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

Model Number	9-AVP2-014
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	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Na.The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 23mm navitor vision valve was chosen for implant using an unknown delivery system.The patient had a non-abbott surgical aortic valve was implanted in 2012 and 23mm portico valve was implanted in the non-abbott valve on an unknown date in 2020.On an unknown date, the patient presented with worsening dyspnea and a valve failure was noted.During procedure, the case went as planned and the valve was successfully implanted.A small leak was noted after implant and a post dilatation balloon was requested to achieve optimal apposition of the implant.A valve fracture of the surgical valve performed and the surgical valve fractured.An aortogram was performed after valve fracture showed a ventricular septal defect (vsd) was evident and a unknown size amplatzer vascular plug ii (avp2) was chosen to close vsd.The avp2 plug closed the vsd but was not secure.A new 25mm navitor vision was implanted and that sandwiched the plug to secure it.The vsd remained closed and patient remained hemodynamically stable.The patient had a conduction disturbance following the procedure and a temporary pacing wire was left in the original place.On (b)(6) 2024, the patient received a permanent pacemaker.The patient was reported stable and discharged.
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 was unable to determine the cause of the reported device migration.A reported off-label use related to the user used amplatzer vascular plug ii for ventricular septal defect (vsd).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.Per the instructions for use, amplatzer vascular plug ii, "intended use: the amplatzer¿ vascular plug ii is indicated for arterial and venous embolization's in the peripheral vasculature." this is considered as an off-label use of the device.However, it was unable to determine if the off-label use contributed to the reported incident.Therefore, a letter will not be sent out to the accountant.

• 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: 21910838
• Report Number: 2135147-2025-02190
• Device Sequence Number: 9390257
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: (01)00811806010403(17)281231(10)10163551
• 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
• 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): 07/21/2025

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-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 10163551
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male