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Model Number PED-450-30
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2017
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex delivery system was returned stuck within the distal segment of the microcatheter. The pipeline flex delivery system was then pushed out from the catheter lumen with difficulty. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The distal end of the pipeline flex braid was found fully opened with moderately frayed; while the proximal end of the braid was found fully opened with no damage. The pushwire was found to be bent near the proximal end. No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper. No other anomalies were observed. Based on the analysis findings, the event descriptions, the report of failure to open at the distal end issue, could not be confirmed as the distal end the returned pipeline flex braid were found fully opened with moderately frayed. The proximal end of the braid was found fully opened with no damage. It's possible that the "severe vessel tortuosity" and "damaged braid" may have contributed to the "failure to open" issue. However, the cause for damage could not be determined. Per our instructions for use (ifu), the user should: ¿place the micro catheter tip at least 20 mm past the distal edge of the aneurysm. Gently retract the micro catheter to reduce slack in the micro catheter prior to inserting pipeline flex embolization device. 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. Re-sheathing 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. 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. ¿ all products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
The device is expected to be returned for analysis, but has yet not been received. Therefore, as the device was not returned, we are unable to perform further root cause analysis.
Event Description
Medtronic received information that during deployment of the flow diverter device, the distal section did not open properly and got stuck in the micorcatheter. The device was unable to be removed from the catheter. The whole assembly was removed from the patient. The vessels anatomy was noted as being severely tortuous. No patient injury was reported. The device was not placed on a bend. Less than 50% of the device was deployed when it failed to open. The device was resheated less than or equal to 2 times. The devices were all used as directed in the ifu. The unruptured aneurysm is in the supraclinoid, it is saccular. The max diameter is 10mm with a neck of 4. 5mm. The landing zone was 3. 2mm distally and 3. 7mm.
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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 Key7206341
MDR Text Key271353084
Report Number2029214-2018-00045
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberPED-450-30
Device Catalogue NumberPED-450-30
Device Lot NumberA352570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial