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

Model Number	45-180800
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
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 to occlude a patient's splenic artery.The vascular plug migrated slightly downstream, which the physician was "okay" with as they intended on occluding the entire artery.The artery still had flow so the occlusion was completed with coils.There was no reported patient injury.

• 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: 12241480
• Report Number: 2032493-2021-00294
• Device Sequence Number: 17095762
• Product Code: KRD
• UDI-Device Identifier: 00842429101629
• UDI-Public: (01)00842429101629(11)201123(17)231031(10)20112311X
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 45-180800
• Device Lot Number: 20112311X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1