MAUDE Adverse Event Report: MICROVENTION, INC. AZUR VASCULAR PLUG 8; VASCULAR EMBOLIZATION DEVICE

Model Number	45-181000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains implanted in the patient and procedure images were not provided; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies implant migration as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an embolization procedure the azur vascular plug was placed in the proximal splenic artery just distal to a 3cm aneurysm.After about 5 minutes of elapsed time, the plug migrated forward to the distal splenic artery.Additional coils were placed in the proximal splenic artery and occlusion was achieved.The splenic artery measured 7mm on cta.There was no report of harm or injury to the patient.The product reported in this report is an exported device not cleared or approved for marketing in the u.S.The complaint is being reported based on this product meeting similar product criteria.
Additional Manufacturer Narrative
Correction: the statement provided in section b5 in initial mdr incorrectly indicated (the product reported in this report is an exported device not cleared or approved for marketing in the u.S.The complaint is being reported based on this product meeting similar product criteria).The azur vascular plug device is an approved device in the us under 510(k) number: k191680 as was indicated in section g4 in initial mdr.Therefore, the similar device reporting category is no applicable in this event.

• Brand Name: AZUR VASCULAR PLUG 8
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13939899
• Report Number: 2032493-2022-00118
• Device Sequence Number: 6581372
• Product Code: KRD
• UDI-Device Identifier: 00842429101636
• UDI-Public: (01)00842429101636(11)211025(17)240930(10)0000090106
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 45-181000
• Device Lot Number: 0000090106
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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
• Patient Sex: Unknown