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

Model Number PIPELINE

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

Patient Problem Numbness (2415)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Article website: http://jnis.Bmj.Com/content/early/2014/07/03/neurintsurg-2014-011281.Full.Off label use: treatment of posterior circulation aneurysms (giant basilar sidewall aneurysm).The pipeline¿ embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments.The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.Mdrs from the same article mdr# 2029214-2015-00922 (case 1), mdr# 2029214-2015-00924 (case 6), mdr# 2029214-2015-00925 (case 7).

Event Description

Medtronic (covidien) received information from literature review that one patient experienced mass effect that required steroid treatment post pipeline embolization device (ped) procedure.The patient was diagnosed with a giant basilar sidewall aneurysm with mass effect and significant compression of the pons and midbrain structures.Angiographic images showed delayed, limited filling of the basilar apex and distal posterior circulation vessels, and small bilateral posterior communicating arteries.The aica were difficult to identify, but were suspected to originate at the base of the giant aneurysm.Flow diversion treatment was performed with two pipeline stents in an overlapping fashion.Immediate stagnation was noted in the aneurysm.Post-procedural head ct showed progressive thrombosis of the aneurysm with minimal filling of the aneurysm sac at 5 days.Steroid treatment was maintained for 3 weeks after the procedure for presumed mass effect.The patient was discharged home on day 7.A follow-up angiogram at 7 months showed complete aneurysm occlusion with patency of the aica.Mri at 12 months showed no significant residual aneurysm filling and marked regression of the large aneurysm sac.The patient had only mild, improved residual facial and body sensory deficit (numbness) at 1 year.Intermittent diplopia (pre-existing symptom) had resolved.The patient had mrs of 1.In this article, the authors presented their posterior circulation flow diverter experience, outcomes, and morbidity in comparison with recent studies.A retrospective chart and imaging review of six patients with seven aneurysms in posterior circulation vessels, treated with flow diverter technology was carried out.It was concluded that flow diversion may be a possible treatment in carefully selected patients with high-risk atypical posterior circulation aneurysms, with poor natural history and no optimal treatment strategy.Symptomatic and fusiform large aneurysms appear to carry the highest risk.Further studies are necessary to assess the role of flow diversion in the posterior circulation.Citation: toth g, bain m, hussain ms, et al.Posterior circulation flow diversion: a single-center experience and literature review.J neurointerv surg.2015 aug;7(8):574-83.Doi: 10.1136/neurintsurg-2014-011281.

• 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 ; 9498373700
• MDR Report Key: 5029837
• MDR Text Key: 24044927
• Report Number: 2029214-2015-00923
• 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
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PIPELINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 30 YR