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

Model Number PED2-450-30

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex embolization device and marksman catheter were returned for analysis.The pipeline flex embolization device was returned within the marksman catheter.The pipeline flex pusher was protruding from within the marksman catheter hub for ~43.4cm.The marksman catheter body was found accordioned at ~39.0cm, 21.8cm, and 19.0cm from the distal tip.In addition, the marksman catheter body was found accordioned from ~27.0cm to ~24.0cm from the distal tip.No damage was found with the marksman distal marker/tip.The marksman total length was measured to be ~165.7cm and the useable length was measured to be ~158.2cm which is within specification (specification: 160cm ± 3cm).The pipeline flex embolization device was pushed out from within the marksman catheter, deploying the braid, with resistance.The distal hypotube with ptfe shrink tubing was found intact.The pipeline flex pusher was found detached at the distal hypotube weld (solder joint).The resheathing pad and marker were found in good condition.The pipeline flex braid was found deployed on the pushwire.The pipeline flex braid proximal end was found open and in good condition.The pipeline flex braid distal end was found open, but damaged (frayed).The distal core wire was found to be broken with the ptfe sleeves and tip coil missing.The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows the presence of tin (sn).The pipeline flex distal pushwire was sent out for sem (scanning electron micrographic) analysis.Per the sem report, the wire end exhibits significant corrosion damage.No original fracture features are visible.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿resistance¿ and ¿catheter damage¿ were confirmed.From the damages seen with the pipeline flex (pusher separation, braid damage) and the marksman catheter (accordioning) it appears excessive force was used.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.However, the cause for the resistance could not be determined.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 information that pipeline flex with shield device stuck in the marksman catheter and catheter damaged.It was reported that positioned of microcatheter in the left middle cerebral artery (mca), programmed with pipeline and initiated its release.After 30% of the open pipeline, it was recaptured into the microcatheter for repositioning, as the pipeline was below the location that the doctor wanted.After the repositioning of the device started again, the pipeline is released, but the same does not occur in the microcatheter.Withdrawn of pipeline with the microcatheter and consider whether the microcatheter was damaged (stretched) in its distal part, making implantation of the device impossible.Replaced another microcatheter and pipeline and procedure completed without any issue.There were not any patient symptoms or complications associated with this event.No medical or surgical intervention needed to prevent a permanent impairment of a function.The angiographic result post procedure was ok.No images available for review.The pipeline and any accessory devices were prepared as indicated in the ifu.There was no reported harm or injury to the patient.There was no increase in the patient's hospitalization, but an increase of 30 minutes in the surgical time.The patient was undergoing embolization treatment with flow diverter.Additional information received reporting that the procedure was for embolization of a saccular cerebral aneurysm.The aneurysm measurement was 3x3mm with a neck diameter of 3mm.The catheter was continuously flushed during the procedure.There was some resistance felt between the pipeline and marksman catheter during delivery.When attempting to reposition the pipeline, it became stuck within the marksman catheter.

• 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: 11773881
• MDR Text Key: 249267529
• Report Number: 2029214-2021-00537
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2022
• Device Model Number: PED2-450-30
• Device Catalogue Number: PED2-450-30
• Device Lot Number: A806183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• 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