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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Hemorrhage, Cerebral (1889); Neurological Deficit/Dysfunction (1982)
Event Date 03/19/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post procedure and its cause was unknown.
 
Event Description
Medtronic received information that this patient developed eye movement disorder five days post pipeline treatment and recovered. Two weeks later the patient developed systematic cerebral infarction at the pipeline treatment area and the next day developed a systematic cerebral hemorrhage at the pipeline treatment site. One month post procedure that patient was evaluated with mrs 5. The patient was treated for an aneurysm located in the paraclinoid segment of the left internal carotid artery. The aneurysm was un ruptured and saccular and previously coiled. The max diameter was 20 mm the neck width is unavailable.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6499135
MDR Text Key107030613
Report Number2029214-2017-00456
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received03/22/2017
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

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