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

Model Number PED-400-18

Device Problem Activation Failure (3270)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex delivery system was returned for evaluation.The pipeline braid was not attached to the pushwire; therefore the distal and proximal ends of the braid could not be determined.The pipeline braid was found fully opened with moderately fraying on both ends.No other anomalies were observed.Based on the analysis finding the clinical observation could not be confirmed.The cause for the reported experience could not be determined.It is possible that the patient anatomy and damaged braid may have contributed to the device not opening.However, the cause for damage could not be determined.Per our instructions for use (ifu), the user should ¿discontinue delivery of the device if high force or excessive friction is encountered 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¿.Suspect medical device brand name = pipeline flex w/shield technology, model # = ped2-400-18.Information received from the same report as mfr: 2029214-2016-00601.

Event Description

Medtronic received information that during treatment of a saccular aneurysm in the supraclinoid segment of the left internal carotid artery (ica), two devices did not open during deployment.It was reported that the microcatheter was navigated up into middle cerebral artery (mca) beyond the aneurysm and the first device (ped2-400-18) did not open during advancement.It was noted that the device "flared" then failed to continue to open.The physician resheathed and removed the device.A second device (ped-400-20) with new microcatheter was introduced, deployed in m1 segment and the entire system was drawn back to communicating segment of the internal carotid artery (ica).The device was then deployed across aneurysm neck and an inferior amount of the device did not appose the vessel wall.Attempts were made to alter the tension in the system and the physician continued to deploy around clinoid bend; however the device still did not open.There was a moderate amount of resistance noted during advancement of the device.It was further reported that vessel stenosis was proximal to (ica).The entire system was removed and the was case abandoned.The patient was also reported to have psychological harm.

Manufacturer Narrative

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): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5811043
• MDR Text Key: 50073838
• Report Number: 2029214-2016-00600
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/23/2018
• Device Model Number: PED-400-18
• Device Lot Number: A151295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• 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