• 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-450-18
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
Corrected information: sex. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex pushwire was returned for evaluation. The pipeline flex braid was not returned as it was implanted in the patient. As received, the pipeline flex pushwire was found outside of the catheter. The tip coil appeared to be stretched. The distal hypotube appeared to be stretched. The middle and proximal section of the ptfe shrink tubing was found to be stretched as well as stripped/peeled off the hypotube. Kinks and bends were found on the pushwire approximately 16. 5 to 53. 5 from the proximal end. Based on the analysis findings and event description, the report of pipeline flex pushwire coating damage was confirmed. The ptfe shrink tubing was found severely stretched and stripped/peeled off the hypotube. It is possible that the patient¿s moderate vessel tortuosity may have contributed to the high resistance during delivery, subsequently causing the pipeline flex pushwire and the catheter to become damaged. Additionally, the damages observed on the catheter body (accordioning), proximal wire (kinking/bending), ptfe shrink tubing jacket (stretching/stripping/peeling off), tip coil and hypotube (stretching) suggest that excessive force used (pushing and pulling). In this event, user context may have contributed to the reported issues as the physician continued to advance the pipeline flex delivery system inside the catheter despite high resistance. Per our instructions for use (ifu), the user should ¿discontinue delivery of the device if high force or excessive friction is encou ntered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ the lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted. All products are 100% inspected for damage and irregularities during manufacture. 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 of pipeline flex pushwire coating damage during a procedure. It was reported that the patient was undergoing flow diversion treatment of a 10mm, fusiform aneurysm in the left, paraclinoid internal carotid artery (ica). The vessel was moderately tortuous. The devices were prepared as indicated in the ifu. It was reported that the pipeline flex was advanced through the catheter with high resistance in the middle section. The physician continued advancement of the pipeline flex and was able to deliver the device to the target location. The pipeline flex was deployed without any noted issues. The pipeline flex pushwire was removed from the patient. Upon removal, the physician noted that the ¿jacket of the pusher was peeled. ¿ there were no reports of patient injury in connection with this event.
 
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 Key6145789
MDR Text Key151431691
Report Number2029214-2016-01090
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/29/2018
Device Model NumberPED-450-18
Device Lot NumberA098405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-