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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-375-20
Device Problems Positioning Failure (1158); Activation, Positioning or SeparationProblem (2906); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2021
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 after 10-15mm the pipeline opened slowly but did not open well, so the physician retrieved the stent and tried to open the wings with the tip of the marksman. It was initially difficult to retrieve but then was gently swayed and re-opened again, during which displacement occurred. The stent and tip of the catheter moved to before the bifurcation of the middle cerebral artery, and still did not open well. Balloon angioplasty was then attempted, but the stent slid into the internal carotid artery, so the stent was retrieved into the marksman. However, the stent became stuck at the micorcatheter tip open retrieval and could not be separated. As a result the pipeline and marksman were replaced to complete the procedure. The distal portion of the microcatheter was found to have kink damage. The patient was undergoing treatment of an unruptured, amorphous right opthalmic artery segment aneurysm with a max diameter of 7mm and a neck width of 3. 6mm. It was noted that the patient's vessel tortuosity was moderate. A continuous flush was used and the devices were prepared per the ifu. There were no related patient symptoms. Post procedure angiographic results showed an unobstructed tumor-bearing artery, a positive outcome.
 
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Brand NamePIPELINE FLEX
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 Key11913562
MDR Text Key253533150
Report Number2029214-2021-00640
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
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 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-375-20
Device Catalogue NumberPED-375-20
Device Lot NumberB163247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2021
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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