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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 Foreign Body Reaction (1868); Neurological Deficit/Dysfunction (1982)
Event Date 04/01/2017
Event Type  Injury  
Manufacturer Narrative
Stack, c. , cole, j. , cronin, c. , shah, j. , kittner, s. , <(>&<)> gandhi, d. (2017). An unusual complication of pipeline stenting [abstract]. Neurology, april 18, 2017 vol. 88 no. 16 supplement p3. 296 the pipeline remains implanted in the patient; product analysis cannot be performed. Based on the information provided, there is no evidence suggesting that the event was due to a defect of the device. The cause of the patient's delayed foreign body reaction cannot be conclusively determined from the information provided.
 
Event Description
Medtronic literature review found a report of "embolization of stenting material" after pipeline implantation. The patient had undergone pipeline implantation in the treatment of an aneurysm in the left, cavernous internal carotid artery (ica). The procedure was uneventful. Two months after implantation, the patient presented acutely with changes in speech production during an exercise class. The exam was notable for paraphasic errors, inability to name objects, and inability to follow multistep commands as well as right lower quadrantanopsia and mild right nasolabial fold flattening. The patient was evaluated for acute stroke. Brain ct reveal hypodensities in the left cerebral hemisphere suggestive of vasogenic ed ema most notably in the left frontal and parietal lobes. Ct angiogram of the head and neck revealed a patent pipeline. Mri of the brain with and without contrast reveal multiple small foci of solid and peripheral enhancement with surrounding vasogenic edema. The patient was diagnosed as having a delayed foreign body reaction with granuloma formation due to embolization from the pipeline. The patient was treated with prednisone with improvement in the initially observed neurologic deficits, but only minimal improvement in the inflammatory response radiographically.
 
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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 Key6695453
MDR Text Key79354568
Report Number2029214-2017-00856
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 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
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 Received06/12/2017
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: 07/07/2017 Patient Sequence Number: 1
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