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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 PED2-250-12
Device Problems Activation, Positioning or SeparationProblem (2906); No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  malfunction  
Manufacturer Narrative
Refer to manufacturer report 2029214-2020-01080 for details pertaining to the related reportable event. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline was placed without complications. However, it was difficult to re-sheath the pushwire, and the ptfe wings did not allow the distal guide to be removed from the pipeline. When removing, the pipeline stent shrunk, and it was necessary to place another pipeline. It was noted the pushwire was rotated three times, and full wall apposition was achieved. 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. Post-procedure angiographic results showed another diversion of greater length was placed due to shortening of the diversion that failed. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right middle cerebral artery (mca) with a max diameter of 3. 1 mm and a 2. 8 mm neck diameter. It was noted the patient's vessel tortuosity was moderate.
 
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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 Key10763061
MDR Text Key214799828
Report Number2029214-2020-01081
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
Report Date 11/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-250-12
Device Catalogue NumberPED2-250-12
Device Lot NumberB033638
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 Received11/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/02/2020
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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