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

Model Number	9-AVP2-012
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on a (b)(6) 2025, a mitraclip procedure was performed.4 clips were implanted.On a unknown date post procedure, moderate severe mitral regurgitation remained that was still causing patient symptoms.One of the clips was reported to have reopened (clip opened while locked (cowl).Patient also had a bi-directional shunt from previous transseptal puncture.On (b)(6) 2025, it was decided to implant a 12mm amplatzer vascular plug 2 to reduce the mr utilizing a 7f non-abbott delivery sheath.Gap of planned treatment area was 6x9mm.Sizing determined via transesophageal echocardiogram.The plug was deployed but immediately after release it embolized and traveled to the femoral artery where it was retrieved via snare.The patient experienced no clinical signs or symptoms and there was no blockage of blood flow.A 16mm amplatzer vascular plug 2 was then implanted successfully.It was thought the embolization was due to mis-sizing.
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.The mitraclip system issues mentioned in b5 are captured in separate complaints and are submitted under separate medwatch numbers.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device migration) and off-label use 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 specifications.The investigation determined that the reported device migration appears to be related to mis-sizing.A reported off-label use related to the user used amplatzer vascular plug ii for mitral valve.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product 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 ; 6517565400
• MDR Report Key: 23098053
• Report Number: 2135147-2025-05308
• Device Sequence Number: 18487608
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: (01)00811806010397(17)300331(10)10833923
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/29/2025

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 Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 10833923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 80 KG