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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-250-14
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2015
Event Type  malfunction  
Manufacturer Narrative
The device was not returned as it remains in the patient; therefore we are unable to determine the cause of this event. In addition, the lot number for this device was not provided.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the left pericallosal artery the device was deployed distal to the aneurysm into the a1 artery; upon retrieving the pusher wire, the device was "pushed back" into the a1 artery. A microcatheter was then navigated through the first pipeline and was placed past the aneurysm into the a2 and a second device was deployed from distal to the aneurysm into the a1 artery covering the aneurysm neck. There were no clinical complications. No further information was provided.
 
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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 Key5351370
MDR Text Key35287976
Report Number2029214-2016-00010
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeEI
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
Report Date 10/16/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-250-14
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 Received10/16/2015
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

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