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 Hemorrhage/Bleeding (1888); Rupture (2208); Obstruction/Occlusion (2422); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 09/25/2021

Event Type  Injury  

Event Description

Hosoo, h., ishikawa, e., tsuruta, w., sato, m., ito, y., hayakawa, m., takigawa, t., marushima, a., suzuki, k., hyodo, a., & amp; matsumaru, y.(2022).Antiplatelet therapy and periprocedural risk factor analysis for pipeline embolization device treatment of unruptured internal carotid artery aneurysms: a retrospective, multicenter analysis.World neurosurgery, 157.Https://doi.Org/10.10 16/j.Wneu.2021.09.109 summary: aneurysm treatment using the pipeline embolization device has been established but appropriate maintenance of dual antiplatelet therapy (apt) is essential.This multicenter retrospective study assessed whether apt was properly adjusted for clopidogrel resistance and identified risk factors associated with periprocedural complications.Identified events: 12 patients had re-treatment procedures and 1 patient had an emergent case.1 patient had stent thrombosis just after the procedure.6 patients had symptomatic distal embolisms in the cerebral hemispheres during the procedure.2 patients had occlusions of the retinal artery branches during the procedure.1 patient had a delayed occlusion of the anterior choroidal artery covered by ped 7 days after treatment.9 patients had periprocedural hemorrhagic complications, all of which occurred within 14 days after treatment, including 2 delayed aneurysmal ruptures, 1 delayed symptomatic remote intracerebral hemorrhage, 3 delayed asymptomatic remote intracerebral hemmorhages, and 3 delayed asymptomatic subarachnoid hemorrhages.1 patient had a delayed aneurysmal rupture in the carotid-cavernous fistula, which was remediated by subsequent transvenous embolization.4 patient's suffered morbidity due to periprocedural complications.Event notes: the mean aneurysmal maximum and neck sizes were 15.35 7.15 mm and 6.80 2.96 mm, respectively.Most of the treated aneurysms were located at paraclinoid or cavernous portions (90.12%).Adjunctive coiling was performed in 50 aneurysms (30.86%).

Manufacturer Narrative

Hosoo, h., ishikawa, e., tsuruta, w., sato, m., ito, y., hayakawa, m., takigawa, t., marushima, a., suzuki, k., hyodo, a., & amp; matsumaru, y.(2022).Antiplatelet therapy and periprocedural risk factor analysis for pipeline embolization device treatment of unruptured internal carotid artery aneurysms: a retrospective, multicenter analysis.World neurosurgery, 157.Https://doi.Org/10.10 16/j.Wneu.2021.09.109.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.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Associated regulatory report #: 2029214-2022-00272.

• 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: 13582297
• MDR Text Key: 292564292
• Report Number: 2029214-2022-00274
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/22/2022

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: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/22/2022
• 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): Disability; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female