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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-10
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2020
Event Type  malfunction  
Manufacturer Narrative
The phenom-027 (pli-10) (model: fg15150-0615-1s lot: au19-058), and pipeline flex catheter (pli-20) (model: ped-350-10 lot: a662943) were returned for analysis. The pipeline flex pusher was returned broken, with the distal segment stuck within the phenom-027 micro catheter, and the proximal segment returned separately. The braid was implanted into the patient, and not returned for analysis. Proximal core wire was found broken from hypotube with the ptfe jacket broken at the same area. The distal segment of the core wire was found still within the hypotube. The broken end was sent out for sem/eds testing. The micro catheter was flushed, and water did not exit the distal end. No flash, or voids molded were observed in the phenom-027 hub. Dried blood and contrast were found within the hub. The catheter total length was measured to be ~158. 6cm ,the usable length was measured to be ~151. 8cm, and the distal single coil length was measured to be ~14. 5cm, which is within specification. Phenom-027 micro catheter found kinked at ~5. 1cm from the distal end. The marker bands and distal tip were found intact. The pipeline flex pusher could not be retracted out of the micro catheter. The phenom-027 was cut in order to remove the pusher. When compared to the drawing, the distal and proximal dps restraints were found to be intact. The hypotube appeared to be intact and with no stretching, and the ptfe shrink tubing was found still intact. The ptfe dps sleeves were found intact with no signs of damage. No damages were found with the tip coil, distal marker, re-sheathing marker ,or with the proximal bumper. A 0. 0260¿ mandrel was used for resistance testing ,and became stuck at the kink when inserted into the distal tip. The proximal micro catheter was destroyed during the removal of the pipeline flex pusher, and could not be tested for resistance. No other anomalies were observed. The customer¿s report of ¿catheter resistance¿, and ¿resistance during retrieval¿ were confirmed as the devices were returned with the pusher stuck within the middle of the phenom-027. In addition, resistance was encountered within the catheter with in-house mandrel at the kinked location. Possible causes for catheter damage are patient vessel tortuosity, flush rate too low or lack of continuous flush, guidewire or delivery system damage, material occludes catheter, or insufficient guidewire or delivery system hydration. Customer reported vessel tortuosity as normal, devices were prepared, and used per instruction per use. It is likely the cause of the damage found to the pusher, and micro catheter occurred during the attempts to retract the pusher against the reported resistance. The sem results confirmed the damage: ¿the center wire exhibits dimple features that indicative of tensile overload type failure. Weld defects (porosity, lack of fusion) are visible at the weld area. ¿ per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered. 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 intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determ ined, 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline pushwire that got stuck in a phenom27 microcatheter during retrieval. The patient was being treated for an unruptured saccular cerebral aneurysm of the left internal carotid artery. Vessel tortuosity was normal. It was reported that the devices were prepared, and the catheter flushed as indicated in the instructions for use (ifu). The pipeline was delivered through the phenom27 microcatheter, and successfully deployed. The delivery wire was then, pulled back into the microcatheter, but could not be pulled out. The delivery wire was retained within the microcatheter, and the devices were removed from the patient's body together. On a table in the surgical area, surgical staff worked with the devices, and were able to advance the delivery wire forward out of the microcatheter with ease but again, became stuck pulling back for retrieval, and remained stuck in the microcatheter. There was no harm or injury to the patient. Additional information received reported the resistance was in the middle of the catheter, and no damage to the pushwire or catheter was observed.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10545087
MDR Text Key207297825
Report Number2029214-2020-00938
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/18/2021
Device Model NumberPED-350-10
Device Catalogue NumberPED-350-10
Device Lot NumberA662943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2018
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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