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

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

Patient Problems Hemorrhage, Subarachnoid (1893); Visual Impairment (2138); Thromboembolism (2654)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient.Attempts were made to obtain additional information, however, our attempts were unsuccessful.The device performed as intended as indicated by successful deployment of the device in the intended located.Thromboembolism, vision deficient, and hemorrhage are known inherent risk of endovascular procedure and is documented in our device¿s instruction for use.The thrombus was treated with eptifibatide which resolved the event.The cause of the local thrombus formation cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the complaint, the most likely cause for the complaint is the patient condition.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

Citation: pipeline embolization device for small paraophthalmic artery aneurysms with an emphasis on the anatomical relationship of ophthalmic artery origin and aneurysm.Griessenauer cj1, ogilvy cs1, foreman pm2, chua mh3, harrigan mr2, stapleton cj4, patel ab4,he l5, fusco mr5, mocco j6, winkler pa7, patel as1, thomas aj1.J neurosurg.2016 dec;125(6):1352-1359.Epub 2016 mar 4.Medtronic received report of 3 symptomatic thromboembolic complication.One patient experienced thrombosis of the left a1 segment of the anterior cerebral artery during the procedure.This was treated with eptifibatide with successful recanalization of the occluded segment.However, postprocedural imaging revealed subarachnoid hemorrhage (sah).At the last follow-up, the patient had no focal neurological deficits.There was report of 2 permanent visual deficits; these patients underwent a formal neuro-ophthalmological evaluation and did not require intervention.

• Brand Name: PIPELINE
• 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 ; 9492753836
• MDR Report Key: 6447594
• MDR Text Key: 71323954
• Report Number: 2029214-2017-00288
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• 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: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention