• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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
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): ¿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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6220160
MDR Text Key106848696
Report Number2029214-2017-00004
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-400-25
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
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
-
-