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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 PED2-400-16
Device Problems Break (1069); 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 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the doctor went up with the phenom and avigo microguide, positioned themselves in the anterior cerebral artery and removed the microguide, raised the pipeline device and began to release it in the paraophthalmic segment. The diver opened in its distal portion; however, when it was going through the segment in the middle, the device did not open so the doctor re-sheathed the device and tried to free it again without success. When they tried to recapture the entire device to rearrange it, they only entered the guide wire in the microcatheter, leaving half of the pipeline in the vessel out of it. They tried to retract the microcatheter and push the guide wire to deploy the mesh, but the device's release system was detached. The guide wire was advancing alone without deploying the mesh. They tried to resheath it without success. The doctor decided to raise the navien catheter to rescue the device with half of the pipeline that was left outside the microcatheter, successfully removing the entire system. The event lead to or extended the patient's hospitalization for approximately 10 days. Dapt (dual antiplatelet treatment) was administered, and the patient's pru level was 140. Angiographic result post procedure was normal. The patient was undergoing surgery to treat an unruptured, fusiform aneurysm located at the right ophthalmic carotid artery with a max diameter of 3 mm and a neck diameter of 3 mm. It was noted the vessel tortuosity was minimal. There were no patient symptoms associated with the event. The devices were prepared as indicated in the ifu. There was no friction or difficulty during positioning.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10826816
MDR Text Key217325711
Report Number2029214-2020-01121
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-16
Device Catalogue NumberPED2-400-16
Device Lot NumberB015311
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 Received11/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/11/2020 Patient Sequence Number: 1
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