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Model Number PED-400-25
Device Problems Difficult to Open or Close (2921); Activation Failure (3270)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 07/04/2018
Event Type  malfunction  
Manufacturer Narrative
This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
pipeline flex w/shield technology model #
ped2-400-25. The device has been received and device evaluation anticipated, but not yet begun. Upon completion of the device evaluation a supplemental report will be filed. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received information that this pipeline flex with shield technology embolization device that did not open at the distal segment. The patient underwent embolization treatment for a medium unruptured saccular aneurysm located in right cavernous segment. Measuring 12mmx11mmx8mm, landing zone distal 3. 8mm proximal 4. 0mm. It was reported that the physician had placed the microcatheter and started to open the pipeline, but after he opened around 1cm he realized that the most distal part didn't open. The physician resheathed the pipeline and tried once more and again it didn't open. During this manipulations microcatheter has lost the position and the physician tried to reach to the distal part but couldn't achieve. After that removed everything from the patient and finished the case. No patient injury was reported.
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
The clinical observation could not be confirmed. As received, distal and proximal ends of the pipeline flex shield braid appeared fully opened with moderately frayed. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact without any damages. The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation. No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper and pushwire. Based the analysis findings, we were unable to determine the cause of failure to open in the distal section during the procedure. The returned pipeline flex braid was found fully opened. It is possible it is possible that the patient's vessel tortuosity" may have contributed to the reported issue. The damage to the braid on the ends of the pipeline flex shield is likely the results of the customer re-sheathing the device more than recommended two times. All products are 100% inspected for damage and irregularities during manufacture. Per our instructions for use (ifu), the user should "begin to deliver the device using a combination of unsheathing the pipeline flex with shield embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex with shield has successfully expanded, deploy the remainder of the device. The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex with shield embolization device. Re-sheathing the pipeline flex with shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. Carefully inspect the deployed pipeline flex shield embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked. If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it. 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. ¿ if information is provided in the future, a supplemental report will be issued.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
MDR Report Key7739003
MDR Text Key116057340
Report Number2029214-2018-00690
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
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 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2021
Device Model NumberPED-400-25
Device Lot NumberA613447
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial