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

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX 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
 

MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-35
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems Infarction, Cerebral (1771); Death (1802); Hemorrhage/Bleeding (1888); Paraplegia (2448); Device Embedded In Tissue or Plaque (3165)
Event Date 07/31/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline failed to open, the pushwire broke at the hypotube, and the patient experienced complications. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right anterior chroidal with a max diameter of 30mm and a 5mm neck diameter. It was noted the vessel tortuosity was normal. It was reported the device was placed well distally, as the doctor was deploying around the bend of the mca origin/ica terminus, the device began to ribbon or flatten and there was friction. The distal and middle segments of the device failed to open and were positioned in the bend. The physician tried a few techniques to open the device: waited 60 seconds, reduced load, wagging, and resheath just over the point of the device that was flattened. Nothing resolved the issue, so the physician continued deploying and pushed more wire. When trying to reduce the load again by pulling back the device and microcatheter together, it was realized the pushwire was no longer attached. The pushwire had broken at the hypotube proximal to the wire weld. The microcatheter was unsheathed past the resheathing marker, and the device was not open proximally. A microsnare was used in an attempt to grab the wire, but the physician could not grab the proximal end. Eventually, the device was able to be fully opened with the snare. The microcatheter was advanced through the pipeline and the physician was able to grab and pull the wire into the catheter. Once inside, it became difficult to pull the wire and the device was being tugged. Multiple other microsnares and a solitaire were used to grab the wire both distally and proximally, but all attempts were unsuccessful. The broken segment was left in the patient's brain, and the remaining pushwire was discarded. After doing a final run, it was observed the device itself was positioned well with full wallapposition, and there was stasis in the aneurysm, but the mca was slow to fill. The patient was placed on a therapeutic heparin drip. The following morning the doctor reported the patient bled. The stent was open, and stated the patient would have died if it wasn't already mostly thrombosed. The physician said they thought the patient would live, but so far had been plegic on the left. Post-procedure angio-graphic results showed stasis, but slow to fill mca. Ancillary devices include a 8f neuron max, 90cm, navien. 058, 115cm, phenom 27, 150cm, chikai black 14.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10367676
MDR Text Key201839950
Report Number2029214-2020-00770
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-35
Device Catalogue NumberPED-450-35
Device Lot NumberA887311
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 Received09/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/23/2019
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: 08/05/2020 Patient Sequence Number: 1
-
-