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

Catalog Number	9-AVP2-008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, an 8mm amplatzer vascular plug ii was implanted during a ventricular septal defect surgery.On a later date, it was noted that the originally blocked surgical site was found to have blood leakage from the branch of the blood vessel.On (b)(6) 2024, a 6mm amplatzer vascular plug ii was chosen for implant using a non-abbott delivery system.During the procedure, the device was not able to be advanced.On angiography, it appeared that the vessel path was too narrow and curved, making it impossible to reach the target location for placement of the device.The device was removed.Patient was sent to surgery to control the bleeding from the blood vessel and not due to a device malfunction.
Additional Manufacturer Narrative
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) 2023, an 8mm amplatzer vascular plug ii was implanted during a ventricular septal defect surgery.On a later date, it was noted that the originally blocked surgical site was found to have blood leakage from the branch of the blood vessel.On (b)(6) 2024, a 6mm amplatzer vascular plug ii was chosen for implant using a non-abbott delivery system.During the procedure, the device was not able to be advanced.On angiography, it appeared that the vessel path was too narrow and curved, making it impossible to reach the target location for placement of the device.The device was removed.Patient was sent to surgery to control the bleeding from the blood vessel and not due to a device malfunction.
Additional Manufacturer Narrative
It was reported that an 8 mm amplatzer vascular plug ii was implanted during a ventricular septal defect surgery.On a later date, it was noted that the originally blocked surgical site was found to have blood leakage from the branch of the blood vessel.The avp ii device was used off-label for a ventricular septal defect surgery.Please note that, per the instructions for use, "indications and usage: the amplatzer vascular plug and amplatzer vascular plug ii are indicated for arterial and venous embolizations in the peripheral vasculature." the device remains implanted and will not return to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from field indicated that a 6 mm avp ii device was chosen for implant, however the device was not implanted due to difficulty placing the device.Based on available information, the cause of reported blood leak could not be conclusively determined.The patient was sent to surgery to control the bleeding from the blood vessel, and not due to a device malfunction.There were no complaints associated with any other devices from the lot.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: 20346155
• Report Number: 2135147-2024-04829
• Device Sequence Number: 20814905
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: (01)00811806010373(17)261231(10)8307396
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-AVP2-008
• Device Lot Number: 8307396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2022
• 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: 20 YR
• Patient Sex: Male