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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 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 11/04/2020
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 the doctor felt resistance when rising the pipeline system in the marksman microcatheter. When the release started, the stent did not open in the distal portion. Several maneuvers were performed without success. It was noted the proximal portion of the stent was positioned in a bend, the pushwire was rotated several times, less than 50% of the stent had been deployed, re-sheathing was done more than twice, and no additional steps were taken in an attempt to open the pipeline. The stent and microcatheter were removed, and replacement products were used to complete the procedure. 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 angiography showed the second stent used had perfect results. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the internal carotid artery with a max diameter of 4. 6 mm and a 4. 6 mm neck diameter. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key10824372
MDR Text Key216626886
Report Number2029214-2020-01119
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2021
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 NumberA915540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2019
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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