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Model Number PED-425-20
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation; therefore, the event cause could not be determined. Correspondence has been received stating that the device has been sent back. Once the device has been received and evaluated, a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received information that the flow diverter device failed to open in the middle and distal segment during an off-label procedure to treat an aneurysm modified in fistula. The aneurysm measured 5mm by 4mm and was located in the in the cavernous segment of the left internal carotid artery (ica). The distal and proximal landing zone was 4. 5mm x 4mm. The middle segment of the flow diverter was not positioned on a bend. The flow diverter had been deployed approximately more than 50% when this occurred. The flow diverter was resheathed less than or equal to two times. The flow diverter could not be totally resheathed as it was blocked by the sleeves. The flow diverter was resheathed and removed with the microcatheter from the patient. Post procedural imaging showed no slowing down of blood flow. No patient injury was reported as a result of the event. The patient¿s vasculature was reported to be severe in tortuosity. It was also noted that the flow diverter was did not exit protective sheath smoothly and a continuous flush was maintained during the procedure. Yes, there was resistance felt when the flow diverter was being navigated through the microcathet er.
Manufacturer Narrative
The pipeline flex delivery system and the catheter used in the event were returned for evaluation and the tip coil and the sleeves appeared to be stuck outside of the catheter tip. The remaining segment of the pushwire was found within the catheter lumen. For further examination, the pipeline flex delivery system was then pushed out from the catheter lumen with difficulty. The pipeline was examined and the distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The pipeline braid was found fully opened with no damage. The pushwire was found to be bent near the proximal end. No other defects were found with the pipeline. The phenom 27 microcatheter was examined and the body was found to be accordion near the distal tip. The catheter was flushed with water and found to be patent. The catheter was then tested by running an in-house mandrel through catheter tip and hub and it was able to pass through the catheter tip and hub; however, resistance was observed at the accordion location. No other anomalies were observed. Based on the analysis findings and the event descriptions, the customer reports of ¿resistance during delivery¿, ¿failure to resheath¿ and ¿catheter resistance¿ were confirmed as the tip coil and sleeves of the returned pipeline flex were found to be stuck outside of the catheter tip. In regards to ¿failure to open at the distal end and middle section¿ issues, the customer complaint could not be confirmed as the returned pipeline flex braid was found fully opened with no damage. The returned pipeline flex and the phenom catheter were found to be damaged. The customer reported that the devices were prepared per the ifu and a continuous flush with heparinized saline was maintained during procedure. In addition, the patient¿s vessel tortuosity was severe. It is possible that the ¿severe vessel tortuosity¿ may have contributed to the reported resistance. From the damages seen on the catheter body (accordioning), proximal wire (kinking/bending) and hypotube (stretching); it appears there was high force used (pushing and pulling). It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex delivery system through the phenom catheter against resistance. Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device. Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device. Carefully inspect the deployed pipeline flex embolization device with shield technology 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. Discontinue delivery of the device if high force or excessive friction is encountered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. 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. ¿ no evidence was found to suggest that the devices failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause. All products are 100% inspected for damage and irregularities during manufacture. 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
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key7474495
MDR Text Key106964620
Report Number2029214-2018-00353
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 06/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2019
Device Model NumberPED-425-20
Device Lot NumberA280225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial