MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-18

Device Problems Break (1069); Activation Failure (3270)

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

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This is a report for a similar device that is not marketed in the us.Suspect medical device - similar device brand name = pipeline flex w/shield technology model # = ped2-475-35.The device has not been received for evaluation.Therefore, the cause of this incident cannot be conclusively determined with available information.Additional information has been requested.Should the device be received for evaluation or additional information available, a supplemental report will be filed.

Event Description

Medtronic received information that the distal segment of the pipeline flex with shield technology device (ped2) failed to open during flow diversion procedure.It was also reported the middle segment of the ped2 pushwire broke.The ped2 was used to treat a patient's fusiform aneurysm located at the right internal carotid artery.The aneurysm had max diameter of 6.2mm with neck width of 5.9mm.Landing zone artery sizes were 4.3mm distally and 4.5mm proximally.Vessel tortuosity was described as severe.It was reported the device was prepared as indicated in instruction for use.During the delivery of the ped2, resistance was met inside the microcatheter.The distal segment of the ped2 was placed at a bend and it was unsheathed and resheathed for more than 2 times.Less than 50% of the ped2 was deployed and the distal segment of the ped2 failed to open.The ped2 was resheathed inside the microcatheter.It was noted that the pushwire of the ped2 broke at its middle segment.The broken segment and the rest of the pushwire was removed with the microcatheter.Treatment for the patient was completed with a new device.No patient injury reported.

Manufacturer Narrative

Additional information received.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The pipeline flex with shield was returned with the microcatheter.The pipeline device was found to be stuck inside the microcatheter.The pipeline flex with shield could not be pushed forward or removed.For further examination, the catheter was then cut to remove the pipeline flex with shield.The pushwire was found to be separated into two segments (distal and proximal).The distal and proximal dps restraints were found to be intact.The dps sleeves were found to be intact with no signs of damage.The pushwire was appeared to be separated at the distal tip coil (proximal to the dps sleeves).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 were found fully opened with moderately frayed.The pushwire was found to be bent near the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The broken end of the pushwire was then sent out for scanning electron microscopy (sem) analysis.No other anomalies were observed.Based on the analysis findings, the event description and the sem analysis; the report of pushwire separation was confirmed, as the pipeline flex with shield pushwire was found to be separated and stuck inside the catheter lumen.The facture surface exhibits ductile features indicative of torsional overload failure.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 patient¿s vessel tortuosity was severe, and the devices were prepared per the ifu.It is possible that the ¿severe vessel tortuosity¿ may have contributed to the reported issues.From the damages seen on the c 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 user continued to advance/retrieve the pipeline flex with shield through the microcatheter.Per our instructions for use (ifu): the user should: discontinue delivery of the device if high force or excessive friction is encou ntered 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 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.Regarding the ¿failure to open at the distal end¿ issue, the complaint could not be confirmed, as the distal end of the returned pipeline flex with shield braid was found fully opened with moderately frayed.Additionally, the proximal end of the pipeline flex shield braid was also found fully opened with moderately frayed.The reported that ¿the device was placed on a bend.The device was deployed less than 50% and was resheathed more than two times.¿ it is possible that the ¿severe vessel tortuosity¿ may have contributed to the ¿failure to open¿ issue.Additionally, it is not recommended to initiate deployment of the device on a bend.Furthermore, the damage to the braid on both ends of the pipeline is possibly the result of the user resheathing the device more than the recommended two times.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.The system is designed to allow for 2 full cycles of resheathing of the pipeline flex embolization device.Resheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.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.All products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN, IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN, IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7129712
• MDR Text Key: 95338442
• Report Number: 2029214-2017-01367
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Model Number: PED-500-18
• Device Lot Number: A491480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/04/2018; 01/04/2018
• Supplement Dates FDA Received: 01/08/2018; 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• 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: 49 YR
• Patient Weight: 75