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

Model Number PED2-475-18

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

Medtronic received information that a ped2 pipeline had resistance in the phenom27.The patient was being treated for an unruptured saccular aneurysm with a maximum diameter of 7 mm and a neck diameter of 2 mm.The distal landing zone was 4.8 mm and the proximal landing zone was 4.4 mm.The location was the right internal carotid artery.Dual antiplatelet therapy was preformed.Pru level was 100.Vessel tortuosity was moderate.The devices were prepared as indicated in the package insert.  phenom27 was induced to right m1.The product was inserted after ectogenesis preparation was performed.No resistance was felt during insertion into the introducer sheath.The sheath was removed as all the wires inserted into the introducer sheath; when the inside of the phenom 27 was inserted again, the resistance increased when insert it about 10cm.It was a strong resistance, while the tortuosity was not particularly strong, and although it somehow induced to the tip of phenom 27, there was no change in the strong resistance, so both ped and phenom 27 were removed.Both products were changed to a new one, the procedure was continued, and it was completed successfully.The catheter was flushed with heparin-added saline solution during the procedure.The pipeline was not stuck.No symptoms were reported.Medtronic received a report that the pipeline was inserted into the product after external preparation was performed.During insertion into the introducer sheath, there was no resistance felt and that was because all of the wires were still inserted into the introducer sheath, it was removed and when it was continuously inserted for about 10 cm, the resistance became stronger.Even when guiding it until the phenom 27 tip, the strong resistance did not change and both the pipeline and phenom 27 were removed.Both products were replaced and the procedure was completed successfully.It was indicated the catheter resistance was in the shaft center.The catheter was wet as per the package insert.The device was prepared as indicated in the package insert.The procedure was for pipeline positioning.The patient's blood vessel tortuosity was moderate.

Manufacturer Narrative

Pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex pusher was found extending from within the phenom 27 catheter hub for 46.0cm.No bends, kinks, or damages were found with the phenom 27 catheter body.The pipeline flex tip coil was found extending out from within the phenom 27 distal tip.No damages were found with the phenom 27 distal tip.The pipeline flex embolization device could not be removed from within the phenom 27 catheter as it was found stuck.The phenom 27 catheter was dissected (cut) and the pipeline flex embolization device was removed.No bends or kinks were found with the pipeline flex pusher.The pipeline flex pusher was found detached at the distal hypotube weld (solder joint).Both ends of the pipeline flex braid were found damaged (frayed).No damage was found with the pusher sleeves or tip coil.The phenom 27 catheter total length was measured to be 156.2cm and the useable length was measured to be 149.7cm which is within specification (specification: 150cm ± 5cm).The detached pusher was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pusher end shows the presence of tin (sn).Based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report was confirmed.The i investigation determined that these events were similar to events 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 ¿moderate¿ vessel tortuosity contributed to the event.Regarding the solder joint separation issue, this event is similar to events that had already been investigated, and another investigation is not necessary.Based on the formal investigation conducted, solder joint separation can occur due to excessive force or inadequate solder/tinning.As the analysis showed the 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 was performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to a specification that led to the detachment issue.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14197975
• MDR Text Key: 291404168
• Report Number: 2029214-2022-00708
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2022

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 Model Number: PED2-475-18
• Device Catalogue Number: PED2-475-18
• Device Lot Number: B271128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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: 78 YR
• Patient Sex: Female