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 Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Stenosis (2263); Therapeutic Response, Decreased (2271)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

Mcdougall, c.M., khan, k., saqqur, m., jack, a., rempel, j., derksen, c., chow, m.(2017).Ultrasound for the evaluation of stenosis after flow diversion.Journal of neurointerventional surgery.Doi:10.1136/neurintsurg-2017-013049 the pipeline devices will not be returned for evaluation as it remains implanted in the patients.Based on the information provided in the article, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and its causes could not be conclusively determined from the provided information.

Event Description

Medtronic literature found reports of moderate to severe in-stent stenosis, intracranial hemorrhage (ich), and aneurysm recurrence after pipeline implantation.The purpose of this article was to evaluate the use of transcranial doppler ultrasound (tcd) for in-stent stenosis after flow diversion.The authors compared patients¿ follow-up angiographic and tcd results for correlation.The authors retrospectively reviewed 28 patients who underwent flow diversion with the pipeline embolization device (ped).Twenty-five patients (21 women, 4 men, average age 45 years) were available for follow-up; of those patients, angiographic and tcd information were available for 23.The authors observed the following outcomes: - patient 11 underwent ped placement for an incidentally found 5mm internal carotid artery (ica) aneurysm.Sometime post-procedure, the patient experienced intracranial hemorrhage (ich) and persistent hand weakness.- patient 12 underwent ped placement for an incidentally found 5mm ophthalmic aneurysm.Follow-up angiography showed moderate in-stent stenosis, which remained as of 6-months post-procedure.- patient 14 (middle aged) presented with subarachnoid hemorrhage (sah) with early hydrocephalus.Angiography demonstrated a 2mm blister aneurysm on the right supraclinoid ica.The patient underwent ped placement post-hemorrhage day 4 and was discharged home post-hemorrhage day 11.Three-month follow-up angiography showed 50% narrowing within the ped.Six-month follow-up angiography showed improvement with minimal residual stenosis.The patient was asymptomatic.- patient 19 presented with a previously-coiled, 16mm, recurrent pcoa aneurysm and underwent placement of two peds.Sometime post-procedure, the patient experienced aneurysm recurrence requiring placement of a second ped.- patient 21 presented with cn iii palsy and underwent placement of two peds to treat 25mm, cavernous ica aneurysm.Follow-up angiography showed severe, in-stent stenosis.The article classified stenosis as mild (0-50%), moderate (50-70%), and severe (>75%).

• 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: 6757565
• MDR Text Key: 81561275
• Report Number: 2029214-2017-00929
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2017

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: 07/25/2017
• 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