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

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

Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Vasoconstriction (2126)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

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 event causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2019-00743.If information is provided in the future, a supplemental report will be issued.

Event Description

Bender, m.T., zarrin, d.A., campos, j.K., lin, l., huang, j., caplan, j.M.,.Coon, a.L.(2019).Tiny pipes: 67 cases of flow diversion for aneurysms in distal vessels measuring less than 2.0 mm.World neurosurgery, 127.Doi: 10.1016/j.Wneu.2019.02.204.Medtronic literature review found reports of patient complications during or after pipeline placement.The purpose of this article was to review the results of pipeline treatment in the treatment of sub-2.0mm vessel aneurysms.The authors reviewed the results of 57 patients who underwent ped treatment.Of the 57 patients, 40 were female and the average age was 55.8 years.The article notes the following intraprocedural or post-procedural complications: 26 cases required vasospasm treatment with intra-arterial verapamil.5 cases had intraprocedural platelet aggregation along the device - 5 cases had concomitant intraprocedural administrations of abciximab 2 cases had small-volume dependent intracerebral hemorrhage that resolved without permanent neurological deficit the article notes that patients experienced post-procedure stroke resulting in permanent neurological deficit.Acute stent occlusion was observed intraprocedurally or within 24 hours in all 3 cases: one stroke occurred during treatment of an unruptured 9 mm mca aneurysm treated with pipeline and adjunctive coiling.The minimum mca diameter was 1.2 mm in this case.After the stroke, the patient had an mrs of 4.One stroke occurred in a patient with a previously ruptured and coiled recurrent a2-a3 aneurysm with a minimum parent vessel diameter of 1.3 mm.After the stroke, the patient had an mrs of 4.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8791334
• MDR Text Key: 151104113
• Report Number: 2029214-2019-00742
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 06/17/2019
• 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; Required Intervention