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

Model Number PED2-425-25

Device Problems Positioning Failure (1158); Physical Resistance/Sticking (4012)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The event is reported at this time based on analysis results.Product analysis findings: the pipeline flex embolization device was returned for analysis within the non-medtronic catheter.The pipeline flex pusher was found extending out from within the catheter hub for ~50.7cm.The distal end of the catheter body was found flattened.The pipeline flex pusher tip coil was extending out from within the catheter tip.The pipeline flex pusher was removed from within the catheter without issue.No bends or kinks were found with the pipeline flex pusher.However, the pusher was found detached at the distal hypotube weld (solder joint).There was no evidence of stretching or elongation with the pipeline flex pusher.The catheter was dissected (cut) and the pipeline flex distal segment was removed.The proximal bumper and resheathing pad detached from the pusher during removal.The resheathing pad was found within the braid proximal end.The braid proximal end was found in good condition.The braid distal end was found damaged (frayed).The ptfe sleeves were found in good condition.The tip coil outer coils were found stretched.The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectr oscopy) elemental analysis.The elemental analysis of the detached pushwire end shows the presence of tin (sn).Based on the device analysis and reported information, the customer¿s report of ¿resistance¿ was confirmed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.It is likely the patient¿s ¿severe¿ vessel tortuosity contributed to the event.In addition, it is possible that the damage found with the catheter (flattening) contributed to the resistance.Regarding the solder joint separation issue and distal wire separation issue these events are similar to events that had already been investigated, and another investigation is not necessary.Based on the formal investigation conducted, pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.Solder joint separation can occur due to excessive force or inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that lead to the resistance and detachment issues.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that after the xt 27 was delivered to the distal m1, the pipeline was advanced into the microcatheter.The pipeline was stiff and pulled the microcatheter to fall down to the aneurysm, but the pipeline was not deployed yet.The doctor then took the entire system out, and replacement products were used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery (ica) siphon segment with a max diameter of 24.4 mm and a 8.9 mm neck diameter.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was not tested.Additional information received reported that there was a little resistance when the pipeline was advanced to the aneurysm.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12222538
• MDR Text Key: 263441891
• Report Number: 2029214-2021-00917
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: P100018.S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2021

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: 05/09/2023
• Device Model Number: PED2-425-25
• Device Catalogue Number: PED2-425-25
• Device Lot Number: B022589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 07/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2020
• 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 Weight: 55