MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-450-14

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

Patient Problems Paresis (1998); Foreign Body In Patient (2687)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

The reported device has not been received.The product was not evaluated, therefore the reported event could not be confirmed.The cause of the event could not be conclusively determined from the available information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a pipeline flex device broke at the hypotube during a flow diversion treatment procedure.During resheathing of the pipeline for the second time, part of the hypotube broke and detached from the pushwire.The wire (hypotube) broke proximal to proximal bumper when the pipeline was about 50% outside of the microcatheter tip.The physician tried to withdraw the pipeline back into the microcatheter but was unsuccessful.The physician decided to deploy the pipeline.After deployment, the pipeline was partially open at the distal segment and closed at proximal segment.Several unsuccessful attempts were made to snare the device.Then a balloon catheter was introduced to open the pipeline.The physician managed to partially open the device from across the acom (anterior communicating artery).Attempts were made to snare the device again but failed to retrieve it.The broken wire (hypotube) and pipeline remained in the patient.Post op imaging showed the pipeline with full wall apposition.The reported pipeline flex was used to treat the patient's saccular aneurysm located at the superior hypophyseal segment of the ica (internal carotid artery).The maximum diameter was 4.5mm and neck diameter was 3mm.The distal and proximal diameters of the artery landing zone were 3.8mm and 4.44mm respectively.The patient's vessel tortuosity was described as minimal.The detached hypotube and partially opened pipeline remained in the patient's ica.Post op imaging showed all vessels were open.The pipeline well apposed to vessel wall.The patient had right-sided weakness post operatively.It was reported the device was prepared following the ifu (instructions for use).The patient have been on dapt (dual antiplatelet therapy).

Manufacturer Narrative

Additional information was received via user facility medwatch form.(b)(4).Correction: sex; female.Additional information: weight in lbs: (b)(6) lbs.Dec evt problem: additional information received from user facility.Rpt.Sent to fda? yes.The user facility reported 198 cm of 204 cm pipeline wire removed.User facility checked.If information is provided in the future, a supplemental report will be issued.

Event Description

After multiple unsuccessful attempts to retrieve the wire, it was reported that 198 cm of 204 cm of the pipeline wire were removed.

Manufacturer Narrative

Device available, return date - additional information.Device evaluated - additional information.Evaluation codes - additional information, device evaluation.Additional manufacturer narrative - additional information, device evaluation a visual and photographic examination of the pipeline flex pushwire was performed.The pushwire was found to be kinked, bent and separated at the distal hypotube.In addition, the hypotube was found to be severely stretched.The broken end of the pushwire was then sent out for scanning electron microscopy (sem) analysis.The pipeline braid remains inside the patient.Therefore, device evaluation regarding the report of "partially opening" was not possible and could not be confirmed.A possible contributing factor to the pipeline braid partially opening may be a combination of patient anatomy and device delivery technique.Based on the reported event details, analysis findings, and the sem analysis; the clinical observation of pushwire separation was confirmed and was determined to be due to tensile overload failure.A review of lot history records showed that the finished device met all manufacturing requirements and specifications during final assembly and quality inspection.There was no indication that the event of pushwire separation was attributed to the device.All products are 100% inspected for damages and irregularities at manufacturing.Therefore, manufacturing has been ruled out as a potential cause.Per pipeline flex device 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 microcatheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.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 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.The pipeline flex shield embolization device is fully resheathed when the distal marker is retracted completely inside the micro catheter.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• 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: 6874636
• MDR Text Key: 86561922
• Report Number: 2029214-2017-01064
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: PED-450-14
• Device Lot Number: A465049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 08/24/2017; 10/10/2017
• Supplement Dates FDA Received: 09/27/2017; 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2017
• 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 Outcome(s): Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 83