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

Model Number	9-AVP2-008
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, two 8mm amplatzer vascular plug ii devices were selected for the pda procedure and prepared in accordance with the instruction for use (ifu).Each device was inspected during the preparation to the procedure, and no abnormalities observed.However, during the procedure, both devices could not be unscrewed.No holes were observed in the mesh prior to insertion into the patient anatomy.Upon removal, one device (8mm amplatzer vascular plug ii lot # 10281568) was found to have a hole in the center of its body.Neither of the complaint devices was implanted.There were no differences in how the two devices were handled or used prior to their return to the manufacturer.The patient exhibited no clinical signs or symptoms during or after the event.There was no clinically significant delay in the procedure, and no adverse patient effects were reported.
Additional Manufacturer Narrative
The reported separation failure could not be confirmed.Upon inspection, the returned device showed no anomalies, and was able to attach and detach easily 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 specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Correction: upon review, the 9-avp2-008 should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.Codes removed: medical device problem code: 1254 difficult to fold, unfold or collapse.
Event or Problem Description
It was reported that on (b)(6) 2025, two 8mm amplatzer vascular plug ii devices were selected for the pda procedure and prepared in accordance with the instruction for use (ifu).Each device was inspected during the preparation to the procedure, and no abnormalities observed.However, during the procedure, both devices could not be unscrewed as expected.No holes were observed in the mesh prior to insertion into the patient anatomy.Upon removal, one device (8mm amplatzer vascular plug ii lot # 10281568) was found to have a hole in the center of its body.Neither of the complaint devices was implanted.There were no differences in how the two devices were handled or used prior to their return to the manufacturer.The patient exhibited no clinical signs or symptoms during or after the event.There was no clinically significant delay in the procedure, and no adverse patient effects were reported.

• 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: 22877841
• Report Number: 2135147-2025-04737
• Device Sequence Number: 5689632
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: (01)00811806010373(17)290331(10)10281568
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• 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): 10/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-008
• Device Catalogue Number: 9-AVP2-008
• Device Lot Number: 10281568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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
• Patient Sex: Unknown