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

Model Number	9-AVP2-010
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a 10mm amplatzer vascular plug ii was selected for implant.All steps were performed per instructions for use (ifu).During the procedure the plug was partially re-captured three times.The plug was unable to release from the delivery cable.After unscrewing the plug, the plug embolized to the left atrium.The plug was surgically removed from the patient.The patient remained hemodynamically stable throughout the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 a 10mm amplatzer vascular plug ii was selected for implant.All steps were performed per instructions for use (ifu).During the procedure the plug was partially re-captured three times.The plug was unable to release from the delivery cable.After unscrewing the plug, the plug embolized to the left atrium.The plug was surgically removed from the patient.The patient remained hemodynamically stable throughout the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
An event of an event of a separation problem and device embolization 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 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 separation problem and device embolization could not be determined.A surgical intervention was a result of case specific circumstances, as the device was surgically removed.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: 23681931
• Report Number: 2135147-2025-07034
• Device Sequence Number: 9807976
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: (01)00811806010380(17)290831(10)10524659
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/12/2026

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-AVP2-010
• Device Catalogue Number: 9-AVP2-010
• Device Lot Number: 10524659
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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 Age: 80 YR
• Patient Sex: Male