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	06/06/2023
Type of Reportable Event	Serious Injury
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 8mm amplatzer vascular plug iv was selected for an implant.During the procedure, the vessel diameter 6.02mm under computed tomography angiography measurement.The device was successfully deployed but was unable to achieved occlusion after 19min of waiting.The physician alleged that patient vessel problem, as patient has mycotic aneurysm of iia was the cause for the device not to archived occlusion.A non-abbott device was implant to achieve occlusion.Patient status is unknown.
Additional Manufacturer Narrative
An event of the plug not occluding the vessel it was placed in was reported.A returned device assessment could not be performed as the device remains implanted and 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 all specifications.Information from the field indicated that the physician thought the patient vessel contributed to the event, as patient had mycotic aneurysm of iia.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17267188
• Report Number: 2135147-2023-02901
• Device Sequence Number: 8061576
• Product Code: KRD
• UDI-Device Identifier: 00811806012384
• UDI-Public: 00811806012384
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/29/2023

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 Model Number: VASCULAR PLUG 4
• Device Catalogue Number: 9-AVP038-008
• Device Lot Number: 8644674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown