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); Nausea (1970); Visual Disturbances (2140); Ptosis (2620)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Capocci r, shotar e, di maria f, et al.Delayed treatment (=5 days) by flow diversion of ruptured blister-like cerebral aneurysms: case series of 8 consecutive patients.Clinical neuroradiology.2020;30(2):287-296.Doi:10.1007/s00062-019-00758-4.Medtronic literature review found a report of patient complications in associated with pipeline embolization device flow diverter stent.The purpose of this article was to evaluate the safety and effectiveness of a delayed (=5 days) flow diversion strategy for the treatment of ruptured intracranial blister-like aneurysms (blas).The authors reviewed 9 cases of blas in 8 patients.The study consisted of 2 men and 6 women with a mean age of 52 ± 8.9 years and range of 39¿69 years.Six of the patients were implanted with a pipeline embolization device, and the other two patients were implanted with a stryker surpass stent.Most of the patients (5/8; 62.5%) had an mrs <(><<)>2 at discharge.The immediate periprocedural control angiogram showed a complete exclusion of the aneurysm in one patient (12.5%) but at follow-up (mean delay = 19.8 months) all patients had a complete aneurysm occlusion.All patients had a long-term mrs <(><<)>2.The article does not state any technical issues during use of the pipeline.The following intra- or post-procedural outcomes were noted: one patient had a major complication consisting of an acute ischemic stroke.No in-stent thrombus was observed on the immediate post-stent deployment dsa.As they emerged from general anesthesia, the patient complained of diplopia and nausea and had bilateral ptosis.An mri was immediately performed and revealed multiple infarcts in the cerebellum, thalami and medulla oblongata on diffusion weighted imaging (dwi) and mra showed an occlusion of the proximal right pca (p1 segment), which was supplied by a patent ipsilateral posterior communicating artery.The patient¿s condition gradually improved within a few weeks with a bilateral oculomotor and facial nerve palsy and a minor cerebellar syndrome at discharge.At last follow-up (65 months) only a minor cerebellar syndrome remained in this patient.

• 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: 10998589
• MDR Text Key: 221278529
• Report Number: 2029214-2020-01288
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• 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: 11/13/2020
• 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): Other
• Patient Age: 56 YR