• 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 DEVIE 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 DEVIE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-16
Device Problem Activation Failure (3270)
Patient Problem Intimal Dissection (1333)
Event Date 01/12/2018
Event Type  malfunction  
Manufacturer Narrative
The reported device was received and evaluated. As received, the pipeline flex embolization device with shield technology (ped2) braid was not attached to its pushwire. Both ends of the ped2 braid appeared opened with no damage. Further examination of the ped2 pushwire found no anomalies. Based on the product analysis, the report of the ped2 failed to open at the distal segment could not be confirmed. The patient's moderate vessel tortuosity could have been a factor that contributed to the reported issue, but actual cause of the clinical experience could not be conclusively determined or explained from product analysis. The ped2 instruct for use states, "precautions ¿ 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. ". All devices are 100% inspected for damage and irregularities during manufacture. No evidence was found to suggest that the devices failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
=
pipeline flex w/shield technology model #
=
ped2-450-16. The device has not been received for evaluation. Therefore, the reported clinical experience cannot be conclusively determined. Further information has been requested. Should the reported device be received for evaluation or additional information is available, a follow up report will be filed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a pipeline flex embolization device with shield technology (ped2) did not open at the distal segment during a flow diversion procedure. The device was used for treatment of a patient's saccular cerebral aneurysm located at the right internal carotid artery. The distal and proximal landing zone artery size were 3mm and 4. 2mm respectively. Vessel tortuosity was described as moderate. It was reported the device was prepared following the instruction for use. The ped2 was used with a non-medtronic microcatheter. After the ped2 was positioned distally to the aneurysm, the physician began to deploy the ped2 in a straight segment of the parent vessel. The distal segment of the ped2 did not open. The ped2 was resheathed followed by a 2nd attempt to deploy the ped2. The distal segment of the ped2 remained not opened. The physician unsheathed more of the ped2 braid to more 50%, but the situation did not changed. The physician then brought the distal access catheter closer to the ped2 and relieved the slack in the system followed by resheathing and unsheathing of the ped2. Three more attempts were made to deployed the ped2. As the distal segment of the ped2 remained not opened, this device was removed from the patient. It was reported the patient had injury to right internal carotid artery, howe ver, the detail condition of the injury was asked but not provided. A second ped2 was used to treat the patient. The post procedure angiograph was reported as good.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX EMBOLIZATION DEVIE
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 Key7239147
MDR Text Key271467621
Report Number2029214-2018-00081
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
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 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/25/2019
Device Model NumberPED-450-16
Device Lot NumberA283980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-