MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number FA-55150-1030

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2021-01371 for the pipeline involved in this event.The pipeline flex device and marksman micro catheter were returned for analysis.No damages or irregularities were found with the marksman catheter hub.Dried blood was found within the hub.The pipeline flex pusher was extending out the hub ~390cm.The marksman micro catheter body found accordioned at ~8.3cm, ~9.2cm, ~10.0cm, ~116.0cm, and between ~126.0 and ~132.0cm from the proximal end.The micro catheter outer tubing was found separated at ~28.7cm from the distal tip with the two segments retained by the inner wire.The marksman micro catheter tip and marker band was found intact and undamaged.The pipeline flex dps sleeves and tip coil were found extending out of the micro catheter distal tip.No damages or irregularities were found with the dps sleeves, the distal and proximal dps restraints or tip coil.The pipeline flex hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damages were found with the distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.The distal braid end was found fully opened, severely damaged and frayed.The proximal braid end was found fully opened, damaged and frayed.The marksman micro catheter total length and usable length could not be measured due to the damages.The pipeline flex device was found stuck within the marksman micro catheter and had to be cut out.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.The braid was confirmed damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braids were returned already deployed and out of its protective introducer sheath and dispenser coil.Customer reported all devices were prepared per ifu, vessel tortuosity was severe, distal end of the pipeline was placed in a bend, device was resheathed less than or equal to two times.The severe tortuosity and device placed in a bend likely contributed towards the failure to open.The marksman micro catheter was found accordioned and broken.Possible causes are patient vessel tortuosity, user advance/retrieve device against resistance, device removed aggressively, or catheter entrapment.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline was always in a flattened state in the anterior curve segment of the c4 after multiple operations, and the push-pull operation could not be opened all the time.The pipeline failed to open in the middle and distal sections.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 20mm and a 17mm neck diam eter.It was noted the patient's vessel tortuosity was severe.It was reported that the pipeline was always in a flattened state in the anterior curve segment of the c4 after multiple operations, and the push-pull operation could not be opened all the time.The pipeline failed to open in the middle and distal sections.The distal end of the pipeline was positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to two times.There were no additional steps or other devices required to open the pipeline.The pipeline was replaced with a new pipeline and the operation was successful.There were no patient symptoms or complications associated with this event.It was unknown if a dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed a giant aneurysm in the cavernous sinus segment.The pipeline was not used for an indication that was not approved and the devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13295264
• MDR Text Key: 293933275
• Report Number: 2029214-2022-00070
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536026261
• UDI-Public: 00847536026261
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2024
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 222237646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/19/2022
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female