MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG 4; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	9-AVP038-007
Medical Device Problem Codes	Material Deformation (2976); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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)2024, a 7mm amplatzer vascular plug4 was chosen for internal iliac artery (iia) embolization, using a 4f non-abbott delivery catheter.Deployment was attempted by rotating counterclockwise, but the valve was not able to release.The delivery wire was observed to unravel.It is thought that the inner lumen of the contrast catheter may have gotten caught with the delivery wire.The device was removed, and a replacement 8mm amplatzer vascular plug4 was successfully used.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of delivery wire was unravel and plug being unable to be released from the cable was reported.The delivery cable was received for examination the distal end of the outer coil of the cable had become unraveled.The endscrew appeared undamaged.The end screw met specifications, turning a minimum of 6 full turns.An image received appeared to show the push wire unravel.The device was sent for further examination using science & technology (s&t).The fracture face showed evidence of ductile dimples and post fracture wear.Post fracture wear is noticeable by the smooth surface on the fracture face.This can be caused by the material undergoing additional wear and/or stress after the initial break, causing the flat/smooth appearance.The ductile dimples on the fracture face were both circular and oval/oblong in shape.Ductile dimples that are circular in appearance are indicative of tensile forces, whereas ductile dimples that are more oval/oblong in appearance is indicative of torsion forces.This wire was likely exposed to both forces prior to the break.Abbott has initiated additional investigation as a result of this finding.
Event or Problem Description
N/a.

• Brand Name: AMPLATZER VASCULAR PLUG 4
• 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: 18712480
• Report Number: 2135147-2024-00693
• Device Sequence Number: 20874327
• Product Code: KRD
• UDI-Device Identifier: 00811806012377
• UDI-Public: (01)00811806012377(17)261130(10)8251923
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/24/2024

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-AVP038-007
• Device Lot Number: 8251923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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