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

Model Number PED2-375-16

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex delivery system was returned for evaluation.An in house 0.0265¿ mandrel was navigated in to the catheter and the mandrel became stuck within the catheter.The catheter was dissected, and a dps sleeve and pipeline braid with shield technology were found within the catheter lumen.The pipeline flex pushwire was observed to be separated into two segments (distal and proximal).The tip coil was observed to be stretched and one of the dps sleeves was noted to be separated from the pipeline flex delivery system.The braid was fully opened with the distal and proximal ends having slight fraying, and no damage to the middle section.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire was noted to have been bent near the distal tip coil and the separation was observed at 100.5cm from the distal tip coil.No other anomalies were observed.The broken proximal end of the distal segment of the pushwire was then cut and sent out for scanning electron microscopy (sem) analysis.Based on the analysis findings, sem analysis, and the reported event details, the report was confirmed.The returned device was observed to be damaged and separated.Based on the sem analysis, the failure mechanism for the separation was wire overload failure mechanism, as dimple features are visible.It is possible that the vessel tortuosity and catheter positioning may not have been adequately placed in a way that would have reduced slack which may have contributed to the reported issue.Based on the damages observed on the pipeline flex, it appears that excessive force was used (pushing <(>&<)> pulling).Per our instructions for use (ifu): ¿using standard interventional radiographic technique, 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 with shield technology.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 with shield technology against resistance may result in damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the catheter against resistance may result in damage to the 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.

Event Description

Medtronic received information that during treatment of an aneurysm located in the ophthalmic segment of the left internal carotid artery, the pipeline flex with shield device and the microcatheter "jumped" into the aneurysm.It was reported that this occurred during positioning and opening of the stent.The physician reports that the catheter did not provide enough support across the aneurysm neck.The physician decided removed the entire system from the patient and found that the device became stuck within the microcatheter and therefore could not be repositioned.The aneurysm was unruptured and saccular.The patient had moderate vessel tortuosity.The pipeline and accessory devices were prepared as indicated in the ifu.

• 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 ; 9492753836
• MDR Report Key: 6807131
• MDR Text Key: 83134462
• Report Number: 2029214-2017-00981
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: PED2-375-16
• Device Lot Number: A343122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• 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: 49 YR
• Patient Weight: 65