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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 PED2-500-30
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that failed to open at the distal end and then became stuck during retrieval in the phenom-27 microcatheter. The patient was being treated for an unruptured giant saccular aneurysm of the left internal carotid artery (ica) ophthalmic segment. The aneurysm max diameter was 25mm and the neck diameter was 10mm. Vessel tortuosity was severe. Dual antiplatelet treatment (dapt) was administered. It was reported that the physician began deployment of the pipeline device distal to the aneurysm. The distal part of the pipeline did not open completely. More than 50% of the pipeline was deployed when it failed to open. The device was not positioned in a bend. The device was resheathed and deployment attempted more than 2 times. The device continued to fail to open. Without complete wall apposition, the pipeline was slipping from the desired implant location. Finally, the physician decided to withdraw the pipeline. During the final retrieval, significant resistance was felt retrieving the pipeline back into the phenom microcatheter and the device was retrieved partially open with the microcatheter. Both devices were replaced and a smaller pipeline was successfully implanted to complete the procedure. All the devices were prepared as indicated in the instructions for use (ifu). The catheter was flushed per ifu. There were no patient symptoms or complications associated with this event. Post-procedure angiography showed successful implantation of a pipeline 475-30 device.
 
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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 Key11065700
MDR Text Key225564905
Report Number2029214-2020-01362
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGR
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 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-30
Device Catalogue NumberPED2-500-30
Device Lot NumberB088899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/19/2020
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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