MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX WITH SHIELD; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-500-14

Device Problems Physical Resistance (2578); Activation Failure (3270)

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

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has been sent out for the device.Once we received the device and the evaluation has been completed, a supplemental report will be submitted.For the other device: reference mdr # 2029214-2018-00445 if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during and embolization treatment of an unruptured saccular aneurysm measuring in 8mm x 5mm located in the left internal carotid artery (ica) with severe tortuosity, two medtronic flow diverters could not be opened in the distal segments (the middle and proximal segments were open).The flow diverters were not positioned on a bend during the time of the event.The patient was on dual antiplatelet therapy (dapt).Both flow diverters were deployed approximately less than 50% when the failure occurred, and they were resheathed 1-2 times each.The physician attempted to open the distal segments by maneuvering the medtronic microcatheter and flow diverters until the flow diverters experienced resistance in the distal segment of the microcatheters and became trapped in the distal segment of the microcatheters.Both the flow diverters were resheathed and removed with the microcatheters from the patient.No patient injury was reported as a result of the procedures.The distal and proximal landing zones were 4.8mm x 4.8mm and the access vessel was the left ica with diameter of 4.8mm.

Manufacturer Narrative

The pipeline flex with shield stuck at the distal end of the catheter was returned for evaluation.For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with difficulty.A minimal amount of blood was observed inside the catheter lumen.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured within specifications.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex with shield braid fully opened and moderately frayed.The middle segment of the braid appeared to be fully opened and no damage.Kinks and bends were found on the pushwire near the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.From the damages seen on the proximal wire (kinking/bending), pipeline flex shield braid (fraying) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when attempted to navigate the pipeline flex with shield through the catheter against resistance.Additionally, the damage on both ends of the pipeline flex shield braid is likely the result of re-sheathing the device more than recommended two times.It is possible that the ¿severe vessel tortuosity¿ and "damaged braid" may have contributed to the failure to open and resistance during delivery.Based on the analysis findings and the event descriptions, the report of "failure to open" could not be confirmed as the returned pipeline flex with shield braid appeared to be fully opened and moderately frayed at both ends.It is possible that the "severe vessel tortuosity¿ and "damaged braid" may have contributed to the failure to open and resistance during delivery.From the damages seen on the proximal wire (kinking/bending), pipeline flex shield braid (fraying) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when the customer attempted to navigate the pipeline flex with shield through the micro catheter against resistance.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.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 intraluminal 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.¿ the investigation determined that this was a known event.Resistance during delivery and the patient tortuous anatomy are common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.All products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during an embolization treatment of an unruptured saccular aneurysm measuring in 8mm x 5mm located in the ophthalmic segment of the left internal carotid artery (ica) with severe tortuosity, two pipelines could not be opened in the distal segments (the middle and proximal segments were open).The pipelines were not positioned on a bend during the time of the event.The patient was on dual antiplatelet therapy (dapt).Both pipelines were deployed approximately less than 50% when the failure occurred, and they were resheathed 1-2 times each.The physician attempted to open the distal segments by maneuvering the marksman and pipeline until the pipelines experienced resistance in the distal segment of the marksman microcatheters and became trapped in the distal segment of the marksman microcatheters.Both the pipelines were resheathed and removed with the microcatheter from the patient.No patient injury was reported as a result of the procedures.The distal and proximal landing zones were 4.8mm x 4.8mm and the access vessel was the left ica with diameter of 4.8mm.There was report of the second marksman experiencing resistance in the distal segment of guide catheter at the end of navigation when they finalized the catheterization.They also noted that both pipelines and marksman have the same lot numbers and they have them together in the same package, so they were not able to differentiate the devices from one another.No damages were noted on the pipelines and microcatheters.The patient has a medical history of aneurysm that was treated in 2008 and had a late recanalization that required this recent treatment.Now has current headache.Ancillary devices: avigo guidewire, marksman 150cm microcatheter, neuron 6fr ¿ 0.070¿ guide catheter, neuronmax 8fr ¿ 90cm sheath.The reported devices and ancillary devices were reported to be prepared as indicated in the instructions for use (ifu).

• Brand Name: PIPELINE FLEX WITH SHIELD
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 7535040
• MDR Text Key: 108987960
• Report Number: 2029214-2018-00444
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: PED2-500-14
• Device Lot Number: A466075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR