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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-475-20
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline stent which failed to open at the distal end during a procedure and then became stuck in the marksman catheter. The patient was being treated for an unruptured fusiform aneurysm of the left interior carotid artery. Dual antiplatelet treatment (dapt) was administered and pru level was 175. Patient vessel tortuosity was normal. It was reported that the catheter was navigated to the desired location. The physician started to deploy the pipeline but the distal end of the stent failed to open properly. The physician made multiple attempts to get the pipeline to open - resheathing and redeploying, removing tension in the system, but all without success. More than 50% of the stent was deployed when it failed to open. The device was resheathed less than or equal to 2 times. It was not positioned in a bend. While trying to resheath the pipeline, it beame stuck in the distal end of the marksman microcatheter. After this occurrence, the pipeline and marksman were removed together from the patient. Both devices were replaced and the procedure was then able to be completed successfully. All devices had been prepared and the catheter flushed per the instructions for use (ifu). There was no harm or injury to the patient. Post-procedure angiographic results were normal.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key10824098
MDR Text Key217324297
Report Number2029214-2020-01118
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
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 02/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-20
Device Catalogue NumberPED2-475-20
Device Lot NumberA907491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
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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