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

Model Number PED-350-35

Device Problem Material Fragmentation (1261)

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

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

As the pipeline flex device was received for analysis found that the pipeline flex embolization device was returned within a non-medtronic micro catheter.The pipeline flex pusher was found protruding from within the non-medtronic micro catheter catheter hub.No bends or kinks were found with the headway 27 catheter body.No damages were found with the non-medtronic micro catheter distal marker/tip.The pipeline flex tip coil was found protruding from within the non-medtronic micro catheter catheter distal tip.The tip coil ball weld was found missing.The pipeline flex embolization device was pushed out from within the non-medtronic micro catheter micro catheter without issue, deploying the braid.The pipeline flex braid ends were found fully open and in good condition.The distal hypotube and ptfe shrink tubing was intact with no signs of elongation.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, or distal marker.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found damaged.No other anomalies were observed.Based on the device analysis and reported information, we were unable to determined the cause of the tip coil separated.It is possible that there was force used (pushing and pulling).It is likely these damages occurred when the customer attempted to navigate the pipeline flex through the micro catheter against resistance.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that first pipeline flex device felt resistance in the catheter.The patient was undergoing embolization treatment for ruptured fusiform right vertebral artery fusiform aneurysm, measuring 3.2mmx11mm and landing zone distal 2.9mm proximal 3.25mm.The vessel was observed moderately tortuous.It was reported that while pushing pipeline through non-medtronic catheter and lot of resistance was coming and due to resistance, it was being difficult to place device, with resistance device also fallen down inside aneurysm so doctor decided not to use this device and used another pipeline for finish procedure.There were not any patient symptoms or complications associated with this event.No patient injury was reported.The angiographic result post procedure shows slow flow evaluation of the returned device found that tip coil ball weld was found missing from the pipeline flex device.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9772699
• MDR Text Key: 182171292
• Report Number: 2029214-2020-00178
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial
• Report Date: 03/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-350-35
• Device Lot Number: A688683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 57 YR
• Patient Weight: 63