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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 Occlusion (1984); Stenosis (2263); Therapeutic Response, Decreased (2271); Thromboembolism (2654)
Event Type  Injury  
Manufacturer Narrative
Moshayedi h, omofoye oa, yap e, oyekunle to, sasaki-adams dm, solander sy, factors affecting the obliteration rate of intracranial aneurysms treated with a single pipeline embolization device, world neurosurgery (2017), doi: 10. 1016/j. Wneu. 2017. 04. 111. The pipeline devices will not be returned for evaluation as they remain implanted in the patients. Product analysis will not be performed. The events do not appear to be related to any defect of the pipeline devices. The information provided in the article is not enough to conclusively determine the cause of the patients' procedural and post-procedural complications.
 
Event Description
Medtronic literature review found reports of embolic stroke, artery occlusion, and retreatment after pipeline implantation. The purpose of this study was the analyze the outcomes of intracranial aneurysm treatment using a single pipeline embolization device (ped). The authors wanted to specifically evaluate the factors affecting aneurysm obliteration rates. The authors retrospectively reviewed 47 patients who underwent treatment for 58 aneurysms. All patients were treated using a single ped. Forty two of the patients were female and the mean age was 52. 8 years. The article states that two patients experienced small embolic strokes during the procedure; the strokes were confirmed on mri. - the article states that one patient continued to have headaches and diplopia after the procedure, but was otherwise neurologically intact. The article states the patient¿s symptoms were likely unrelated to the embolic stroke. - the second patient developed left sided weakness, facial droop, and pronator drift after the procedure. Mri demonstrated a few tiny foci of restricted diffusion, but symptoms resolved completely a few days later at discharge. The article states that one patient experienced occlusion of the ophthalmic artery after ped implantation. The ped had been implanted to treat a cerebral aneurysm; the ophthalmic artery arose from the aneurysm neck. Follow-up angiography showed the aneurysm was completely obliterated; the angiogram also showed the ophthalmic artery (which arose from the aneurysm neck) was also occluded. The patient did not experience any visual symptoms despite ophthalmic artery occlusion. The article states that one patient underwent retreatment after ped implantation. The patient underwent ped implantation in the treatment of an aneurysm; the ophthalmic artery arose from the aneurysm neck. The patient¿s one-year post-procedure angiogram showed incomplete aneurysmal obliteration. After two years of incomplete aneurysm occlusion, a second ped was placed. The aneurysm remained patent on angiographic follow-up.
 
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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 Key6613227
MDR Text Key76710304
Report Number2029214-2017-00732
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2017
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 Received05/09/2017
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: 06/05/2017 Patient Sequence Number: 1
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