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

Model Number	45-181000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a partial splenic embolization coil, an azur vascular plug was implanted.Eight minutes after implantation, the plug was observed to have moved 1-2 cm from the original position.The case with successfully completed.
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.Although the device was implanted in the patient, images were provided for analysis.The investigation is currently ongoing.
Additional Manufacturer Narrative
No product(s) were returned for evaluation, but two images were provided.The first image shows the two radiopaque markers of the azur vascular plug in the mid-portion of the splenic artery.The second image shows that the plug markers have migrated distally approximately 2 cm.These images confirm the complaint and show the plug migrated distal to the original deployment.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.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13665098
• Report Number: 2032493-2022-00078
• Device Sequence Number: 12081148
• Product Code: KRD
• UDI-Device Identifier: 00842429101636
• UDI-Public: (01)00842429101636(11)211026(17)240930(10)0000090107
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/03/2022

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: 09/30/2024
• Device Model Number: 45-181000
• Device Lot Number: 0000090107
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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
• Patient Sex: Unknown