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); Paralysis (1997); Thrombosis/Thrombus (4440)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Cagnazzo f, ahmed r, lefevre ph, derraz i, dargazanli c, gascou g, riquelme c, frandon j, bonafe a, costalat v. Flow modification on the internal carotid artery bifurcation region and a1 segment after m1-internal carotid artery flow diverter deployment. Journal of neurointervent surgery. 2020;12:1226¿1230. Doi:10. 1136/neurintsurg-2020-016051. Age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. If information is provided in the future, a supplemental report will be issued.

Event Description

Cagnazzo f, ahmed r, lefevre ph, derraz i, dargazanli c, gascou g, riquelme c, frandon j, bonafe a, costalat v. Flow modification on the internal carotid artery bifurcation region and a1 segment after m1-internal carotid artery flow diverter deployment. Journal of neurointervent surgery. 2020;12:1226¿1230. Doi:10. 1136/neurintsurg-2020-016051. Clinical and hemodynamic consequences of flow diverters extending from the m1 to the internal carotid artery (ica), covering the a1 segment, have rarely been investigated. The purpose of this article was to provide angiographic and clinical data about flow modifications on the covered a1. The authors reviewed 42 cases of a1 arteries covered with a single device. Of the 42 patients, the average age was 54 years, 35 were female and 7 were male. Flow diverters were successfully deployed from the m1 to the ica segment in all patients. The mean diameter of the covered a1 was 2. 1 mm (median 2. 2 mm, sd 0. 4, range 1. 2¿3. 5 mm). Immediately after flow diversion deployment, 20 (47. 6%) covered a1 showed slow flow because of the flow compensation from the contralateral side through a patent acoma. No cases of immediate occlusion were recorded. The overall rate of complications related to the m1-ica flow diversion was 4. 7%, with 2. 3% morbidity. The article does not state any technical issues during use of the pipeline. The following intra- or post-procedural outcomes were noted: after prasugrel discontinuation at 6 months, one patient developed a basal ganglia infarct related to the coverage of the m1 perforators; the patient partially recovered with an mrs score of 1 at the 12 month follow-up. One patient had an acute instant thrombosis which completely resolved after treatment with abciximab, without any neurological sequelae.

• 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: 13560138
• MDR Text Key: 290453120
• Report Number: 2029214-2022-00237
• 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,Literature,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 01/28/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/18/2022 Patient Sequence Number: 1