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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-375-12
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Infarction, Cerebral (1771); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982); Vasoconstriction (2126); Therapeutic Response, Decreased (2271)
Event Date 08/18/2014
Event Type  Injury  
Manufacturer Narrative
Heit, j. J. , telischak, n. A. , do, h. M. , dodd, r. L. , steinberg, g. K. , <(>&<)> marks, m. P. (2017). Pipeline embolization device retraction and foreshortening after internal carotid artery blister aneurysm treatment. Interventional neuroradiology. Doi:10. 1177/1591019917722514. The pipeline flex device remains implanted in the patient; product analysis cannot be performed. It should be noted that the ped was placed in the treatment of a ruptured, blister aneurysm, for which the device is not indicated for use. The article states that the patient likely had an underlying connective tissue disorder resulting in changes in ica vessel caliber; the increased vessel caliber led to retraction (foreshortening) of the ped. Based on the provided information, foreshortening does not appear to have been due to any defect of the device. In addition, the article states that the patient experienced vasospasm resulting in cerebral infarction and neurological deficits. The cause of the vasospasm could not be conclusively determined from the provided information. Mdrs related to this article: 2029214-2017-01078. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found a report of pipeline retraction and foreshortening after placement. A middle-aged patient presented with severe headache due to subarachnoid hemorrhage (hunt and hess scale score 2, glasgow come scale 15, fisher grade score 3). Digital subtraction angiography (dsa) identified a left internal carotid artery (ica) blister aneurysm and bilateral cervical ica dissections. The decision was made to proceed with endovascular treatment using flow diversion devices. On dsa, the left ica diameter proximal to the aneurysm was 3. 6 mm. Two telescoping pipeline embolization devices (ped) were placed across the aneurysm. The first ped (3. 75 x 12 mm) was placed 2 mm distal to the edge of the blister aneurysm and 1 mm proximal to the origin of the anterior choroidal artery. A second ped (3. 75 x 10 mm) was placed 5 mm distal to the distal edge of the first ped (just proximal to the ica terminus) and the proximal aspect of the second ped terminated with the first ped proximal to the blister aneurysm. Dual antiplatelet therapy (aspirin 81 mg, clopidogrel 75 mg daily) was initiated at the time of treatment with a 24-hour intravenous eptifibatide bridge. The patient reportedly did well immediately after treatment, but became unresponsive five days after treatment. Head ct showed new subarachnoid hemorrhage. Antiplatelet medications were ceased and platelets were administered. A second dsa showed increased diameter of the supraclinoid ica (which measured 5. 2 mm proximal to the aneurysm) and increased aneurysm size. The two peds had retracted by 6 mm and there was increased growth of the aneurysm. The patient underwent successful balloon test occlusion followed by endovascular parent vessel occlusion for aneurysm treatment. The patient was then transferred to the operating room where an uncomplicated direct left external carotid artery to middle cerebral artery bypass surgery was performed to provide additional blood flow to the left anterior circulation in the event that the patient developed vasospasm. Two days after vessel sacrifice, the patient developed severe vasospasm despite aggressive endovascular treatment with intraarterial nicardipine and cerebral angioplasty of the contralateral right supraclinoid ica, a2, m1. The vasospasm resulted in cerebral infarction. The patient was left with neurologic deficits that included receptive and expressive aphasia as well as right hemiplegia.
 
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Brand NamePIPELINE FLEX 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 Key6899280
MDR Text Key87586060
Report Number2029214-2017-01077
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
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 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-375-12
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 Received08/31/2017
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: 09/27/2017 Patient Sequence Number: 1
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