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

Model Number FA-77375-14

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

Patient Problems Encephalopathy (1833); Neurological Deficit/Dysfunction (1982)

Event Date 12/18/2014

Event Type  Injury  

Event Description

Treatment of a small aneurysm measuring approximately 7mm located in the para-ophthalmic segment of the ica (internal carotid artery).The patient was given plavix and aspirin.The patient's baseline status was stable prior to the procedure.On (b)(6) 2014, the patient underwent pipeline embolization treatment.Mri (magnetic resonance imaging) post procedure suggested vasculopathy or posterior reversible encephalopathy syndrome.Mostly ipsilateral cerebral hemisphere.The relation to the adverse event may be that there was poor wall apposition proximally.The patient exhibited weak strength in the left arm and hand in relation to the reported adverse event.Medication was provided for the ae (specific name were not reported).The patient's current medical condition is good, 4 out of 5 returned strength.This institution does not test pru levels.No further complications were reported as a result of the procedure.

Manufacturer Narrative

The lot history record reivew was not possible since the lot number was not reported.The device involved in the event will not be returned for evaluation as it was implanted in the patient.(b)(4).

Manufacturer Narrative

Attempts to obtain the lot number of the ped were made, however the site was not be able to provide the lot number of the device.(b)(4).

Event Description

Subsequent to the initial mdr, medtronic (covidien) received new information regarding the patient's medical history.The patient had a rupture of right posterior communicating aneurysm 6 months prior to the pipeline embolization device (ped) placement.Follow up angiography showed that the aneurysm regrow with wide neck and it failed balloon assisted re-coilling.Post ped placement procedure, the patient developed severe headache that was refractory to steroids within a few hours.Three days post procedure, the patient presented to the emergency room with left hemiparesis and the magnetic resonance imaging (mri) showed presumed patchy edema in the right cerebral hemisphere.One month post procedure, the patient showed clinical improvement although not fully intact yet.

• Brand Name: PIPELINE EMBOLIZATIN 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; 9775 toledo way CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9492975480
• MDR Report Key: 4426707
• MDR Text Key: 21326357
• Report Number: 2029214-2015-00057
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-77375-14
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• 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: 50 YR