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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX WITH SHIELD LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-425-16
Device Problems Break (1069); Detachment of Device or Device Component (2907); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2020
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 pipeline failed to open and the pushwire broke. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery with a max diameter of 18mm and a 4. 6mm neck diameter. It was noted the patient's vessel tortuosity was severe. It was reported that due to the vessel tortuosity, the distal end of the pipeline failed to open at the site of the aneurysm. Both the navien and phenom27 were pushed and pulled repeatedly about ten times in an attempt to open the pipeline, but once 1/3 of the pipeline was deployed, the proximal bumper of the pushwire near the wire weld broke suddenly. The pushwire was removed, and the entire delivery system was removed leaving the broken segment of the pushwire and the pipeline in the femoral artery. The broken segments were safely removed via kocher and the procedure was ended. Angio contrast showed there was no change from before the procedure and there was no harm to the patient. Ancillary devices include a medikit super sheath 8fr, roadmaster 8 fr, navien, phenom27, chikai14.
 
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Brand NamePIPELINE FLEX WITH SHIELD
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 Key9896299
MDR Text Key199070400
Report Number2029214-2020-00305
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-425-16
Device Catalogue NumberPED2-425-16
Device Lot NumberA835008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2019
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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