MAUDE Adverse Event Report: MEDTRONIC COVIDIEN 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 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex pushwire and the microcatheter were returned.The pipeline flex pushwire was found outside of the microcatheter.The pipeline braid was not returned as it was implanted in the patient.It was confirmed that the pipeline flex pushwire was 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 also observed to be bent.The microcatheter was found to have accordion damage.No other anomalies were observed.The surfaces of the detached push wire were sent for sem (scanning electron microscope) and eds (energy dispersive spectroscopy) analyses.Based on the analysis findings, the clinical observation was confirmed.It appears that the distal wire was secondary to tensile failure.We are unable to definitively determine for the tensile failure.The damages seen on the returned proximal wire, hypotube and catheter body suggest excessive forced was used such as pushing and pulling.The elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material; thereby indicating that the soldering was conducted.In addition, a review of this device lot history record was conducted and no issues were identified that could have contributed to this event.All products are 100% inspected for damage and irregularities during manufacture.Per our 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.

Event Description

Medtronic received information that during treatment of an aneurysm, located in the left cavernous segment of the internal carotid artery the push wire tip coil detached distal of the hypotube with the ptfe sleeves still attached.It was reported that the pipeline was implanted successfully; however when the microcatheter was used to withdraw the push wire tip coil, resistance was felt.The pipeline and microcatheter were then withdrawn together from the patient and the tip coil was discovered to be separated.The tip coil was still within the microcatheter and removed from the patient successfully.There was no report of patient injury.

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): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6001946
• MDR Text Key: 56550822
• Report Number: 2029214-2016-00875
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/07/2016

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 Model Number: PED-450-18
• Device Lot Number: A111003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: 09/07/2016
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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