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

Model Number	45-180500
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	07/20/2021
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.The device was implanted in the patient and not returned to the manufacturer for analysis.Procedural or post-procedural imaging was not provided; therefore, the reported event cannot be confirmed.
Event or Problem Description
It was reported that an azur vascular plug was used in a gda embolization case.The plug was deployed without issue and there was stasis at the end of the case.Two weeks after implantation, the patient returned for a follow up and the vessel was no longer occluded.An additional embolization was required two weeks post treatment.There was no reported 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: 12528602
• Report Number: 2032493-2021-00390
• Device Sequence Number: 5159575
• Product Code: KRD
• UDI-Device Identifier: 00842429101612
• UDI-Public: (01)00842429101612(11)200930(17)230831(10)20093011A
• 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): 08/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 45-180500
• Device Lot Number: 20093011A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/24/2021
• 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: Other