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

Model Number FA-77325-20

Device Problems Break (1069); Positioning Failure (1158); Kinked (1339); Stretched (1601)

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

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that during treatment of an aneurysm located in the ophthalmic segment of the internal carotid artery (ica), the distal segment of the device would not open and the distal segment of the push wire was fractured.It was reported the distal end of the pipeline device did not open, despite making adjustments and rotating the push wire.It was further reported that resistance was encountered within the microcatheter during delivery and the push wire was not rotated more than 10 times.The pipeline device was removed by withdrawing into the guidecatheter.It was then noted that the distal segment of the push wire was fractured.The physician removed the fractured push wire segment successfully using a mechanical thrombectomy device.No broken fragments remained inside the patient; the surgery was prolonged about an hour.A new pipeline was used and released successfully.No patient injury was reported.

Manufacturer Narrative

Updated: device codes.The flow diverter¿s pushwire and the mechanical thrombectomy were returned for evaluation.The flow diverter¿s braid and microcatheter were not returned.The flow diverter¿s capture coil was observed to be stretched and bent with the flow diverter¿s pushwire being within.No breaks or separations were found on the pipeline pushwire.No device fractured parts were found within the mechanical thrombectomy stent device.No damages were found on the tip coil, proximal bumper, or the mechanical thrombectomy device.Coating damage was observed on the distal and the proximal segments of the pushwire.No other anomalies were observed.However, the cause for the damage on the capture coil could not be determined.Based on the analysis findings and the reported event details, the report of stuck in stuck inside capture coil and pushwire break/separation issues was not confirmed.The cause for the reported experience could not be determined as the flow diverter¿s braid was not attached to the capture coil and the pushwire was found to have no breaks or separations.The damages found on the capture coil and the flow diverter¿s pushwire may have contributed to the reported device tuck inside capture coil issue.The coating damage on the proximal end of the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu): select an appropriately sized flow diverter such that its fully expanded diameter is equivalent to that of the largest target vessel diameter.An incorrectly sized flow diverter may result in inadequate device placement, incomplete opening, or distal migration.If high force or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance.Remove device and microcatheter simultaneously.Advancement of the flow diverter against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal 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.Detachment can be facilitated by slowly rotating the delivery wire in the clockwise direction and/or manipulating the microcatheter by locking down the delivery wire and moving both as a system.If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered flow diverter, rotate the wire clockwise while advancing the wire to try to release it, then slowly pull back on the delivery wire.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• 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 ; 9492753836
• MDR Report Key: 5985754
• MDR Text Key: 55871171
• Report Number: 2029214-2016-00841
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2018
• Device Model Number: FA-77325-20
• Device Catalogue Number: FA-77325-20
• Device Lot Number: A049104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• 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: 39 YR