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

Model Number PED-425-18

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation.The device was not returned, therefore the reported event could not be confirmed.An event cause could not be conclusively determined from the reported information.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 pushwire of a pipeline flex broke during deployment.The patient was undergoing treatment for an unruptured aneurysm in the right internal carotid artery (ica).Vessel tortuosity was normal.The devices were prepared as indicated in the ifu.It was reported that the pipeline flex pushwire broke during deployment.Some resistance in the microcatheter was noted before pushwire break.It is not known how many times the pipeline flex had been deployed and resheathed.The physician does not know exactly what segment of the pushwire broke.The pipeline flex was removed from the patient by advancing the guide catheter.A new pipeline device of a smaller size was used to complete the procedure.The patient is reportedly fine and has been discharged from the hospital.

Manufacturer Narrative

The flow diverter and the catheter were returned for analysis.Approximately 0.5 cm of the flow diverter braid was found deployed outside of the catheter tip.The remaining braid and pushwire was found stuck inside the distal segment of the catheter.The flow diverter was pushed out of the catheter with difficulty.It appeared that the pushwire detached at the hypotube, proximal to the wire weld.The distal and proximal dps restraints were found intact.The dps sleeves were also found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal end of the flow diverter braid was found fully opened with slightly frayed; while the proximal end of the braid was found fully opened with no damage.Kinks and bends were found on the pushwire at the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.The surfaces (1 and 2) of the detached pushwire were then sent out for sem and eds analyses.Based on the reported event details, the analysis findings and the sem/eds analyses, the customer's report of ¿pushwire detach at hypotube proximal to the wire weld¿ was confirmed.The distal wire of the pipeline flex delivery system was possibly detached due to tensile failure.The damages seen on the returned catheter body (accordioning), proximal wire (kinking/bending) and hypotube (stretching); it appears there was excessive forced used (pushing and pulling.The elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted.Additionally, the proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).Design verification results showed that all the solder joints meet product specifications whereas existing process verification ensured that solder joints leaving the production line met product specification requirements.No evidence was found to suggest that the device failed to meet specifications.The lot history record of the reported lot number has been reviewed.The lot history record showed no discrepancies that would have contributed to the reported experience.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 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.¿ all products are 100% inspected for damage and irregularities during manufacture.

• 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; irivne, CA 92618 ; 9492753836
• MDR Report Key: 6035394
• MDR Text Key: 57685514
• Report Number: 2029214-2016-00906
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/14/2016

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: 04/04/2019
• Device Model Number: PED-425-18
• Device Lot Number: A254715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• 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