MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-450-20

Device Problem Activation Failure (3270)

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not be received for evaluation.Therefore, the clinical observation cannot be conclusively determined at this time.Should the device be received.Evaluation will be performed and additional information will be submitted in a supplemental report.

Event Description

Medtronic received information that a pipeline flex with shield device did not open at the distal segment during a flow diversion procedure.The reported device was used to treat a patient's right internal carotid artery fusiform aneurysm measured 4.6mm in max diameter with neck width of 7.1 diameter.The distal and proximal landing zone diameters were 4.3mm and 4.6mm respectively.Vessel tortuosity was reported as moderate.It was reported the device was prepared following the instruction for use and the microcatheter was flushed continuously with heparinized saline during the procedure.The pipeline flex device encountered friction at the distal segment of the microcatheter.When attempted to deploy the pipeline flex with shield braid at a bend, the braid would not open.The physician attempted to resheath the device, but the microcatheter would not advance.The pipeline flex with shield device was stuck at the distal segment of the microcatheter.The physician then attempted to deployed more of the pipeline flex with shield braid, which started to flatten.With some force, the physician was able to resheathed the entire pipeline flex with shield device into the microcatheter.This set of pipeline flex devices and microcatheter were removed from the patient.New flow diverter and microcatheter were used to complete the flow diversion treatment for the patient with perfect post procedural angiographic results.No injury reported.

Manufacturer Narrative

Additional information, device evaluation the device was received for evaluation.The reported pipeline flex with shield technology (ped2) device was received stuck within a microcatheter.When the ped2 was pushed out of the microcatheter for further examination, the ped2 braid was found fully opened.The report of ped2 did not open at the distal segment was not confirmed.Moderate fraying was noticed at both the distal and proximal end of the this ped2 braid.The delivery wire of the ped2 was also noted to have stretched distal hypotube and bent at 29.5cm from the proximal end.No other anomalies were observed.Based on the device analysis, the observed damages on the ped2 most likely happened when high force or excessive friction encountered during delivery and retrieval of the ped2.The patient's moderately tortuous anatomy could have contributed to friction and need for high force.The ped2 instruction for use states" caution: if high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously.Advancement of the pipeline¿ flex embolization device against resistance may result in damage or patient injury." all devices are 100% inspected for damage and irregularities during manufacture.No evidence was found to suggest that the devices 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 W/SHIELD TECHNOLOGY
• 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: 7143466
• MDR Text Key: 95793576
• Report Number: 2029214-2017-01375
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: PED2-450-20
• Device Lot Number: A402539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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