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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN, IRVINE PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-375-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Headache (1880); Seizures (2063)
Event Date 04/01/2016
Event Type  Injury  
Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient. There was no report of product defect or failure to meet specification. The cause of the event could not be conclusively determined.
 
Event Description
Medtronic received information that a patient complained of headache and seizure 2 years after a pipeline implant. A recent pathology report of the patient's brain tissue and meningeal biopsy stated "there was presence of non polarizable material, acute inflammation and giant cell reaction are suggestive of granulomatous inflammation secondary to embolization material or infectious etiology and sarcoidosis. " the pathology report also stated there was no evidence of vasculitis. The pipeline was implanted in the patient's right internal carotid artery. The physician did not report any product issue. The patient began to have symptoms of headaches and seizures about 1 1/2 years ago. Current diagnosis for the symptom manifestation is micro abscesses in the brain. The patient's physician reported prior to the pipeline implant, the patient had not had any neurological problems. The patient also had no medical history that was relevant to her current diagnosis. No known allergy was reported. The patient is being treated with anti-seizure medication and steroid. Under the treatment, patient's condition is without deficit.
 
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Brand NamePIPELINE FLEX
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 Key7007947
MDR Text Key91288547
Report Number2029214-2017-01237
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/24/2018
Device Model NumberPED-375-16
Device Lot NumberA079252
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 Received10/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/25/2015
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: 11/07/2017 Patient Sequence Number: 1
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