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

Catalog Number	9-AVP2-004
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	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, a 4mm amplatzer vascular plug ii was selected for an implant.During the procedure, a non-abbott delivery catheter were in place.The plug was implanted, and the leak was observed 3 minutes later.The contrast agent still passes through the target vessel due to poor adherence.The size of the vessel plug is not suitable for the shape of the arterial duct.So the physician replaced with a non-abbott device to complete the procedure.The patient was stable, no clinically significant delay in the procedure.
Additional Manufacturer Narrative
An event of leak was reported.The investigation confirmed the device met dimensional and visual specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that, per instructions for use, "warnings: the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.".

• 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: 18322634
• Report Number: 2135147-2023-05488
• Device Sequence Number: 7358715
• Product Code: KRD
• UDI-Device Identifier: 00811806010359
• UDI-Public: 00811806010359
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/16/2024

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 Catalogue Number: 9-AVP2-004
• Device Lot Number: 8916651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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 Sex: Unknown