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

Model Number W5-5-2-MVI-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Paresis (1998); Stenosis (2263); Obstruction/Occlusion (2422)

Event Type  malfunction  

Event Description

It was reported through article titled, "bailout strategies for abrupt changing of the woven endobridge-17 web-17 device orientation after detachments: technical note of 2 anterior communicating artery aneurysm cases" , that a patient was being treated for an anterior communicating artery aneurysm with a web-17, and post implantation, movement of the web 17 sl occurred, resulting in blockage of the parent vessel, requiring intervention of medication and rescue stenting.A patient with a medical history of prior stroke with residual baseline left-sided weakness, presented to an outside hospital for evaluation of new stroke-like symptoms.The patient underwent stroke work-up and ct angiography which demonstrated an irregular multilobulated 5.3 x 4 mm acom aneurysm.The decision was made to proceed with web embolization.A web-sl 17 device (4 x 4 mm) was deployed with multiple runs demonstrating good positioning of the device inside the aneurysmal sac.Immediately at detachment of the device and its release from the delivery wire, the device abruptly angled and prolapsed from the sac, migrating into the right anterior cerebral artery (aca), and moved further into the distal right aca at the level of the pericallosal and callosomarginal bifurcation.The groin sheath was exchanged for a 6 fr bmx catheter which was positioned into the distal ica.Next, the sofia aspiration catheter was brought up to the level of the device, with multiple unsuccessful attempts of retrieving the device.The device could not be engaged and therefore, the decision was made to stent the device in place at the level of the pericallosal artery bifurcation.The patient was loaded with eptifibatide and 2 neuroform atlas stents were deployed in a y-construct (both 3x15 mm) within the callosomarginal and pericallosal arteries.Subsequent angiography demonstrated patent parent arteries with a mild stenosis at the web device level secondary to being compressed to the aca vessel wall by the neuroform atlas stent.Post-procedurally, the patient initially woke up with a left-sided hemiparesis (m3); head ct was negative for acute intracranial findings, and the patient's clinical exam gradually recovered to baseline on post-procedure day 1 after being placed on moderate dose of vasopressors.Post-procedural ct showed mild narrowing of the right aca in the region of the stents, with no evidence of large vessel occlusion or high-grade stenosis otherwise.Few punctate acute-appearing infarctions were noted within the right frontal lobe in the right aca territory on the diffusion weighted imaging (dwi) post-operative magnetic resonance imaging (mri).The patient was continued on aspirin 325/day and ticagrelor 90mg twice daily, and was eventually discharged to rehab in stable baseline condition and ultimately home.

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The device remains implanted in the patient and could not be returned for analysis.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies migration or misplacement as potential complications associated with use of the device.Microvention inc.Manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2032493-2022- 00028 and 2032493-2022-00152 are related to this same incident.Article bibliography: salem, mohamed m., et al."bailout strategies for abrupt changing of the woven endobridge-17 (web-17) device orientation after detachments: technical note of 2 anterior communicating artery aneurysm cases." world neurosurgery (2022).

• Brand Name: WEB SL
• 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: 14113216
• MDR Text Key: 298803713
• Report Number: 2032493-2022-00151
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110843
• UDI-Public: (01)00842429110843(11)210419(17)240331(10)21041913J
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-5-2-MVI-3
• Device Catalogue Number: W5-5-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MICROVENTION 5F SOFIA INTERMEDIATE CATHETER; MICROVENTION SOFIA ASPIRATION CATHETER; MICROVENTION VIA 17 MICROCATHETER; MICROVENTION WEB SL17; PENUMBRA 6 FR BMX CATHETER; PENUMBRA BENCHMARK CATHETER; STRYKER NEUROFORM ATLAS STENTS
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male