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

Model Number	VASCULAR PLUG 4
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023 a 8mm amplatzer vascular plug iv was selected for an implant in a patient with an irregular defect, which has the largest diameter of 4mm.At the beginning of the procedure, the 5f non-abbott delivery catheter was in place and the device was successfully implanted.Approximately 3 minutes post implant the device did not embolize the defect; the contrast agent was still passing through the target vessel due to poor adherence.The plug was retrieved via snare and a non-abbott device was successfully implanted to complete the procedure.It was reported that there was a clinically significant delay in the procedure.The patient was reported to be in stable condition.
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 did not embolize the defect" was reported.The investigation confirmed that the device met visual and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.The cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
An event of "device did not embolize the defect" was reported.The investigation confirmed that the device met visual and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.The cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2023 a 8mm amplatzer vascular plug iv was selected for an implant in a patient with an irregular defect, which has the largest diameter of 4mm.At the beginning of the procedure, the 5f non-abbott delivery catheter was in place and the device was successfully implanted.Approximately 3 minutes post implant the device did not embolize the defect; the contrast agent was still passing through the target vessel due to poor adherence.The plug was retrieved via snare and a non-abbott device was successfully implanted to complete the procedure.It was reported that there was a clinically significant delay in the procedure.The patient was reported to be in stable condition.

• 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: 16556511
• Report Number: 2135147-2023-01219
• Device Sequence Number: 20068021
• Product Code: KRD
• UDI-Device Identifier: 00811806012384
• UDI-Public: 00811806012384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113658
• 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,Followup
• Report Date (Section B): 02/12/2024

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 Expiration Date: 04/30/2026
• Device Model Number: VASCULAR PLUG 4
• Device Catalogue Number: 9-AVP038-008
• Device Lot Number: 7959114
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 01/18/2024
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/19/2023; 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown