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

Model Number	PED-300-20
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the pipeline embolization device (lot no.A725992) found no flash or voids molded within the catheter hub.No damages or anomalies were found with the hub.The phenom-27 micro catheter body was found kinked at ~12.3 cm from the distal end.No damages or irregularities were found with the distal tip or marker band.The pipeline flex pusher and braid was found stuck within the phenom-27 catheter.The pipeline flex device could not be retracted or advanced out and the catheter was cut to remove the device.No damages were found with the pipeline flex proximal pusher.The hypotube was intact and unstretched and ptfe shrink tubing was found pulled back.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps ptfe sleeves were found intact with no signs of damage.The tip coil was found unstretched and undamaged.Once cut out of the micro catheter, the proximal braid was found severely damaged.The middle braid was found damaged, and the distal braid was found slightly damaged.Some of the damages found had occurred during the removal of the braid from the micro catheter when it was cut.The phenom-27 micro catheter total length was measured to be ~158.8 cm and the usable length was measured to be ~152.2 cm, which is within specification (specification: total (ref) = 156.5 cm, usable = 150 cm ± 5 cm).The inner diameter was measured to be 0.027¿ at both ends, which is within specification and compatible for use with the pipeline flex.Resistance testing could not be performed on the phenom-27 micro catheter as it was destroyed to extract the pipeline flex device.Based on the analysis findings, the pipeline flex and phenom-27 were confirmed to have ¿resistance/stuck during delivery¿ and ¿catheter resistance¿ as resistance was found with the returned pipeline flex within the catheter.Possible causes for resistance are damaged catheter, damage to the braid, patient vessel tortuosity, user does not maintain continuous flush, or user pulls back on/torques wire while advancing ped in micro catheter.Customer reported vessel tortuosity as normal, and devices were prepared per ifu.The pipeline flex and the phenom catheter were found damaged.From the damages seen on the catheter body (kink), ptfe shrink tubing (pulled back) and braid (damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the phenom catheter against the reported resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.There is no indication that the event is related to a potential manufacturing issue.Event reported in lieu of device analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a pipeline device that had resistance with a phenom 27 microcatheter.The patient was undergoing a procedure for flow diverter implant treatment of a posterior cerebral artery fusiform aneurysm.Vessel tortuosity was normal.Two pipelines were needed for the procedure.All devices were prepared and the catheter flushed according to the instructions for use (ifu).The first pipeline was deployed without issue.The second pipeline became stuck in the microcatheter during delivery.The phenom microcatheter and pipeline were withdrawn together and both devices replaced to complete the procedure successfully.There was no patient injury.Additional information received reported that there was resistance in the distal end of the microcatheter.There was no damage to the pipeline pushwire, catheter, and microcatheter.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12363409
• Report Number: 2029214-2021-01061
• Device Sequence Number: 11710837
• Product Code: OUT
• UDI-Device Identifier: 00847536014855
• UDI-Public: 00847536014855
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: PED-300-20
• Device Catalogue Number: PED-300-20
• Device Lot Number: A725992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR