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

Model Number PED-500-35

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex braid remains implanted in the patient; the pipeline flex delivery system has not been returned for evaluation, therefore the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a pipeline flex embolization (ped) braid migrated into the aneurysm sac after placement during a flow diversion procedure.The device was used to treat a patient's amorphous cerebral aneurysm located at the cavernous segment of the internal carotid artery.The aneurysm had max diameter of 13 mm and a neck width of 5.1 mm.The parent artery landing zones measured 4.7 mm distally and 5.1 mm proximally.Vessel tortuosity was described as moderate.It was reported the ped was prepared as indicated in the instructions for use.The microcatheter was delivered to m1 segment of the middle cerebral artery.The ped was advanced to the targeted deployment position.When distal segment of the ped was opposed at targeted landing zone, and proximal landing zone was determined, the ped braid was gently unsheathed past the aneurysm neck.When good wall opposing was achieved, the entire ped was released.After the ped braid was deployed, fluoroscopy showed the ped distal segment had migrated into the aneurysm sac.The physician attempted to use a microcatheter and guide wire to reposition ped.During this process, the proximal end of the ped migrated into the aneurysm sac as well.At this point, all systems were removed from the patient and procedure discontinued.No patient injury report.

Manufacturer Narrative

Additional information, device evaluation the delivery wire of the reported ped was received and evaluated.Upon examination, no damages or anomalies were observed.The reported pipeline flex embolization device (ped) braid remains implanted inside the patient and could not be evaluated.No images were provided for review.Based on the device analysis findings, the report of ped migration after deployment could not be confirmed and the cause of the clinical observation could not be determined.Possible contributing factor of ¿migration after deployment¿ includes pushing delivery wire without retracting the micro catheter at the same time during the deployment of the ped braid, which will cause the open end braid to move distally in the vessel.The ped instruction for use states " ¿place the micro catheter tip at least 20 mm past the distal edge of the aneurysm.Gently retract the micro catheter to reduce slack in the micro catheter prior to inserting pipeline flex embolization device.Pushing delivery wire without retracting the micro catheter at the same time will cause the open end braid to move distally in the vessel.Do not use the pipeline flex embolization device in vessel diameters that are larger than the labeled diameter.Select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration.¿ all products are 100% inspected for damage and irregularities during manufacture.No evidence was found to suggest that the reported ped failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause.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: 7239383
• MDR Text Key: 99199017
• Report Number: 2029214-2018-00083
• 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,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: PED-500-35
• Device Lot Number: A568390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• 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