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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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
If information is provided in the future, a supplemental report will be issued.
 
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. 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 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 non-thrombosed part of the aneurysm measured 18 × 15 mm 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.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL 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 Key6220167
MDR Text Key106847590
Report Number2029214-2017-00006
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
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 Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/03/2017 Patient Sequence Number: 1
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