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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
Model Number PED-500-16
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Brand name
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pipeline flex with shield the device has been returned and evaluation is anticipated. A supplemental report will be submitted upon completion of investigation.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the left parophthalmic, the device was not opening distally. It was reported that the device was pushed to the distal end of microcatheter and the whole system was pulled backwards to cover the aneurysm neck and to take the slack away. The microcatheter was thereafter pulled to open the distal end of the device. The microcatheter was pulled approximately half of the length of the device and "no opening" of the device was seen. The device was resheathed and redeployed three times with no success. Thereafter the device was pulled back into the microcatheter and removed from the patient. The aneurysm was treated with coiling and a competitors stent.
 
Manufacturer Narrative
Device available for evaluation - additional information type of follow up - device evaluation. Device evaluated by manufacturer. Additional information: the device was returned within a competitors microcatheter. For further examination, the device was removed from the catheter hub. The device was found fully opened with damaged braid at both ends. The customer¿s clinical observation could not be confirmed. Based on the analysis we are unable to conclusively determine the cause of this event. The damage to the braid on both ends of the pipeline is likely the result of the physician resheathing the device more than the recommended two times. Per our instructions for use, the user should "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously. The system is designed to allow for 2 full cycles of resheathing of the pipeline flex embolization device. Resheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. ¿ suspect medical device
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pipeline flex with shield technology model #
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ped2-500-16. 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.
 
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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 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 Key5525122
MDR Text Key108299452
Report Number2029214-2016-00163
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFI
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,Followup
Report Date 04/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/12/2018
Device Model NumberPED-500-16
Device Lot NumberA058016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2015
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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