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

Model Number PED-500-25

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

No damages or irregularities were found with the returned introducer sheath.The hypotube was found stretched.The distal delivery wire was found separated from the hypotube proximal to the wire weld.Under a microscope, the hypotube hole was examined and solder was found around the opening.The distal delivery wire was not returned for analysis.The pipeline flex device could not be used for resistance in catheter hub testing due to the damages.The hypotube was sent out for sem and eds testing.The marksman catheter total length was measured and found to be ~157.6cm and the usable length was found to be ~150.8cm which is within specification per drawing: total length (reference) = 157cm ± 3cm and usable length = 150cm ± 3cm.No damages or irregularities were found with the marksman catheter hub.No flash or voids molded were observed in the hub; however, dried blood and contrast were found within the hub.The marksman micro catheter body was found kinked at ~27.1cm, ~4.2cm and ~2.0cm from the distal end as well as directly proximal to the marker band.The marker band and distal tip was found intact.The marksman catheter was flushed; however, the micro catheter was found occluded as no water exited the distal end.A 0.0260¿ mandrel was then used for resistance testing.The mandrel became stuck at the hub and distal tip and could not be inserted into the micro catheter.The inner diameter could not be measured.Dried blood was found stuck within the micro catheter and further resistance testing could not be performed.No other anomalies were observed.Based on the analysis findings, the customer report of ¿lockup/resistance at distal segment of catheter¿ could not be confirmed.The customer report of ¿catheter resistance¿ was confirmed.T he cause of the resistance at time of analysis was the large amount of dried blood found within the catheter.Any other contributing factors for resistance could not be assessed as the catheter was found fully occluded by blood.The customer report of ¿catheter accordion¿ was not confirmed, however, the catheter was found to be kinked distally.From the damages seen on the pipeline flex pusher hypotube (stretch), separation of the distal wire from the hypotube and the catheter (kinking); it appears there was high force used.It is likely these damages occurred when the customer attempted to retract the pipeline flex through the marksman catheter against resistance.The end of the detached distal wire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end showed presence of tin (sn).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.The marksman catheter has a labeled inner diameter of 0.027¿ which is compatible for use with the pipeline flex.As the braid and distal delivery wire were not returned, any contribution of the braid or distal delivery wire could not be assessed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that after the marksman microcatheter was positioned, the pipeline became stuck and experienced resistance at the distal end during delivery.As a result, the entire system was withdrawn and the distal segment of catheter was accordioned.There was no pushwire damage, and the physician did not attempt to release the slack in the system.A new marksman and pipeline were used to complete the procedure with no issues.Angiographic results post-procedure showed slowed blood flow in the aneurysm.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms were reported.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the c4 with a max diameter of 5mm and a 2mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Ancillary devices include a navien guide catheter, cook long sheath.

• Brand Name: PIPELINE FLEX
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10446508
• MDR Text Key: 206580534
• Report Number: 2029214-2020-00832
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019751
• UDI-Public: 00847536019751
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: A918065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 08/23/2020
• Date Device Manufactured: 10/21/2019
• 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
• Patient Age: 64 YR