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

Model Number FA-77375-18

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

Patient Problems Facial Nerve Paralysis (1846); Failure of Implant (1924)

Event Date 02/28/2015

Event Type  Injury  

Event Description

Information received from the article: kerolus m, kasliwal mk, lopex dk.Persistent aneurysm growth following pipeline embolization device assisted coiling of a fusiform vertebral artery aneurysm: a word of caution!.Neurointervention.2015 feb;10(1):28-33.Medtronic (covidien) received information from literature review as follows: a patient with a history of uncontrolled hypertension was admitted to our neuroscience intensive care unit from an outside institution with a diagnosis of a hunt + hess grade 4/fisher grade 3 sah (subarachnoid hemorrhage).An evd (external ventricular drain) was placed on admission and a digital subtraction angiography (dsa) was performed which demonstrated presence of the right vertebral artery fusiform aneurysm with the posterior inferior cerebellar artery (pica) arising from the base of a focal dilatation from the fusiform aneurysm segment.After consideration of all the treatment options, endovascular treatment was elected in view of poor grade sah and patient's cardiopulmonary status.He underwent coil embolization along with placement of a pipeline across the aneurysm.A 6-french guide catheter was used to selectively catheterize the right vertebral artery.A microcatheter was subsequently placed into the vertebral artery with coiling of the focal dilatation arising off the aneurysm along with deployment of a 3.75mm ¿18 mm pipeline completely covering the fusiform vertebral aneurysm for vessel remodeling.A raymond class ii occlusion of the focal dilatation arising from the fusiform aneurysm was achieved.The patient was loaded with aspirin and clopidogrel during the procedure.The evd was converted to a ventriculo-peritoneal shunt before the patient was discharged home in good neurological condition.The patient was alert and oriented with no focal deficits at discharge except presence of right sided sixth cranial nerve palsy.Dual antiplatelet agents were prescribed for 6 months following the procedure.Routine follow up angiography done at 6 months as per our institutional protocol showed coil compaction and enlargement and regrowth of both the focal dilatation and the fusiform aneurysm without migration of the pipeline stent.Even though the patient was asymptomatic, considering significant enlargement of the aneurysm with a prior presentation with sah, the patient was taken back to the neuro-interventional suite with placement of three overlapping pipelines (3.5 mmx18x2 and 3.5x14 mm) to increase the overall coverage area and further reduce the shear stress which possibly caused the aneurysm to continue growing despite treatment with a single pipeline on presentation.The post procedure course was uneventful and the patient was discharged home with no new neurological deficits.A follow up angiography was performed at 3 months which showed no residual aneurysm with no neurological deficits on clinical examination.

Manufacturer Narrative

Http://dx.Doi.Org/10.5469/neuroint.2015.10.1.28.The report was created to capture the post procedure complication.The information was received from the article: kerolus m, kasliwal mk, lopex dk.Persistent aneurysm growth following pipeline embolization device assisted coiling of a fusiform vertebral artery aneurysm: a word of caution!.Neurointervention.2015 feb;10(1):28-33.The device will not be returned as it was implanted in the patient.The lot history record review was not possible as the lot numbers were not reported.(b)(4).

• 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: 4700579
• MDR Text Key: 5726013
• Report Number: 2029214-2015-00390
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-77375-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 04/16/2015
• 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; Disability
• Patient Age: 43 YR