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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-14
Device Problem Activation Failure (3270)
Patient Problem Intimal Dissection (1333)
Event Date 03/07/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device will not be returned for analysis as it was implanted in the patient. We are unable to definitively determine the cause for the reported experience. However, this patient had severe vessel tortuosity. The pipeline flex ifu, states, "do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. " mdrs related to this report. 2029214-2017-00369 2029214-2017-00370.
 
Event Description
Medtronic received information that during treatment of an aneurysm two pipeline devices did not open distally as the patient had severe vessel tortuosity. It was noted that the middle section of the first pipeline (ped-500-16) was positioned on a bend and less than 50 % was deployed when it failed to open. The pipeline was resheathed more than 2 times and removed from the patient with the microcatheter. A new pipeline (ped-500-14) and microcatheter were used and the second pipeline also did not open distally. Balloon angioplasty was performed to ensure wall apposition and vessel dissection occurred during dilatation of a non-medtronic balloon catheter. It was further reported that the balloon was inflated 4-5 times. Post angiographic result showed extravasation of vessel.
 
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Brand NamePIPELINE FLEX
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 Key6459002
MDR Text Key106096309
Report Number2029214-2017-00370
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
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-14
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 Received03/07/2017
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: 04/04/2017 Patient Sequence Number: 1
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