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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 PED2-300-16
Device Problems Break (1069); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
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 pipeline moved during deployment and the pushwire broke while resheathing. The patient was undergoing treatment for an unruptured, saccular choroidal aneurysm. The max diameter and neck diameter were 2mm. The patient's vessel tortuosity was moderate. The landing zone was 2mm distal and 3mm proximal. The access vessel was the femoral artery, which was 6mm in diameter.  dual antiplatelet treatment was administered, and the pru level was 120. It was reported that the microcatheter was advanced to the distal portion of the middle cerebral artery m1. The pipeline was advanced and positioned in the middle cerebral artery, and release began from m1. When the third part of the device had been released and was in the communicating segment, the device underwent a retraction and was positioned below the choroid aneurysm, so the doctor decided to resheath the pipeline to reposition it. When trying to resheath it, the device suffered distal guide detachment without being able to recapture the mesh and was trapped in the phenom microcatheter. It was decided to maneuver by successfully recovering the entire device system with the sofia catheter.  the device was replaced, and the patient did not experience any injury or complications.  control images performed showed normal flow without brain damage.  no additional medical or surgical interventions was needed, and the patient was not hospitalized as a result of the event. Angiographic results post procedure were normal without complications.  the devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a traxcess guidewire, sofia catheter, phenom 027 microcatheter, and 6fr iva inserter.
 
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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 Key11903110
MDR Text Key254028492
Report Number2029214-2021-00637
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P100018.S026
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 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-300-16
Device Catalogue NumberPED2-300-16
Device Lot NumberB154678
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2021
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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