MAUDE Adverse Event Report: MICROVENTION, INC. WEB SLS; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W2-8-3-MVI-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Extravasation (1842)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance's 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 evaluation.Procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.The ifu identifies aneurysm perforation or rupture as a potential complication associated with use of the device.The device associated with this event was used during the same procedure referenced in mfr.Report # 2032493-2021-00244.

Event Description

It was reported that during treatment of an aneurysm, a via microcatehter and web device were advanced into position when an angiographic run revealed extravasation.It was not known if the web or the via caused the extravasation.Heparin was reversed and the next angiographic run revealed no further extravasation.The web was impeding flow in the parent vessel.A competitor's stent was placed in order to keep the web device in the aneurysm.Flow through the stent shut down and integrillin was administered, which restored flow.Post procedure, the patient was awake, following commands and moving their right and left legs.There was no reported sequelae.

• Brand Name: WEB SLS
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12029395
• MDR Text Key: 258385245
• Report Number: 2032493-2021-00243
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429107140
• UDI-Public: (01)00842429107140(11)210125(17)251231(10)210125111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-8-3-MVI-3
• Device Catalogue Number: W2-8-3
• Device Lot Number: 210125111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention