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 Intracranial Hemorrhage (1891); Rupture (2208); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)

Event Date 03/01/2006

Event Type  Injury  

Manufacturer Narrative

Lylyk i, scrivano e, lundquist j, ferrario a, bleise c, perez n, lylyk pn, viso r, nella-castro r, lylyk p.Pipeline embolization devices for the treatment of intracranial aneurysms, single-center registry: long-term angiographic and clinical outcomes from 1000 aneurysms.Neurosurgery online.September 2021.Doi: cns.Org/spotlight.If information is provided in the future, a supplemental report will be issued.

Event Description

Lylyk i, scrivano e, lundquist j, ferrario a, bleise c, perez n, lylyk pn, viso r, nella-castro r, lylyk p.Pipeline embolization devices for the treatment of intracranial aneurysms, single-center registry: long-term angiographic and clinical outcomes from 1000 aneurysms.Neurosurgery online.September 2021.Doi: cns.Org/spotlight.Medtronic literature review found reported of incomplete wall apposition and wire perforation in association with pipeline embolization.The purpose of this article was to investigate long-term outcomes from the pipeline embolization devices for the treatment of intracranial aneurysms (pedestrian) registry.The authors reviewed 835 patients (march 2006 to july 2019) with complex ias treated with ped.Patients with unfavorable anatomy and/or recurrence following previous treatment were included and excluded those with acute subarachnoid hemorrhage.Of the 835 patients, the average age was 55.9 years, 671 were female and 164 were male.In total, 1214 peds were deployed, with a single device in 84.2% (842/1000) and =2 devices in 95.8% (958/1000) of cases.Adjunctive coiling was performed in 9.3% (93/1000).Intraoperative technical complications occurred in 4.8% (48/1000) of treated aneurysms, with incomplete wall apposition of the device requiring balloon angioplasty representing the majority of technical complications (3.3% [33/1000]).Stroke-related complications occurred in 3.6% (30/835) of patients, the majority of which were caused by in-stent thrombosis (2.5% [21/835]).Nine deaths occurred due to stroke.They found a trend towards lower rates of thromboembolic complications since the implementation of prasugrel, with 26 (4.4%) patients on clopidogrel developing stroke compared with 4 (1.6%) patients on prasugrel.Hemorrhagic complications occurred in 1.8% (15/835) of patients, resulting in 11 deaths.The overall morbidity rate, including from subarachnoid hemorrhage, was 2.7% (23/835).The all-cause mortality rate was 4.6% (38/835), with a neurological mortality rate of 3.1% (26/835).The following intra- or post-procedural outcomes were noted: incomplete wall apposition requiring balloon angioplasty.Wire perforation.Distal thrombosis/embolism 4 stroke, in stent thrombosis.Hemorrhage, aneurysm rupture.Intraparenchymal hemorrhage.Neurological mortality.Mortality.

• 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: 13217876
• MDR Text Key: 286156440
• Report Number: 2029214-2022-00030
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/11/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female