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

Model Number	9-AVP2-012
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	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User facility medwatch report (b)(4) received that states "the plug kept twisting and twisting.It would not unscrew".It was reported that on (b)(6) 2025, a 12mm amplatzer vascular plug 2 was chosen for a procedure.During procedure, it was noted that the plug kept twisting and twisting and it would not unscrew.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event for separation problem and difficult to fold, unfold, or collapse (twisted plug) 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.The investigation was unable to determine the cause for the reported separation problem (unscrew) and difficult to fold, unfold, or collapse (twisted plug).There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
User facility medwatch report (b)(4) received that states "the plug kept twisting and twisting.It would not unscrew".It was reported that on (b)(6) 2025, a 12mm amplatzer vascular plug 2 was chosen for a procedure.During procedure, it was noted that the plug kept twisting and twisting and it would not unscrew.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported discharged.

• 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: 22898546
• Report Number: 2135147-2025-04797
• Device Sequence Number: 12985860
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: (01)00811806010397(17)300331(10)10841491
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Study,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 10841491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 05/14/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/23/2025; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2025
• 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
• Patient Sex: Unknown