MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-450-35

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

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

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has been returned and evaluation is in progress.A follow-up mdr will be submitted when device investigation is complete.

Event Description

Medtronic received report that a pipeline flex did not open during a procedure.The patient was undergoing flow diversion treatment for a giant aneurysm in the left internal carotid artery (c2 to c4).The aneurysm was 20mm.Vessel tortuosity was moderate.The devices were prepared as indicated in the ifu.It was reported that the microcatheter and guidewire was delivered to the distal m1 middle cerebral artery (mca).The pipeline flex was delivered through the microcatheter with resistance.The physician still managed to advance the pipeline flex to the marker on the microcatheter tip.On deployment, the pipeline flex did not open.The physician attempted to push and pull the pipeline flex, but it could not be moved.The pipeline flex and microcatheter were removed from the patient together.The procedure was completed using a new pipeline flex.There was no report of patient injury in connection with this event.

Manufacturer Narrative

Additional information, device evaluation the pipeline flex delivery system was returned for evaluation with the catheter.As received, the distal segment of the pipeline flex braid was found partially deployed outside of the catheter tip.The remainder of the braid as well as the pushwire were found stuck inside the distal segment of the catheter.For further examination, the catheter was dissected to remove the pipeline flex delivery system.The distal hypotube appeared to be stretched with ptfe shrink tubing still intact.The pushwire was found to be bent near the proximal end.The distal end of the pipeline flex braid was found fully open with moderate fraying while the proximal end was found fully open with no damage.Based on the analysis findings and event description, the report of pipeline flex failure to open at the distal end could not be confirmed.It is possible that the patient¿s moderate vessel tortuosity and damage to the braid may have contributed to the failure to open issue.The damage observed on the catheter body (accordioning), proximal wire (bending), pipeline flex braid (fraying) and hypotube (stretching) suggest that excessive force used.In this event, the user context may have contributed to the reported issues as the physician continued to advance the pipeline flex delivery system despite the resistance.However, the cause for damage could not be conclusively determined.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 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.¿ all products are 100% inspected for damage and irregularities during manufacture.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: 6229265
• MDR Text Key: 64065292
• Report Number: 2029214-2017-00021
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2018
• Device Model Number: PED-450-35
• Device Lot Number: A150539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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: 66 YR