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 Hematoma (1884); Perforation (2001)

Event Date 02/01/2020

Event Type  Death  

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 presenting with right-sided weakness and right visual field cut was found to have a complete occlusion within the proximal left posterior cerebral artery (nihss ¼ 11).During microcatheterization, a collicular perforator arising from p1 was avulsed, and extravasation was noted.This was controlled with a balloon microcatheter, and resolution of the extravasation was noted.The thrombectomy was then aborted (tici ¼ 0).Postprocedural ct showed a large amount of extravasated contrast and blood in the basal cisterns, in particular within the interpeduncular fossa.In addition, hyperdensity in the midbrain raised suspicion for intraparenchymal hemorrhage, later excluded by mri.Sequential ct scan of the head demonstrated progressive absorption of contrast by the midbrain.The patient died 10 days later.

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.Date of event: 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.The 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: 13425525
• MDR Text Key: 284908088
• Report Number: 2029214-2022-00138
• 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

• 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
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/02/2022
• 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): Death