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

Model Number	9-AVP2-014
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.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 (b)(6) 2025, a 14mm amplatzer vascular plug 2 was chosen for a procedure.The device was implanted.Fifteen minutes after the procedure, it was noted that there was still flow.The plug was explanted and a new 16mm amplatzer vascular plug 2 was chosen and completed the procedure.The physician mentioned the reason for shunt was mis-sizing and there was no additional product experience noted.The patient's final outcome was satisfactory and there was no reported patient effects.The patient was reported recovering.
Event or Problem Description
It was reported that (b)(6) 2025, a 14mm amplatzer vascular plug 2 was chosen for a procedure.The device was implanted.Fifteen minutes after the procedure, it was noted that there was still flow.The plug was explanted and a new 16mm amplatzer vascular plug 2 was chosen and completed the procedure.The physician mentioned the reason for shunt was mis-sizing and there was no additional product experience noted.The patient's final outcome was satisfactory and there was no reported patient effects.The patient was reported recovering.
Additional Manufacturer Narrative
An event of residual shunt was reported.It was mentioned that the reason for shunt was mis-sizing.The device was returned to abbott for investigation and the device met dimensional specifications when analyzed.The device was visually and microscopically examined, and no anomalies were found.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 available information, the cause of the reported residual shunt could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the surgical removal of device.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: 21919947
• Report Number: 2135147-2025-02225
• Device Sequence Number: 9022067
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: (01)00811806010403(17)260131(10)7846635
• 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: 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): 05/20/2025

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 Expiration Date: 01/31/2026
• Device Model Number: 9-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 7846635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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