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

Catalog Number	9-AVP2-006
Medical Device Problem Codes	Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 6mm amplatzer vascular plug ii was chosen for implant using a non-abbott 6f delivery sheath.The patient did not have tortuous anatomy.The plug was difficult to advance into the delivery sheath.The sheath was advanced to the desired deployment site.When the sheath was pulled back to deploy the plug, it was discovered that the plug was not attached to the delivery cable.Under fluoroscopy, it was determined that the plug was lodged in the proximal end of the sheath.The system was removed from the patient.Upon removal, the sheath was replaced, and cannulation was once again obtained.The device was replaced with coils, and the procedure was successfully completed.There was a clinically significant delay in procedure of approximately one hour as multiple sheaths were exchanged in order to deliver the plug.The patient remained hemodynamically stable throughout the procedure and did not experience any adverse events during or after the procedure.The patient was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of difficult to advance (advancement difficulty through delivery system) was and premature separation was reported.The plug was not returned and the delivery system was returned to the lab for analysis.The delivery cable was examined and the end screw was within specification.A test plug was attached to the returned delivery cable, loaded into the returned loader, advanced through the returned system, deployed and retracted without issues.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, the cause for the reported difficult to advance and 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: 21019570
• Report Number: 2135147-2024-06562
• Device Sequence Number: 21121013
• Product Code: KRD
• UDI-Device Identifier: 00811806010366
• UDI-Public: (01)00811806010366(17)260930(10)8182554
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/19/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 9-AVP2-006
• Device Lot Number: 8182554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• 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
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White