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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 PED2-275-14
Device Problems Break (1069); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
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 pushwire broke after experiencing resistance in the marksman microcatheter, which also had resistance in the navien guide catheter. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right middle cerebral artery. The patient's vessel tortuosity was moderate.  dual antiplatelet treatment was administered. It was reported that the pipeline device was successfully released and implanted, but during the removal of the delivery wire from the system, the doctor observed resistance of the delivery wire in relation to the marksman microcatheter and also of the microcatheter in relation to the navien intracranial access catheter. After that, the doctor opted for the removal of the two systems. At this time it was observed that the distal portion of the delivery wire had fractured and completely detached from the system. The microcatheter and intracranial catheter were irrigated looking for this distal part. This was successful, and after the doctor made sure that they were not found in the operative field, they identified the part mentioned on the floor of the room.  it was noted that when removing the delivery wire, the doctor did not raise the marksman microcatheter inside the stent to cover the delivery wire (tip coil), not following the recommendations.  no extended hospitalization or additional medical/surgical interventions were needed. Angiographic results post procedure showed no problems, and the results were as expected.  the patient did not experience any injury or complications. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a navien 6f guide catheter, marksman microcatheter, and avigo guidewire.
 
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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 Key11838577
MDR Text Key251191859
Report Number2029214-2021-00588
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-275-14
Device Catalogue NumberPED2-275-14
Device Lot NumberA834391
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 Received06/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/20/2019
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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