MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-425-20

Device Problems Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

The push wire is expected to be returned to our lab for analysis.Analysis of the device is anticipated and the results will be sent upon completion of the investigation.

Event Description

Medtronic received information that during treatment of an aneurysm located in the ophthalmic segment of the right internal carotid artery the pipeline did not open properly.Information was also received indicating that the push wire was observed detached at the hypotube, proximal to wire weld.The broken segment of the push wire remains in the patient located within the middle cerebral artery.It was reported that the physician started to deploy the device in the middle cerebral artery (mca) by pushing the delivery wire, and when it was distally opened she moved the device below the bifurcation of the pcom artery covering the aneurysm.The device was first deployed in a straight segment, as it approached a curve, the pipeline became difficult to open.The device was resheathed several times in effort to open the device, but it was impossible as severe friction was encountered.Angiograph confirmed that the pipeline poorly opened.It was then believed the proximal bumper ruptured, because the pipeline device didn't respond to the maneuvers.The pipeline device opened proximally, but not enough to pass through a balloon.The balloon was then used in an attempt to open the pipeline device; however the pipeline would not successfully open, as the proximal part was not well placed on the artery.The pipeline was implanted and remains in the patient.

Manufacturer Narrative

The pipeline delivery system was returned for analysis.As received, the proximal segment of the pipeline flex pushwire was observed stuck within the distal segment of the microcatheter.It was confirmed that the pushwire was detached at the hypotube proximal to the wire weld.The pipeline braid and the detached distal segment of the pushwire were not returned as they remain in the patient.For further investigation, the catheter was then dissected to remove the proximal segment of the pushwire.The catheter had accordion damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.In addition kinks and bends were found on the pushwire.The detached distal end of the hypotube was then sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) analyses.Based on the reported event details, the analysis findings and the sem/eds analyses, the clinical observation was confirmed.We are unable to definitively determine the cause of the reported experience.The elemental analysis conducted through sem)/eds showed presence of soldering material (tin); thereby indicating that the soldering was conducted.In addition, a review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.However, the damages observed on the pushwire proximal wire, pipeline braid, hypotube and catheter body suggest excessive force such as pushing and pulling.It is possible that the moderate vessel tortuosity may have contributed to the gradual resistance; subsequently causing the devices to become damaged and detached.However, the cause for the resistance could not be determined.In this event, the user may have contributed to the reported issues as the physician continued to advance the pipeline flex delivery system despite the resistance.Furthermore it is possible that the patient anatomy (deploying on curve) may have contributed to the issue.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.The system is designed to allow for 2 full cycles of resheathing of the pipeline flex embolization device.Resheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.In addition, the ifu indicates: do not use the pipeline flex embolization device in vessel diameters that are larger than the labeled diameter.Select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration.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
• 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: 5998924
• MDR Text Key: 56444320
• Report Number: 2029214-2016-00867
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2018
• Device Model Number: PED-425-20
• Device Catalogue Number: PED-425-20
• Device Lot Number: A161315
• 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: 09/09/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided; 10/20/2016
• Supplement Dates FDA Received: 11/16/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 60