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

Model Number PED-450-25

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

Based on the article photos, the report of pipeline flex migration after deployment was confirmed.The device was not returned for analysis; therefore the event cause could not be conclusively determined.It is possible that the presence of other indwelling endovascular stents may have interfered with the proper deployment and function of the pipeline flex embolization device leading to the reported issue.Additionally, the patient anatomy condition was not reported; therefore any contributing factors from the pipeline braid and patient anatomy could not be assessed.Per our instructions for use (ifu): ¿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.Pushing delivery wire without retracting the micro catheter at the same time will cause the open end braid to move distally in the vessel.This may cause damage to the braid or vessel.The presence of other indwelling endovascular stents may interfere with proper deployment and function of the pipeline flex embolization device.Placement of multiple pipeline flex embolization devices may increase the risk of ischemic complications.¿ salvage of herniated flow diverters using stent and balloon anchoring techniques: a technical note intervent neurol 2017;6:31¿35 doi: 10.1159/000452284 mdrs related to this article: 2029214-2017-00004 2029214-2017-00005 2029214-2017-00006.

Event Description

Medtronic received report from literature of migration of a pipeline flex construct.The patient presented with complete painless loss of vision in the right eye and also had chronic vision loss in the left eye.Subsequently, the patient was found to have a giant, partially thrombosed superior hypophyseal aneurysm arising from the left internal carotid artery (ica).The nonthrombosed part of the aneurysm measured 18 × 15mm and had a 6-mm neck.Given the patient¿s significant medical comorbidities, which excluded surgical management, it was decided to treat the aneurysm with placement of a pipeline flex (ped), as well as to place a few coils within the aneurysm sac to reduce the chances of post-ped placement aneurysm rupture.The article stated that a microcatheter was advanced across the neck of the aneurysm.A 4.5 × 25 mm pipeline flex device was successfully deployed across the neck of the aneurysm and two coil loops were deployed in the aneurysm.Given the large size of the aneurysm and the ongoing mass effect and vision loss, a second 4.5 × 25 mm ped was then placed within the first.After placement of the second ped, the article states that both peds foreshortened such that the distal end of the construct herniated into the aneurysm.Multiple attempts were then made to advance a microcatheter through the lumen of the previously placed peds to regain access to the ica distal to the aneurysm.The presence of coil loops within the aneurysm sac prevented looping of the microcatheter and further distal advancement.A balloon microcatheter was advanced through the lumen of the previously placed ped devices, and after looping within the aneurysm sac (around the coil mass), the physicians were able to access the distal ica.The balloon microcatheter was then advanced into the m1 segment of the mca, where it was inflated and gentle traction was applied to straighten the loop within the aneurysm sac and reposition the distal end of the ped construct in a more favorable configuration.Subsequently another manufacturer¿s stent was advanced through the balloon microcatheter and deployed such that proximally, it telescoped within the ped construct and distally, it was within the m1 segment of the mca.This deployment ensured that the ped construct no longer herniated into the aneurysm sac.A few more detachable coils were then placed within the aneurysm sac to significantly reduce the flow within the aneurysm.At 2 months of follow-up, there was a significant improvement in the patient¿s vision in the right eye.

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: 6220162
• MDR Text Key: 63798752
• Report Number: 2029214-2017-00005
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-450-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR