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

Model Number PED-400-12

Device Problems Break (1069); Physical Resistance (2578); Detachment of Device or Device Component (2907)

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

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.Once complete a supplemental report will be submitted.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 information that the physician attempted to resheath or make the device open distally, but was not successful.There was severe resistance in the microcatheter.Both pipeline and micro catheter were removed with no issue or injury to the patient.The patient was receiving treatment for an unruptured saccular aneurysm in the left ica.The access vessel was the rt femoral and was 3.5 mm in diameter.The max diameter of the aneurysm is 5 mm and the neck diameter is 10 mm.The distal landing zone was 3.75 mm and the proximal landing zone was 4.0 mm.The patient had severe vessel tortuosity.The pipeline, microcatheter, and all ancillary devices were prepared per the ifu and the catheter was flushed continuously with heparinized saline.There was severe resistance when attempting to resheath the pipeline in the microcatheter and the pipeline locked up.There was gradual resistance building up before it became stuck.The physician tried to resheath the pipeline twice to make it open distally but it did not open or resheath.The distal section of the pipeline would not open; no additional steps were taken to open it.On the second resheath attempt, the pipeline inadvertently detached from the pushwire.The physician decided to remove everything because of the partially opened ped and the unresponsive attempts to open completely.No additional steps were made to open the pipeline and it was removed from the patient with the catheter.The pipeline was not positioned in a bend.Less than 50% had been deployed when it failed to open.There was resistance when removing the microcatheter due to anatomy of the patient and the recapturing of the partially opened ped.Once removed, the push wire was observed to be broken at the distal end.All components were removed from the patient through the microcatheter.The procedure was completed with a new micro catheter and a different sized pipeline device.

Manufacturer Narrative

Device evaluation the pipeline flex delivery system and the micro catheter were returned for evaluation with the pipeline flex delivery system outside of the microcatheter.The pipeline braid was not attached to the pushwire.The pipeline flex pushwire was found to be detached at the hypotube proximal to the wire weld.The distal and proximal dps restraints were found intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends were found on the pushwire at 30.0 cm to 45.5 cm from the proximal end.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.Both ends of the pipeline braid were found fully opened and frayed.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.All devices are 100% inspected for damage and irregularities during the manufacturing process.Based on the reported event details, the analysis findings and sem/eds analyses, the reported events were confirmed as the received pipeline flex pushwire was found to be detached at the hypotube proximal to the wire weld.The distal wire of the pipeline flex delivery system was possibly detached due to tensile failure.The damages seen on the returned device indicate excessive forced used (pushing and pulling).It is possible that the ¿severe vessel tortuosity¿ may have contributed to the reported resistance during delivery; subsequently causing the devices to become damaged.In this event, the user context may have contributed to the reported issues as the physician continued to advance the pipeline flex delivery system despite resistance.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.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.¿.

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 ; 9498373700
• MDR Report Key: 6232667
• MDR Text Key: 64182100
• Report Number: 2029214-2017-00025
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• 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: 03/20/2018
• Device Model Number: PED-400-12
• Device Lot Number: A077203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; 01/11/2017
• Supplement Dates FDA Received: 01/13/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2015
• 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: 72 YR
• Patient Weight: 77