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

Model Number PED-450-18

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex pushwire and marksman catheter were returned for evaluation without the pipeline braid.It was confirmed that the pipeline flex pushwire was detached at hypotube, proximal to the wire weld.The distal segment of the pushwire was found outside the catheter and the proximal segment of the pushwire was found inside the catheter lumen.For further examination, the remained proximal segment of the pushwire was then pushed outside of the catheter lumen with difficulty.A minimal amount of blood was observed inside the catheter lumen.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire appeared to be bent at 31.5 cm to 35.5 cm from 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 surface of the detached pushwire was then sent out for scanning electron microscopy with energy dispersive x-ray spectroscopy analysis (sem-eds).Based on the reported event details, the analysis findings and the sem/eds analyses, the customer's report was confirmed.It is suspected that the tensile overload exceeded the strength of the solder joint.Severe vessel tortuosity may have contributed to the ¿great resistance¿ during delivery; subsequently causing the pipeline flex delivery system and catheter to become damaged and detached.However, the cause for the resistance could not be determined.Additionally, the damages seen on the proximal wire (bending), hypotube (stretching) and catheter (accordion); it appears there was excessive forced used (pushing and pulling).Per the instructions for use, the user should "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.¿ the lot history record of the reported lot number showed no quality issues against the lot and no other anomalies were found during the document review.All products are 100% inspected for damage and irregularities during manufacture.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 a report that the physician had difficulty delivering the pipeline flex through the microcatheter, and upon removal found a wire like object in the catheter.The aneurysm to be treated was an unruptured saccular aneurysm, which was not previously coiled.The neck width was 5mm, the proximal landing zone was 4.6mm and the distal landing zone was 4.4mm.The physician deployed the flow diverter (pipeline) at m1.The target location was the right ic-paraclinoid.Based on the risk of advancing the marksman, the physician decided to remove the pipeline system with the marksman microcatheter.The pipeline system and marksman were pulled back inside the navien to remove from the patient.After removal of the marksman and pipeline from the navien, the physician started taking images in order to start coil embolization (jailing technique).At this time, the physician found a wire like object left inside the navien.The navien catheter was removed from the patient and the physician noted that the tip of the pipeline system had broken and was left inside of the navien.The broken piece was located inside the navien catheter and was never in the patient¿s vessel.The device was broken at the proximal resheath pad.No intervention was required and no patient issue has been reported.The procedure was completed by coiling the aneurysm as originally planned.

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): 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: 5879790
• MDR Text Key: 52719157
• Report Number: 2029214-2016-00730
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/21/2016

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: 10/21/2018
• Device Model Number: PED-450-18
• Device Lot Number: A177060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: 07/21/2016
• Supplement Dates FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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: 47 YR