MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Neurological Deficit/Dysfunction (1982); Stenosis (2263); Thromboembolism (2654)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

Atallah, e., saad, h., bekelis, k., chalouhi, n., tjoumakaris, s., hasan, d.,.Jabbour, p.(2017).The use of alternatives to clopidogrel in flow-diversion treatment with the pipeline embolization device.Journal of neurosurgery, 1-6.Doi:10.3171/2017.5.Jns162663.The pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the provided information, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2018-00318.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found reports of complications after pipeline implantation.The purpose of this article was to examine the safety and efficacy of prasugrel in the management of clopidogrel-resistant patients treated for cerebral aneurysms.The authors retrospectively reviewed 437 patients who underwent treatment with the pipeline embolization device (ped).The patients' mean age was 56.3 years; 62 were female and the rest were male.The patients were split into two antiplatelet groups: clopidogrel patients (374 patients) and prasugrel/ticagrelor patients (22 patients).Of the 374 patients who received clopidogrel: twenty-three patients had intra-ped stenosis, 28 patients experienced thromboembolic events, 21 patients experienced hemorrhagic complications of the 22 patients who received prasugrel or ticagrelor: two patients experienced intra-ped stenosis, 1 patients experienced arteriovenous v3 fistula, 1 patients experienced ophthalmoplegia and a ptosis of the left eye, 1 patient experienced thromboembolic event (word-finding difficulty) all prasugrel/ticagrelor patients had an (b)(6) of = 2 at their latest follow-up visit.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7449960
• MDR Text Key: 106139000
• Report Number: 2029214-2018-00317
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• 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: 04/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• 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