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	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during embolization treatment of the splenic artery, an azur vascular plug (avp) encountered advancement issues but was eventually deployed.Immediately following deployment, the device migrated distally to a vessel close to the spleen.Another avp was successfully used.There was no reported patient injury.
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issuesrelevant to the complaint that occurred during manufacturing of the device.Procedural or post-procedural imaging was not provided; therefore, the reported event cannot be confirmed.
Event or Problem Description
It was reported that during embolization treatment of the splenic artery, an azur vascular plug (avp) encountered advancement issues but was eventually deployed.Immediately following deployment, the device migrated distally to a vessel close to the spleen.Another avp was successfully used.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information provided clarified that the avp was deployed after the large azur plug migrated towards the spleen and lodged in the unintended 4mm vessel, close to the spleen.The azur plug was not retrieved and was left in the patient.The avp was deployed and implanted in the intended 6.2mm vessel.No patient harm was reported.

• Brand Name: VASCULAR PLUG 18
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 14383305
• Report Number: 2032493-2022-00199
• Device Sequence Number: 12469451
• Product Code: KRD
• UDI-Device Identifier: 00842429101636
• UDI-Public: (01)00842429101636(11)211027(17)240930(10)0000090109
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K191680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 09/30/2024
• Device Model Number: 45-180800
• Device Lot Number: 0000090109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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; Disability
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 86 KG