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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX 4.00MM X 18MM INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX 4.00MM X 18MM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-18
Device Problem Difficult To Position (1467)
Patient Problems Infarction, Cerebral (1771); Paresis (1998)
Event Date 10/24/2016
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. We are unable to definitively determine the cause for the reported experienced. Furthermore, the cause for the post procedure complication is unknown. Mdrs related to this report: 2029214-2016-01054 2029214-2016-01055.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the cavernous segment of the ica, the pipeline (ped-350-16) moved back distally into the supraclinoid segment and was not opposed to the vessel wall. It was reported that the pipeline appeared to have been sized incorrectly. Therefore a second pipeline device (model and lot number unknown) was deployed to help hold the first device in place however, it also appeared to be too small. The snare retrieval device was used and the pipelines were telescoped. The anterior carotidal branch was covered by the pipeline. The flow in aneurysm was reduced and flow to distal vessels was good. After the procedure was complete the patient lost consciousness and an ischemic stroke was identified at the treatment site. In addition, the patient experienced left side weakness. The patient was later seen for a headache and continued left side weakness. It was later determined that the calibration of the system was off and had given incorrect measurements. The aneurysm max diameter was 6 mm and the neck diameter was 4mm. The distal landing zone was 3. 1 mm and the proximal was 3. 6 mm. The patient had moderate vessel tortuosity.
 
Manufacturer Narrative
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 received additional information that a ct scan was performed and the device was shown to be open. It was reported that the patient's headache has since resolved. Furthermore, the patient was reported to have only a slight right sided arm weakness deficit, and is otherwise completely intact.
 
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Brand NamePIPELINE FLEX 4.00MM X 18MM
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6126342
MDR Text Key106787184
Report Number2029214-2016-01055
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,Followup,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-400-18
Device Lot NumberA181201
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 Received10/31/2016
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

Patient Treatment Data
Date Received: 11/23/2016 Patient Sequence Number: 1
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