MAUDE Adverse Event Report: MICROVENTION, INC. VASCULAR PLUG 18; VASCULAR EMBOLIZATION DEVICE

Model Number	45-180800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.No product(s) were returned for evaluation, but two images were provided.The first image appears to show a deployed azur vascular plug with contrast passing across the device in the treated vessel.The second image shows a deployed azur vascular plug device with no contrast flowing across the implanted device.These images confirm the complaint and show recanalization of previously embolized vessel.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The instructions for use (ifu) identifies incomplete filling as potential complications associated with use of the device.
Event or Problem Description
It was reported that the physician placed an 8mm azur vascular plug in the gastroduodenal artery (gda).When the patient returned 10 days later for a y-90 treatment, it was found that the gda was not occluded.Coils were used to occlude the gda and the y-90 treatment was completed.There was no report of harm or injury to the patient.

• Brand Name: VASCULAR PLUG 18
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12543237
• Report Number: 2032493-2021-00392
• Device Sequence Number: 17141558
• Product Code: KRD
• UDI-Device Identifier: 00842429101629
• UDI-Public: (01)00842429101629(11)210217(17)240131(10)21021716A
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 45-180800
• Device Lot Number: 21021716A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention