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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT Back to Search Results
Model Number PED-500-25
Device Problems Unintended Movement (3026); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that one pipeline failed to open, and both pipelines had difficult placement due to system tension resulting in device replacement. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left posterior communicating (pcom) artery with a max diameter of 14mm and a 9. 4mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered and the pru level was normal. It was reported that the surgeon successfully delivered the phenom 27 microcatheter (pli-30) to the middle cerebral artery m2. The pipeline (pli-10) was delivered in place, and deployed 8mm, but the stent tip did not open. The surgeon tried multiple times, but the tip still did not open. The phenom 27 and pipeline were pulled to the thicker side of the internal carotid artery, and another attempt was made to open the device. System tension caused the distal part of the entire system to fall into the aneurysm, and it could not be put in place for deployment again. The surgeon retrieved the stent and withdrew the stent and microcatheter. A new phenom27 (pli-40) and pipeline (pli-20) were then placed in the middle cerebral artery (mca). The tip of the pipeline opened smoothly, and the surgeon decided to drag the stent to the predetermined distal landing position. The system tension caused the distal part of the entire system to fall into the aneurysm again. Again, the microcatheter and pipeline were removed from the patient. A marksman microcatheter and a third pipeline were then used, and the deployment was smooth. Adherence was good, and post-procedure angiographic results showed good results and blood retention. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. It was also reported that in the two systems, the surgeon tried to push out the stent in vitro, and it was found the guidewire was pushed out but the implantation was not pushed out at the distal end. It was stated it was possible the guidewire was broken and the implantation was stuck in the phenom27. However, this was not confirmed, and conflicts the previously reported information. Ancillary devices include a navien catheter.
 
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Brand NamePIPELINE FLEX
Type of DeviceLASER THERAPY PRODUCT
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 Key10458051
MDR Text Key204928556
Report Number2029214-2020-00852
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 12/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-25
Device Catalogue NumberPED-500-25
Device Lot NumberB027931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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