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

Model Number PED2-375-14

Device Problems Unintended Ejection (1234); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex with shield (ped2) was returned within a dispenser coil.The introducer sheath was returned separated from the device.No damages or irregularities were found with the pushwire.The distal hypotube was found stretched.The ptfe shrink tubing was found still intact.No damages or anomalies were found with the proximal bumper, resheathing pad or resheathing marker.The delivery wire was found broken from the resheathing pad.The distal segment (ptfe dps sleeves, distal marker and tip coil) were not returned for analysis.The broken end was sent out for scanning electron microscopy (sem) analysis.The braid was already deployed and not returned for analysis.The returned device could not be used for resistance testing due to the damaged condition.No other damages or anomalies were found with the devices.Based on the analysis findings, the report of the ¿pipeline flex with shield could not be deployed¿ could not be confirmed.The sem analysis concluded that the wire failed via torsional overload.From the damages seen on the hypotube and distal wire; it appears there was high force used.It is likely these damages occurred when attempted to advance and or retract the pipeline flex with shield through the marksman catheter against resistance.Possible contributors for resistance are damaged catheter, incompatible catheter, frayed ends on braid, user pulls back on/torques wire while advancing ped2 in microcatheter, patient vessel tortuosity or lack of continuous flush during delivery.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 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.¿ report of braid deploying in the hub of the catheter during retraction could not be confirmed.Potential causes of failure include resistance during delivery, high force delivery, operator did not have the sheath properly seated in the hub of the microcatheter, pushwire was torqued/pulled back during insertion or advancing ped inside microcatheter, or user resheaths device more than 2 times.As the braid, ptfe dps sleeves, distal marker, tip coil and microcatheter were not returned for analysis, any contribution of the braid, ptfe dps sleeves, distal marker, tip coil and microcatheter towards resistance/stuck during delivery and device opening prematurely could not be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the pipeline flex with shield was not able to deploy.The pipeline flex with shield deployed in the hub of the microcatheter as it was pulled back during resheathing.A new pipeline flex with shield was used to complete the procedure with no further complications.No patient injury was reported as a result of the event.The devices were prepared and used per the instructions for use (ifu).A continuous flush was used.The catheter was discarded by the customer.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9908215
• MDR Text Key: 202732224
• Report Number: 2029214-2020-00313
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AE
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: PED2-375-14
• Device Lot Number: A757213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• 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