• 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-300-18
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2018
Event Type  Injury  
Manufacturer Narrative
Cerejo, r., bain, m., masaryk, t.(2017).Balloon sandwich technique for retrieval of fractured delivery wire of pipeline stent.Interventional neuroradiology, 24(1), 40-42.Doi:10.1177/1591019917732287 the pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found a report of pipeline delivery wire fracture during a procedure.The patient presented with bilateral ophthalmic aneurysms -- the left aneurysm measured 7 mm and right aneurysm measured 4 mm.The left aneurysm was successful treated with a pipeline flex; the physicians then proceeded to treat the right aneurysm also with a pipeline flex.During the procedure, the pipeline flex was deployed.Resheathing was attempted by advancing the microcatheter over the delivery wire.The article states that the proximal markers were successfully recaptured, but the "entire length of the core wire under the device" fractured as the microcatheter neared the distal marker.When it was realized that the wire had fractured inside the microcatheter, retrieval was attempted by manipulating the intermediate catheter and microcatheter.These attempts were unsuccessful and the microcatheter was removed.A gooseneck snare device through the intermediate catheter was attempted, but was also unsuccessful.Afterward, a balloon microcatheter was navigated to the distal end of the intermediate catheter.The balloon was inflated sandwiching the fractured wire between the balloon and intermediate catheter.The entire system was pulled out successfully.The pipeline braid was well apposed to the vessel wall, but during manipulation, the braid migrated down and did not adequately cover the aneurysm neck.A second pipeline flex was placed overlapping the first.There was reportedly good stagnation in the aneurysm.The patient had a normal neurological exam post-procedure.Angiographic follow-up at six months demonstrated complete occlusion of the aneurysm.
 
Manufacturer Narrative
Event information - additional information.Expiration date, lot number - additional information.Date manufacturer received - additional information.Type of report - additional information.Follow-up type - additional information.Device manufacture date - additional information.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient's weight was not provided, but was described to be "normal" for their height.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7447323
MDR Text Key106062916
Report Number2029214-2018-00308
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 Physician
Type of Report Initial,Followup
Report Date 07/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/21/2018
Device Model NumberPED-300-18
Device Lot NumberA094583
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/26/2018
Initial Date FDA Received04/20/2018
Supplement Dates Manufacturer Received06/25/2018
Supplement Dates FDA Received07/22/2018
Date Device Manufactured04/22/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
-
-