MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problems Hemorrhage/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

Adeeb n, griessenauer cj, foreman pm, moore jm, motiei-langroudi r, chua mh, gupta r, patel as, harrigan mr, alturki ay, ogilvy cs, thomas aj, comparison of stent-assisted coil embolization and pipeline embolization device for endovascular treatment of ophthalmicsegment aneurysms: a multicenter cohort study, world neurosurgery (2017), doi: 10.1016/j.Wneu.2017.05.104.The pipeline devices will not be returned for evaluation as they remain implanted in the patients; product analysis cannot be performed.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 its cause could not be conclusively determined from the information provided in the article.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found a report of patient complications after pipeline implantation.The purpose of this article was to present a comparative study of endovascular treatment options for ophthalmic segment aneurysms of the internal carotid artery (ica).The authors compared stent-assisted coil embolization and flow diversion (pipeline embolization device).In this pipeline group, 91 patients underwent treatment for 106 aneurysms.Of the pipeline patients, 92.5% were female and the median age was 57 years.The article states that the following outcomes were observed in the pipeline group: - 1 patient underwent endovascular retreatment after pipeline implantation - 5 patients experienced a post-treatment mrs of 3-6; baseline mrs of these patients was not provided.- 8 patients experienced worsened mrs on follow-up.- 10 patients experienced neurological complications - 8 patients experienced thromboembolic complications - 2 patients experienced hemorrhagic complications - 1 patient experienced permanent visual deficit.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6757380
• MDR Text Key: 81509627
• Report Number: 2029214-2017-00927
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• 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: 07/07/2017
• 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