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

Model Number PED2-375-18

Device Problems Positioning Failure (1158); Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex pusher was returned for analysis.No bends or kinks were found with the pipeline flex pusher.The distal hypotube was found stretched with the ptfe shrink tubing pulled back.The pusher was found detached at the distal hypotube weld (solder joint).The pipeline flex distal segment (resheathing pad/marker, braid, ptfe sleeves, distal marker, and tip coil) were found detached and not returned.The pipeline flex braid ends were found damaged (frayed).No other anomalies were observed.Based on the device analysis and reported information, the customer¿s reports of ¿catheter kick back¿, ¿difficult placement/positioning¿, and ¿resistance/stuck during delivery¿ could not be confirmed.The phenom catheter used in the event was not returned.Therefore, analysis could not be performed and conformance to specification could not be assessed.The investigation determined that this event was similar to an event 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 braid became damaged and the pusher became stretched due to the reported resistance.However, the cause for the resistance could not be determined.Regarding the solder joint separation issue, separation can occur due to excessive force or inadequate solder/tinning.The pipeline flex distal segment was found detached and not returned.Therefore, analysis could not be performed an d conformance to specification could not be assessed.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.The investigation determined that this event is similar to events that had already been investigated, and another investigation is not necessary.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was resistance when introducing the pipeline, and possible kinking of the phenom microcatheter.Upon delivering the pipeline to the distal landing zone, the catheter led to a kickback and the pipeline missed the target location.The procedure had to be completed with another device.There was no patient injury as a result of the event.The patient was undergoing treatment for aneurysm located in the left ophthalmic artery.It was irregularly shaped, and 5-6 mm in diameter, the patient's vessel tortuosity was moderate.The devices had been prepared according to the instructions for use, and a continuous flush was administered during the procedure.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10787138
• MDR Text Key: 214632485
• Report Number: 2029214-2020-01095
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AE
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: PED2-375-18
• Device Catalogue Number: PED2-375-18
• Device Lot Number: A815079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• 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