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

MAUDE Adverse Event Report: MEDTRONIC 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
 

MEDTRONIC PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-20
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2016
Event Type  malfunction  
Manufacturer Narrative
The device was not returned as is remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation. However, based on the reported information, operator's technique contributed to the dislodged braid event. Per pipeline flex instruction for use: after the entire pipeline¿ flex embolization device is deployed, advance the micro catheter through the device making sure not to dislodge the braid. Information received from the same report as mdr mfr: 2029214-2016-00127.
 
Event Description
Medtronic received information that a pipeline flex was delivered and "jumped" down upon removing the microcatheter and a second pipeline flex did not open during treatment of an aneurysm located in the superior hypophyseal segment of the right internal carotid artery (ica). The aneurysm located just before the bifurcation of the middle cerebral artery (mca) and anterior cerebral artery (aca). The patient had moderate vessel tortuosity and received dual antiplatele treatment prior to procedure. It was reported that the landing vessel was tapered with distal diameter of 3. 5mm and the proximal diameter 5. 0 mm. The aneurysm max diameter was 10 mm and the neck width was 8 mm. The physician chose the device according to the large part of the proximal vessel. Physician planned to implant a ped-500-20, which was successfully implanted. The physician advanced the microcatheter through the device and captured the delivery wire with the microcatheter and removed it. However, when he removed the mirocatheter the device jumped down to the neck of the aneurysm. The physician then decided to implant another device ped-475-16 to the distal vessel to be able to cover the distal aneurysm neck. The physician passed the first device placed and attempted to deploy the second device however was unable to open the device as the middle distal part of the device did not open. The first landing zone was straight but the mid segment was a curve. The physician opened the device in a straight vessel and then continued to open during a curve. The device was deployed near to resheathing marker but the device stayed like a "sandwich. " the physician tried to resheath and re-deploy several times but the device did not open. The device was resheathed within the marksman and removed together from the patient. The physician passed the first device again using another device ped-400-16 and was successfully implanted to the distal part and finish the case successfully. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key5469856
MDR Text Key39426284
Report Number2029214-2016-00128
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
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
Report Date 02/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/25/2017
Device Model NumberPED-500-20
Device Lot Number9967350
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 Received02/03/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/25/2014
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: 03/01/2016 Patient Sequence Number: 1
-
-