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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-71300-25
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device was not returned for analysis; therefore the event cause could not be determined. Per pipeline instruction for use: "after the entire ped is deployed, advance the microcatheter through the ped making sure not to dislodge the ped. ".
 
Event Description
Medtronic received information that the distal end of the pipeline accidentally dislodged into the aneurysm. The patient was treated for an unruptured, fusiform, wide-necked (14 mm) aneurysm located in the left vertebral artery aneurysm arising proximal of the pica. It was reported that the pipeline was initially deployed nicely across the aneurysm. Upon removal of the pushwire and advancement of the microcatheter to capture distal protective coil, the device was accidentally dislodged into the aneurysm. The physician decided to telescope another pipeline into the first device to cover the distal segment. The patient is doing fine as timely preventative action taken by physician. Post angiographic results showed slow flow within aneurysm with good stasis. No patient injury was reported as a result of this procedure.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
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 Key5570618
MDR Text Key106358476
Report Number2029214-2016-00217
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 03/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/15/2018
Device Model NumberFA-71300-25
Device Lot NumberA174426
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 Received03/16/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2015
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: 04/12/2016 Patient Sequence Number: 1
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