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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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%).
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL 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 Key6757565
MDR Text Key81561275
Report Number2029214-2017-00929
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
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 Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/01/2017 Patient Sequence Number: 1
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