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

Model Number PED2-450-16

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 05/10/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a pipeline flex with shield that had resistance at the distal end of the catheter and became stuck and the pushwire was damaged.The patient was undergoing a procedure for flow diversion treatment of an unruptured saccular aneurysm of the right internal carotid artery (ica) c7 segment at the ica/posterior communicating artery bifurcation.Dual antiplatelet treatment (dapt) was administered.Vessel tortuosity was normal.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).The stent was inserted into the microcatheter and advanced but it became stuck in the distal part of the microcatheter.The physician attempted to release the slack in the system but this did not resolved the issue.The microcatheter was removed with the stent in the center of the guide catheter.An attempt was made to remove the pipeline from the microcatheter but the devices were entangled and damaged each other.The catheter was damaged and it was noted that the pipeline pushwire was also kinked at the middle segment.It was noted that the catheter was flushed continuously with heparinized saline.The devices were replaced to complete the procedure.There was no harm or injury to the patient.Post-procedure angiography results were ok.Ancillary devices: cook 90cm sheath, benchmark 071 115cm guide catheter, excelsior xt27 microcatheter.Additional information was received and it was reported that when physician tried to pull out from the microcatheter, pipeline sucked in the microcatheter and then it broke away from the guide.It refers to pipeline and to the catheter.

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex pusher was returned for analysis within a shipping box, within a sealed bio-pouch, and within a dispenser coil.A (styrker) excelsior xt-27 catheter (ref: xt275081 lot: 22081514) was returned within the shipping box and within a dispenser coil.Visual inspection/damage location details: the pipeline flex distal hypotube was found stretched with the shrink tubing intact.The pusher resheathing pad was found damaged.The pusher was found broken proximal to the sleeves.The excelsior xt-27 catheter was examined.The pipeline flex braid was found with the hub.There does not appear to be any damage to the catheter hub, body, or distal tip.The excelsior xt-27 catheter was flushed, blood and water exited from the tip.The excelsior xt-27 catheter was dissected (cut), and the pipeline flex braid was removed from within the hub.The braid ends were found open but damaged (frayed).An in-house 0.026¿ mandrel was inserted through the excelsior xt-27 catheter; however, the pipeline flex pusher sleeves and tip coil were not recovered.It is possible the sleeves and pusher were inadvertently flushed out of the catheter during analysis.Testing/ analysis: the excelsior xt-27 catheter total length was measured to be ~155.0cm and the useable length was measured to be ~148.8cm.The pipeline flex pusher distal core wire was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via torsional overload.Conclusion: based on the device analysis and reported information, the customer's "lockup/resistance at distal segment of catheter" report could not be confirmed.However, the customer's "pushwire kink/damage" and "pushwire break/separation" reports were confirmed.No apparent damages were found with the returned excelsior xt-27 catheter that would have contributed to the event.Advancing the device against resistance likely caused the damage found with the pipeline flex pusher resheathing pad and braid.In addition, from the damages seen with the pipeline flex pusher (stretching), it appears force was used.The investigation determined that this event was similar to those already investigated, and another investigation is not necessary.Based on the investigation conducted, resistance can occur during the device's tracking, deployment, and re-sheathing in distal and tortuous anatomies.The patient's vessel tortuosity was "normal." therefore, the cause for the resistance could not be determined.Regarding the broken pipeline flex pusher distal core wire, the investigation determined that this event was similar to an eve nt that had already been investigated, and another investigation is not necessary.Based on the formal investigation, pusher separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.As the core wire failed via torsional overload, it is likely some force was used.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13338773
• MDR Text Key: 293843498
• Report Number: 2029214-2022-00090
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2023
• Device Model Number: PED2-450-16
• Device Catalogue Number: PED2-450-16
• Device Lot Number: B087995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2021
• Date Manufacturer Received: 01/20/2022
• Date Device Manufactured: 09/17/2020
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 86 KG