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

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.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL 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 Key: 10545087
• MDR Text Key: 207297825
• Report Number: 2029214-2020-00938
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015241
• UDI-Public: 00847536015241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: PED-350-10
• Device Catalogue Number: PED-350-10
• Device Lot Number: A662943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1