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

Model Number PED2-450-16

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis of the pipeline embolization device (lot no.B119717) found that no flash or voids molded were within the marksman micro catheter hub.No damages or anomalies were found with the hub.The marksman micro catheter body was found accordioned between ~27.7 cm and ~23.7 cm; and between ~8.7 cm and ~4.7 cm from the distal end.No damages or irregularities were found with the distal tip or marker band.The pipeline flex w/ shield distal delivery wire and distal braid were found extending out of the distal tip of micro catheter.The exposed distal braid was found damaged.The pipeline flex w/ shield was found stuck within the marksman micro catheter and could not be advanced/retracted out.The marksman was cut to extract the pipeline flex w/ shield pusher and braid.Dried blood was found within the catheter and on the pusher/braid.No damages were found with the pipeline flex proximal pusher.The hypotube was found stretched with the ptfe shrink tubing was found damaged.It is possible part of the stretching occurred during the extraction.No damages were found with the proximal bumper.The resheathing pad and resheathing marker were found loose on the distal delivery wire.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found intact.The proximal braid was occluded with blood and did not open.The blood was dissolved, and the braid fully opened.Slight fraying was found on the proximal braid.The marksman micro catheter total length was measured to be approximately 157.3 cm and the usable length was measured to be ~149.8 cm, which is within specification (specification: total (ref) = 157 cm ¿ 3 cm; usable = 150 cm ¿ 3 cm).The inner diameter was measured to be 0.0265 at the proximal end, which is within specification and compatible for use with the pipeline flex w/ shield.The distal inner diameter could not be measured as it was damaged during the extraction.Resistance testing with in-house mandrel could not be performed due to the catheter being destroyed.Based on the analysis findings, the pipeline flex w/ shield and marksman catheter were confirmed to have resistance during re-sheathing/failure to resheath and catheter resistance as resistance was found with the returned pipeline flex w/ shield within the marksman catheter.From the damages seen on the micro catheter (accordion), braid (damaged/frayed), resheathing pad/marker (separation from distal wire), hypotube (stretch) and ptfe shrink tubing (damage), it appears high force was used.It is likely these damages occurred when attempting to retract/advance the pipeline flex w/ shield against high resistance.Possible contributors are patient vessel tortuosity, insufficient continuous flush or the dried blood found within the device.There is no indication that the event is related to a potential manufacturing issue.The event was reported in lieu of analysis results.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline was unable to be resheathed with the marksman catheter.The patient was undergoing treatment for an aneurysm.¿dual antiplatelet treatment was not administered.It was reported that for both products the washing protocol and the implantation technique were followed correctly.When trying to recapture the pipeline into the marksman microcatheter to enable repositioning of the system, there was no trapping of the pipeline in the marksman making it impossible for the implant to continue.The pipeline and marksman were replaced, and the new device was successfully implanted.¿no extended hospitalization or additional medical or surgical interventions were needed as a result of the event.¿the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Additional information received indicated the patient was being treated for a bi-lobulated saccular aneurysm in the right posterior communicating (pcom) artery measuring 8 mm in diameter.There was no previous damage to the wire or catheter observed.

• 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: 12363261
• MDR Text Key: 268050575
• Report Number: 2029214-2021-01060
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: PED2-450-16
• Device Catalogue Number: PED2-450-16
• Device Lot Number: B119717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• 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