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	06/26/2021
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 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 treat gda bleed.The plug was deployed without issue but then migrated into an accessory branch.Embolization coil implants were utilized to embolize the gda.Angiography revealed that the avp had migrated to the hepatic artery.A snare was used to retrieve the plug, but it was ultimately unsuccessful.The plug was left in the hepatic artery, which still had flow, oriented in a "north-south" position.

• 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: 12222189
• Report Number: 2032493-2021-00293
• Device Sequence Number: 4507912
• Product Code: KRD
• UDI-Device Identifier: 00842429101629
• UDI-Public: (01)00842429101629(11)200930(17)230831(10)20093011E
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/26/2021

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: 45-180800
• Device Lot Number: 20093011E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 88