.It was confirmed that the device was released from the delivery system.There were no clinical signs or symptoms during or after this event.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of residual shunt 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 incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4641.
Event or Problem Description
It was reported that on (b)(6) 2026, a 16mm amplatzer vascular plug ii was chosen for implant using an non-abbott delivery system.Following deployment and release of the device, the physician observed that residual blood flow continued to pass through the treated vessel.The leak was observed as a paravalvular leak and measured 1.2mm.The leak was observed through x-ray and cardiac ultrasound.The procedure was stopped, and the damage was reported.The physician subsequently removed the device using the delivery system to complete the procedure.It was confirmed later that the device was not released from the delivery system.The physician tried to rotate the guide wire (delivery cable) to released the device from the delivery system, but he saw the device rotated with the guide wire.So, he decided to change other new one to finish the operation.The procedure was completed, and the patient¿s final outcome was reported as satisfactory with no adverse effects.It was confirmed that the device was released from the delivery system.There were no clinical signs or symptoms during or after this event.

• 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: 24283599
• Report Number: 2135147-2026-00725
• Device Sequence Number: 13252466
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: (01)00811806010410(17)300731(10)10983714
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-016
• Device Catalogue Number: 9-AVP2-016
• Device Lot Number: 10983714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown