MAUDE Adverse Event Report: ABBOTT MEDICAL Amplatzer Vascular Plug II; Device, Vascular, For Promoting Embolization

Model Number	9-AVP2-018
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, an 18mm amplatzer vascular plug ii was selected for implant.During device preparation, the device was prepare per ifu, but the cable connection was not checked.During procedure, the plug failed to advance in the delivery catheter at the time of release.The cable connection was not checked prior to attempted deployment.The plug came loose inside the catheter and the entire system was removed together.A new 14mm amplatzer vascular plug ii was successfully implanted.The patient was reported to be in good condition.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of premature separation was reported.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 information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 ; +1(651)756-5400
• MDR Report Key: 21635131
• Report Number: 2135147-2025-01399
• Device Sequence Number: 18014749
• Product Code: KRD
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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 Expiration Date: 05/31/2026
• Device Model Number: 9-AVP2-018
• Device Catalogue Number: 9-AVP2-018
• Device Lot Number: 8033745
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 08/04/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/02/2025; 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• 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: Female