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

Model Number PED-425-16

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex braid will not be returned as it was implanted in the patient; the delivery system has not been returned for evaluation.The delivery system was not returned, therefore the reported event could not be confirmed.An event cause could not be conclusively determined from the reported information.D.Suspect medical device brand name: pipeline flex with shield technology model number: ped2-425-16.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the delivery system of a pipeline flex with shield detached proximal to the proximal marker.The patient was undergoing treatment for three unruptured, amorphous aneurysms in the left internal carotid artery (ica).Two aneurysms were in the paraclinoid segment and one was in the paraophthalmic segment.The aneurysms had a max.Diameter was 4mm and neck diameter of 2mm.The landing zone artery size was 3.79mm distal and 4.2mm proximal.Vessel tortuosity was normal.The devices were prepared as indicated in the ifu.It was reported that the pipeline flex with shield braid was deployed in the patient without any issues.The microcatheter was advanced over the delivery wire and through the braid to recapture the distal coil; the physician reported feeling a ¿click¿ when the distal tip of the microcatheter reached the ptfe sleeves.The physician noted that there was no extra force applied at this point.The physician then tried to pull the tip coil into the microcatheter; the delivery wire was pulled from the patient while the proximal marker to the tip coil of the delivery system remained in the patient.The physician was able to see angiographically and physically that the delivery system had detached at the point proximal to the proximal marker.The ptfe sleeves had not been recaptured into the microcatheter.Aspiration on the microcatheter was used to bring what was left of the delivery system into the guide catheter.The ptfe sleeves then got stuck on the distal end of the guide catheter.The microcatheter and what was left of the delivery system at this point became detached from each other.The detached part of the delivery system was now stuck on the distal end of the guide and the microcatheter was removed from the guide catheter.The physician then applied aspiration to the guiding catheter; what was left of the delivery system was aspirated into the guide and removed from the patient.The ptfe sleeves were intact on inspection once removed from the patient.There were no reports of patient injury in connection with this event.

Manufacturer Narrative

Device evaluation the pipeline flex pushwire was returned for evaluation with the catheter.The braid was not returned as it was implanted in the patient.As received, the pipeline flex pushwire was outside of the catheter.The pipeline flex pushwire was found to be detached at the hypotube proximal to the wire weld.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends were found on the pushwire at a section near the proximal end.The surfaces of the detached pushwire were sent out for scanning electron microscopy (sem) and energy dispersive spectroscopy (eds) analyses.Based on the customer¿s photos, event details, analysis findings, and sem/eds analyses, the report of pipeline flex pushwire detachment was confirmed.The distal wire of the pipeline flex delivery system possibly detached due to tensile failure.A review of the manufacturing process did not uncover any deficiencies in regards to the soldering process.The elemental analysis conducted through sem and eds showed presence of soldering material indicating that soldering was conducted.Additionally, a proof load is performed on 100% of the devices.The lot history record of the reported lot number of the pipeline flex has been reviewed.The lot history record review showed no discrepancies that would have contributed to the reported experience.All products are 100% inspected for damage and irregularities during manufacture.The damages seen on the returned catheter body (accordioning), proximal wire (kinking/bending) and hypotube (stretching) suggest that excessive force was used (pushing and pulling).It is possible that the excessive force used may have contributed to the detachment issue during retrieval.Per our instructions for use: "discontinue delivery of the device if high force or excessive friction is encountered.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 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 micro catheter against resistance may result in damage to the micro catheter, or the vessel.¿.

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: 6019380
• MDR Text Key: 57099250
• Report Number: 2029214-2016-00889
• 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,Followup
• Report Date: 09/15/2016

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: 04/06/2018
• Device Model Number: PED-425-16
• Device Lot Number: A085492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided; 01/20/2017
• Supplement Dates FDA Received: 01/26/2017; 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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: 51 YR
• Patient Weight: 69