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); Intracranial Hemorrhage (1891)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2020-01338 for a related report from this article.If information is provided in the future, a supplemental report will be issued.

Event Description

Dmytriw aa, kapadia a, enriquez-marulanda a, et al.Vertebral artery aneurysms and the risk of cord infarction following spinal artery coverage during flow diversion.Journal of neurosurgery.March 2020:1-10.Doi:10.3171/2020.1.Jns193293 medtronic literature review found a report of patient complications in association with pipeline embolization devices (peds).The purpose of this article was to assess the association between coverage of the anterior spinal artery (asa), posterior spinal artery (psa), or lateral spinal artery (lsa) ostia when placing flow diverters in distal vertebral arteries (vas) and clinical outcomes, with emphasis on cord infarction.A review of 60 patients with 63 va and posterior inferior cerebellar artery aneurysms treated with flow diverters were reviewed.Fifty-eight of the 60 procedures used peds.Thirty-nine (65.0%) patients were female with a median age of 57.7 years.The article does not state any technical issues during use of the ped.The following intra- or post-procedural outcomes were noted: death occurred in 5 cases (8.6%), due either to initial sah or to intracranial hemorrhagic complication after the flow diverter placement.Of these, 3 deaths (5.0%) were a direct consequence of the device placement.Nine (15.0%) patients developed cerebral thromboembolic complications and 4 of them (7.4%) were symptomatic.From the overall sample of patients, cerebellar infarcts occurred in 6 cases (10.0%), pca territory infarct in 3 cases (5.0%), and brainstem infarct in 2 cases (3.3%).From the 9 patients who had thromboembolic complications, 2 had infarcts in two or more territories (one patient had brainstem, cerebellum, and pca infarctions, and the other patient had brainstem and cerebellum infarctions).Symptomatic thromboembolic complications occurred in 2 (22.2%) of 9 cases with acutely ruptured aneurysms versus 2 (4.0%) of 50 nonacutely ruptured cases.Six (10.0%) patients developed hemorrhagic complications, all of which were symptomatic.From the overall sample of patients, the types of hemorrhagic complications were subarachnoid hemorrhage (sah) in 3 (5.0%) cases, intraparenchymal hemorrhage (iph) in 2 (3.3%) cases, and iph and subdural hemorrhage (sdh) in 1 (1.7%) case.Symptomatic hemorrhagic complications occurred in 3 (30.0%) cases with acutely ruptured aneurysms versus 3 (6.0%) nonacutely ruptured cases.Two cases (3.5%) were re-treated.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11033936
• MDR Text Key: 224395447
• Report Number: 2029214-2020-01339
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 11/18/2020
• 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: 57 YR