MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

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

Patient Problems Stroke/CVA (1770); Granuloma (1876); Intracranial Hemorrhage (1891); Obstruction/Occlusion (2422)

Event Date 08/19/2021

Event Type  Injury  

Event Description

Liang, f., ma, c., zhu, h., liu, l., liang, s., jiang, p., zhang, y., amp; jiang, c.(2021).Using angiographic parametric im aging-derived radiomics features to predict complications and embolization outcomes of intracranial aneurysms treated by pipeline embolization devices.Journal of neurointerventional surgery.Https://doi.Org/10.1136/neurintsurg-2021-017832 summary: pipeline embolization devices (peds) have gained widespread popularity in the treatment of intracranial aneurysms (ias).However, precise predictors of treatment outcomes are still lacking.This study aimed to use angiographic parametric imaging (api)-derived radiomics features to explore whether biomarkers extracted from immediate postprocedural digital subtraction angiography (dsa) were associated with complications and embolization outcomes of ias treated with ped without adjunctive coils.Identified events: 4 patients had mass effects as a periprocedural complication.5 patients had subarachnoid hemorrhage as a periprocedural complication.3 patients had intraparenchymal hemorrhage as a periprocedural complication.7 patients had minor ischemic stroke as a periprocedural complication.6 patients had major ischemic stroke as a periprocedural complication.7 patients had parent artery occlusion as a delayed complication.1 patient had minor ischemic stroke as a delayed complication.1 patient had major ischemic stroke as a delayed complication.1 patient had a mrs score of 3-5.10: 5 patients had a mrs score of 6.Event information: the mean maximum diameter of the aneurysms was 10.46±7.35mm.The rate of on-label use of the ped was 69.4%, including 9.25% for cavernous carotid ias, 55.16% for paraophthalmic ias, and 4.98%14 for posterior communicating artery ias.The rates of off-label use of the ped were as follows: m1 and m2 segments of the middle cerebral artery ias, 1.78% and 0.71%, respectively; vertebrobasilar ias, 27.76%; and p2 segment ias, 0.36%.The majority of the patients had one ped; nine patients had two peds and one patient had four peds.Saccular aneurysms 155 (55.16%) non-saccular aneurysms 126 (44.84%).

Manufacturer Narrative

Liang, f., ma, c., zhu, h., liu, l., liang, s., jiang, p., zhang, y., amp; jiang, c.(2021).Using angiographic parametric im aging-derived radiomics features to predict complications and embolization outcomes of intracranial aneurysms treated by pipeline embolization devices.Journal of neurointerventional surgery.Https://doi.Org/10.1136/neurintsurg-2021-017832.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 13519428
• MDR Text Key: 289197410
• Report Number: 2029214-2022-00216
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Female