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

Catalog Number	9-PLUG-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	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 14mm amplatzer vascular plug was selected for implant on (b)(6) 2024 using a non-abbott delivery system.During the procedure it was acknowledged that use of a vascular plug for a patent ductus arteriosus defect was considered off-label use.The patient was noted to have an unusual pda shape defect.There were no difficulties noted with implanting the device.The physician applied slight tension to the pusher wire prior to device detachment from the delivery system.The device was implanted successfully.On (b)(6) 2024, the device was detected to have migrated and completely dislodged from the implant site.The device was re-captured via transcatheter snare and removed from the patient.The device was replaced with a new amplatzer septal occluder.The physician stated that the migration was not due to the device but the patient anatomy.
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 device migration was reported.Information from field indicated that there were no difficulties noted with implanting the device and the device was implanted successfully.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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.During the procedure it was acknowledged that use of a vascular plug for a patent ductus arteriosus defect was considered off-label use.Please note that per the 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.".
Event or Problem Description
It was reported that a 14mm amplatzer vascular plug was selected for implant on (b)(6) 2024 using a non-abbott delivery system.During the procedure it was acknowledged that use of a vascular plug for a patent ductus arteriosus defect was considered off-label use.The patient was noted to have an unusual pda shape defect.There were no difficulties noted with implanting the device.The physician applied slight tension to the pusher wire prior to device detachment from the delivery system.The device was implanted successfully.On (b)(6) 2024, the device was detected to have migrated.The device was recaptured via transcatheter snare and removed from the patient.The device was replaced with a new atrial septal defect (asd) device.The physician stated that the migration was not due to the device but the patient anatomy.

• Brand Name: AMPLATZER VASCULAR PLUG
• 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: 18652786
• Report Number: 2135147-2024-00526
• Device Sequence Number: 7084211
• Product Code: KRD
• UDI-Device Identifier: 00811806011493
• UDI-Public: 00811806011493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031810
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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-PLUG-014
• Device Lot Number: 8769779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PARENT PLUS 45 (MEDIKIT).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown