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

Model Number PED-375-25

Device Problem Break (1069)

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

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

As the device was received in a condition was contradictory to the complaint description.As received, the pushwire was found broken distal to the resheathing marker.This condition was not reported at the time of the event.As received, the pipeline flex pushwire hypotube was found kinked from the proximal end.The hypotube was found stretched for the distal section.The ptfe jacket was found accordioned at the proximal end of the pushwire.The pushwire was found broken distal to the resheathing marker.The distal marker, dps restraints, dps sleeves, tip coil, distal marker found to be missing.The braid was returned already detached and fully opened with both ends slightly frayed.The broken end of the pushwire was sent out for sem (scanning electron micrographic) analyses.Based on the analysis findings, the fracture features observed indicate a torsional overload failure, which confirms the high force used against resistance.From the damages seen on the pipeline flex braid (frayed ends), pushwire (kinking/stretching), and ptfe jacket (accordioning); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retract the pipeline flex through the marksman catheter against resistance.Possible contributors for resistance are: patient vessel tortuosity or lack of continuous flush during delivery.Customer reported patient vessel tortuosity as severe.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the first pipeline flex was released approximately half way out of the first marksman microcatheter when the resistance became too hard to release any more of it.The physician attempted to withdraw the pipeline but failed so the pipeline flex and marksman were both withdrawn as a whole system.The physician replaced them with a new pipeline flex (ped-375-30) and marksman but discovered that the distal end of the microcatheter was severely accordioned and the tip of the new pipeline flex was deformed.The second pipeline and marksman were replaced with a new flow diverter and microcatheter to complete the operation successfully.No patient injury was reported as a result of the event.Post procedural angiography showed slow blood flow.The patient was undergoing embolization treatment of an unruptured fusiform aneurysm measuring 4.28mm x 9.77mm located in the left middle cerebral artery.The distal and proximal landing zone was 2.6mm x 3.76mm and the vasculature was severe in tortuosity.Evaluation of the returned device found that the pushwire was found broken distal to the resheathing marker.

• Brand Name: PIPELINE FLEX EMOBLIZATION DEVICE
• 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: 9451286
• MDR Text Key: 206521076
• Report Number: 2029214-2019-01218
• Device Sequence Number: 1
• Product Code: OUT
• 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: Physician
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: PED-375-25
• Device Lot Number: A848677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2019
• 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
• Patient Age: 57 YR