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); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2021-00805 for a related report from the article.If information is provided in the future, a supplemental report will be issued.

Event Description

Lauzier dc, root bk, kayan y, et al.Pipeline embolization of proximal middle cerebral artery aneurysms: a multicenter cohort study.Interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.May 2021:15910199211015578.Doi:10.1177/15910199211015578 medtronic literature review found a report of patient complications in association with a pipeline device.The purpose of this article was to measure safety and efficacy for pipeline embolization in the proximal middle cerebral artery in a multi-center cohort.Of the 24 patients reviewed, 15 were female (60%), and the average age was 53.7 years (range 16-72 years).The following intra- or post-procedural outcomes were noted: - one pipeline herniated into the aneurysm during the procedure.A second pipeline was deployed through the first device into aneurysm outflow tract.This did not result in clinical sequelae.- one patient experienced ischemic stroke secondary to pipeline thrombosis 4 months post-treatment.This patient was not treated with thrombolytic therapy and was discharged 2 days after presentation with a return to normal level of function (mrs 0).This patient¿s aneurysm was occluded at follow-up imaging.No additional complications occurred.The patient¿s aneurysm was located in the m1 segment.- one patient experienced ischemic stroke with thrombosis of pipeline two weekspost-procedure.Iv and ia abciximab administration restored patency of the ped, and the patient was discharged 5 days after initial stroke presentation with a return to baseline level of function (mrs 0).This patient¿s aneurysm was occluded at this time.No additional complications occurred.The patient¿s aneurysm was located in the m1 segment.- in-stent stenosis or occlusion was observed at 6-month and finial follow-up imaging for two patients.This comprised of one case of 10% stenosis and one case of complete pipeline occlusion.- two aneurysms were re-treated with a pipeline following initial pipeline treatment, with subsequent complete occlusion in one aneurysm and subsequent subtotal filling in the other.- three patients had clinically silent infarcts identified with cross-sectional imaging.The patients were asymptomatic.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12105213
• MDR Text Key: 261689245
• Report Number: 2029214-2021-00806
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• 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