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

Model Number	PED-375-30
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex (ped) embolization device and marksman catheter were returned.The ped embolization device was returned within the marksman catheter.The pipeline flex embolization device and marksman catheter were decontaminated.The pipeline flex pushwire was found protruding from within the marksman hub.No damages were found with the marksman hub.The marksman catheter body was found accordioned and separated at the distal tip.The catheter was retained together by the inner wire.The distal section of the marksman catheter was found flattened including the distal marker/tip.The ped braid with delivery system was pulled out from within the marksman distal tip with resistance.The distal hypotube with the ptfe shrink tubing were found intact.The pushwire was found detached at the distal hypotube weld (solder joint).The distal segment of the ped pushwire (resheathing pad/marker, braid, ptfe sleeves, distal marker, and tip coil) were found detached.The marksman catheter distal segment was dissected (cut) and the distal segment of the ped pushwire was removed from within the catheter lumen.The proximal bumper, re-sheathing pad, re-sheathing marker, distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No damages were found with the tip coil.The pipeline flex braid ends were found fully open and in good condition.The detached pushwire was sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) elemental analysis.Based on the device analysis and reported information, the report of ¿lockup/resistance at distal segment¿ was confirmed.From the damages seen with the pipeline flex pusher and marksman catheter; it appears there was high force used.It is likely these damages occurred when attempted to advance the pipeline flex through the marksman catheter against resistance.It is likely the patient¿s ¿moderate¿ vessel tortuosity contributed to the event.However, the cause for the resistance could not be determined.Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to 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 or Problem Description
Medtronic received a report that the pipeline became stuck in the marksman microcatheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the ophthalmic artery with a max diameter of 10mm, 6.7mm neck diameter, and 3.0mm distal, 3.5mm proximal landing zone.It was noted the patient's vessel tortuosity was moderate.It was reported that the pipeline couldn't be pushed or opened normally in the marksman catheter as it became stuck in the middle of the catheter.The catheter was flushed continuously with heparinized saline, and no damaged was indicated to the catheter or pushwire.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.

• 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: 9778044
• Report Number: 2029214-2020-00187
• Device Sequence Number: 687938
• Product Code: OUT
• UDI-Device Identifier: 00847536015722
• UDI-Public: 00847536015722
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: 07/09/2022
• Device Model Number: PED-375-30
• Device Lot Number: A861606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR