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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 INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-250-14
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the pipeline pushwire broke and the tip coil was left in the patient. Physician deployed pipeline the usual fashion resistance was felt while navigating the pipeline through the microcatheter but this was attributed to the tortuous vessels. While deploying physician determined that the distal end of the pipeline should be more distal (about 3mm of distal pipeline was deployed distal to aneurysm neck- but the physician wanted to have closer to 5mm of coverage). He decided to attempt to re-sheath the pipeline to move it further distal. During re-sheath ++ resistance was felt by physician and there was no re-sheathing movement. Physician decided that it would be best at this point to finish deployment of the device and the 3mm of distal coverage would suffice. Proximal end of the pipeline deployed without issue but when pulling back on the pusher wire the distal end of the wire remained in the vessel. It was then determined that the pusher wire had fractured just below the proximal markers as well as midway through the wire. The proximal end of the wire was pulled out of the microcatheter and the middle section of the pusher wire came out of the microcatheter on its own and the distal segment remained in the pt. The physician attempted to remove the segment of wire with a snare but was unable. The tip coil appeared to be jammed in a distal vessel and would not move. Physician decided to leave wire in situ. No adverse effects were noted post opp. The resistance was severe when the pipeline was delivered and deployed. This event occurred during the treatment of an acom unruptured aneurysm. The max diameter was 5. 11mm. The neck was unable to be determine as the aneurysm was previously coiled. The landing zone was 1. 7mm and the proximal was 2. 2mm. The vessel anatomy was moderate in tortuosity. The devices were prepared and used per the instructions for use (ifu). The broken segment is within the pipeline aca/ a1/ a2.
 
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Brand NamePIPELINE FLEX WITH SHIELD
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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9519813
MDR Text Key184171608
Report Number2029214-2019-01296
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-250-14
Device Lot NumberA838086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/28/2019
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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