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

Model Number PED-475-25

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex was returned for evaluation with the catheter.As received, the pipeline flex delivery system was stuck inside the distal segment of the catheter.For further examination, the pipeline flex delivery system was pushed out of the catheter lumen with difficulty.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.The pushwire was found to be bent near the distal tip coil.Kinks and bends were also found on the pushwire at a section near the proximal end.The distal and proximal ends of the pipeline flex braid were found fully opened and slightly frayed.The surfaces of the detached pushwire were sent out for scanning electron microscopy (sem) and energy dispersive x-ray spectroscopy (eds) analyses.Evaluation is still in progress.A follow-up mdr will be submitted when evaluation is complete.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 of pipeline flex pushwire separation during a procedure.The patient was undergoing retreatment of a cerebral aneurysm in the left cavernous internal carotid artery (ica).Aneurysm size was 10 mm.The vessel had medium-level tortuosity.The devices were prepared as indicated in the ifu.It was reported that during the procedure, the physician pushed the pipeline flex push wire in order to remove the protection sleeve in the middle cerebral artery (mca) and tried to resheath.However, high resistance was experienced and the pushwire separated.The pipeline flex had been resheathed two times.The pipeline flex was removed from the patient with the catheter.A new pipeline flex was used to complete the procedure.There were no reports of patient injury in connection with this event.

Manufacturer Narrative

Based on the reported event details, gross analysis, as well as scanning electron microscoscopy (sem) and energy dispersive x-ray spectroscopy (eds) analyses, the reports of pipeline flex pushwire detachment at the hypotube proximal to the wire weld was confirmed.The distal wire of the pipeline flex delivery system possibly detached due to tensile failure.Based on the damage observed on the d istal/proximal wire (kinking/bending), pipeline flex braid (fraying) and hypotube (stretching), it appears that excessive forced used (pushing and pulling).In addition, user context may have contributed to the reported issues as the physician continued to advance /retrieve the pipeline flex delivery system despite high resistance.It is possible that the patient¿s moderate vessel tortuosity may have contributed to the reported resistance, subsequently causing the devices to become damaged.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.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.¿ a review of our manufacturing process did not uncover any deficiencies in regards to the soldering process.In addition, the elemental analysis conducted through sem and eds showed presence of soldering material indicating that soldering was conducted.The lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.All products are 100% inspected for damage and irregularities during manufacture.

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: 6301372
• MDR Text Key: 66519116
• Report Number: 2029214-2017-00083
• 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,Followup
• Report Date: 01/11/2017

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: 05/19/2019
• Device Model Number: PED-475-25
• Device Lot Number: A280231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided; 02/07/2017
• Supplement Dates FDA Received: 03/02/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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: 79 YR