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

Model Number PED-400-25

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): ¿after the entire pipeline flex device is deployed, advance the micro catheter through the device making sure not to dislodge the braid.When the micro catheter is distal to the pipeline flex embolization device, retract the delivery wire into the micro catheter tip.If the catheter cannot be advanced through the pipeline flex embolization device, carefully remove the delivery wire through the pipeline flex embolization device construct.¿ 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 pipeline flex migration after placement.The patient had presented with acute onset of painful diplopia.The patient was found to have a wide-neck aneurysm in the cavernous, left internal carotid artery (ica).The aneurysm measured 18x14mm.It was decided that a flow diverter would be placed to treat the aneurysm.The article stated that a pipeline flex (ped) was advanced through the microcatheter and deployed across the neck of the aneurysm in the usual push and pull fashion.When the microcatheter was then advanced over the delivery wire of the ped in order to recapture the flaps at the end of the delivery wire, the ped unexpectedly foreshortened, and its distal end herniated into the aneurysm.The ped was positioned such that it was looped within the aneurysm and the distal end faced the proximal ica.The microcatheter was then advanced through the lumen of the herniated ped, looped inside the aneurysm, and eventually advanced into the distal ica and proximal middle cerebral artery (mca).A new 4.5 × 20 mm ped was then pushed out of the microcatheter into the proximal mca so that the distal end of the device could firmly lean against the inner wall of the mca.Gentle traction was then applied on the catheter, taking care not to push out more of the device.This resulted in a reduction of the intra-aneurysmal loop of the microcatheter, and the distal end of the previously deployed ped was repositioned into a more favorable position.Subsequently, the second ped was gently pulled back from the mca and deployed within the previous ped in a telescoping fashion.The delivery wire of the second ped was then retrieved in a safe manner.Post-ped placement digital subtraction angiography showed stasis of contrast within the aneurysm.At 6 months of follow-up, the patient¿s visual symptoms had entirely resolved, and the ica was widely patent with no residual aneurysm filling.

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: 6220160
• MDR Text Key: 63798765
• Report Number: 2029214-2017-00004
• 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-400-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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