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

Model Number PED-400-25

Device Problems Difficult to Open or Close (2921); Activation Failure (3270)

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

Event Date 07/12/2018

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# = ped2-400-25 the pipeline flex with shield technology device has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, pipeline flex with shield technology device did not open at the distal end during a procedure.The patient underwent embolization treatment of left saccular unruptured internal carotid artery aneurysm, measuring 6.9mmx5.5mm, landing zone distal 3.6mm, proximal 3.8mm.Vessel tortuosity was described as severe.It was reported that during initial deployment, the pipeline device was unsheathed in the m1 section and observed the distal braid did not fully open.Device was resheathed and braid was unsheathed to around 1/3 of the braid, however still observed that distal braid did not fully open.The system was then dragged down to desired landing zone, just below junction of anterior cerebral artery (aca) and middle cerebral artery (mca), however braid did not open more, and system slipped from desired landing zone.Device was resheathed and again attempted to open in mca before dragging down to desired landing zone.However distal braid was still noted to appear constrained compared to proximal of braid that was unsheathed, hence physician decided to remove device.Upon removal, device was examined and noted to be compressed in a pencil tip shape at the distal portion.Afterward, a new pipeline flex with shield was deployed without issue.There were no reports of patient injury in association with this event.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned for evaluation and the clinical observation was confirmed.As received, the distal end of the pipeline flex shield braid was not opened, and braid was found damaged.The proximal end of the pipeline flex shield braid appeared to be fully opened and moderately frayed.No damages were found on the pushwire, the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based on the photo, the analysis findings and the event descriptions; we were unable to determine the cause of the failure to open at the distal end.The distal and middle part of the pipeline flex with shield were positioned in a bend.It is possible that the ¿patient¿s severe vessel tortuosity¿ and ¿damaged braid¿ may have contributed to the failure to open issue.The damage to the braid on the ends of the pipeline flex shield braid is likely the results of re-sheathing the device more than recommended two times.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex with shield has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex shield embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMOBOLIZATION 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: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7747296
• MDR Text Key: 116538151
• Report Number: 2029214-2018-00693
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2020
• Device Model Number: PED-400-25
• Device Lot Number: A439498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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