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

Catalog Number	9-AVP2-008
Medical Device Problem Codes	Off-Label Use (1494); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a 8mm amplatzer vascular plug ii (avpii) lot: 8715833 was chosen for implantation to treat a perivalvular leak utilizing a non-abbott delivery system.The device was prepared without issue.When placing the device, contrast agent was flowing out so the device was removed from the patient.Outside of the patient a large hole was observed in the device on the edge of the middle lobe of nitinol mesh.A replacement 8mm avpii was used to complete the procedure with the same delivery system.There were no patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.
Additional Manufacturer Narrative
¿ investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of hole was observed on the middle lobe of nitinol mesh and off-label use were reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The plug revealed one small hole in the side of the device waist.The hole is considered a normal and acceptable characteristic of the device.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 available information, a cause for the reported event could not be determined.However, a reported off-label use related to the user used amplatzer vascular plug ii for perivalvular leak.There is no indication of a product issue with respect to manufacture, design or labeling.Per the instructions for use, amplatzer vascular plug ii, stated "intended use: the amplatzer¿ vascular plug ii is indicated for arterial and venous embolization's in the peripheral vasculature.".

• 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: 19130303
• Report Number: 2135147-2024-01734
• Device Sequence Number: 6853963
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: (01)00811806010373(17)270930(10)8715833
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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-AVP2-008
• Device Lot Number: 8715833
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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
• Patient Sex: Unknown