MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SOLITAIRE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hematoma (1884); Hemorrhage/Bleeding (1888); Ischemia (1942); Perforation (2001); Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 02/01/2020

Event Type  Injury  

Event Description

Raz, e., dehkharghani, s., shapiro, m., nossek, e., jain, r., zhang, c., ishida, k., tanweer, o., peschillo, s., <(>&<)> nelson, p.K.(2020).Possible empirical evidence of glymphatic system on computed tomography after endovascular perforations.World neurosurgery, 134.Https://doi.Org/10.1016/j.Wneu.2019.10.089.Summary: the glialelymphatic pathway, glymphatics, is a fluidclearance pathway first described in vivo in rodents consisting of a para-arterial route for the flow of cerebrospinal fluid (csf) along perivascular spaces and subsequently toward the brain interstitium.Primary evidence for glymphatics has included time-sequenced ex vivo fluorescence imaging after intrathecal infusion of csf tracers, with further human in vivo studies confirming similar mechanisms and documenting abnormal clearance in some pathologic conditions such as alzheimer disease or normal-pressure hydrocephalus.Identified events: 1.A patient presented with a right middle cerebral artery (mca) syndrome and a distal m1 occlusion.During thrombectomy, the clot f ragmented and migrated partially to the distal inferior division m2; after m2 inferior division thrombectomy with a solitaire stentriever.(thrombolysis in cerebral infarction [tici] score ¼ 3), a small area of active contrast extravasation was noted.This was con trolled with the inflation of balloon microcatheter across the leaking segment.Final angiography demonstrated resolution of contrast extravasation with unsubtracted images showing widespread subarachnoid iodinated contrast.The patient woke from anesthesia with r esolution of her weakness and new-onset headache and was followed with serial non-contrast ct of head, which demonstrated progressive absorption of contrast by the brain parenchyma and resolution of subarachnoid iodine; a follow-up magnetic resonance imaging (mri) scan (obtained at 72 hours from thrombectomy) showed very small ischemic infarct in the posterior right insula.The patient was discharged shortly thereafter with excellent outcome (discharge nihss ¼ 1).2.A patient presented with right-sided weakness and aphasia related to clot in the left inferior division mca (nihss ¼ 11).After t hromboaspiration, a smaller embolus was noted to have migrated distally in the m3 precentral branch of the left mca.Given the high eloquence of the territory supplied by this occluded branch, a more distal catheterization for thrombectomy was attempted.During m icrocatheterization, the precentral artery was perforated with resulting large subarachnoid and intraparenchymal hemorrhage, which was controlled eventually with intra-arterial injection of n-butyl cyanoacrylate with final result of tici ¼ 2a.Postprocedural ct showed a large amount of contrast and blood in the subarachnoid space as well as an intraparechymal hematoma; sequential ct of the head demonstrated progressive absorption of contrast by the brain parenchyma surrounding the intraparenchymal hematoma.The patient was discharged to long-term rehab care 1 month later with nihss ¼ 22.

Manufacturer Narrative

Raz, e., dehkharghani, s., shapiro, m., nossek, e., jain, r., zhang, c., ishida, k., tanweer, o., peschillo, s., <(>&<)> nelson, p.K.(2020).Possible empirical evidence of glymphatic system on computed tomography after endovascular perforations.World neurosurgery, 134.Https://doi.Org/10.1016/j.Wneu.2019.10.089 b.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Date validity is month/year valid.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13425559
• MDR Text Key: 285348441
• Report Number: 2029214-2022-00139
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SOLITAIRE
• Device Catalogue Number: UNK-NV-SOLITAIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• 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