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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-027-450-25
Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
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 product was stuck (locked up) in the catheter and there was resistance in the catheter at the distal end during deployment. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right ica (internal carotid artery), opht almic segment with a max diameter of 16mm and a 12mm neck diameter. It was noted the patient's vessel tortuosity was moderate. It was reported that the procedure planned to leave an echelon inside the aneurysm to practice a jailing technique. During the deployment of the device, everything worked properly but when the physician reached the not resheathing marker, they could not continue. They were unable to resheath without and with pushing the pusher. The unload of the whole system occurred, however, the same problem persisted. It seemed that the proximal part of the resheathing mechanism was stuck in the microcatheter. The inr took the microcatheter fixed with the push and they pulled back both together inside the navien. During this process, there was no problem detected so the pipeline and phenom were removed together. The catheter was flushed continuously with heparanized saline. The physician attempted to release the load (slack) in the system in an attempt to resolve the issue, however, it did not resolve the issue. The catheter was not damaged. The pushwire was damaged, however, at the proximal end. The pushwire was damaged due to force transmitted to try to deliver the ped when it became stuck. A shorter ped was implanted to resolve the issue. A dapt (dual antiplatelet treatment) was administered. The pru level was unknown. The angiographic post procedure result was good. The pipeline was used for an approved on label procedure and prepared as indicated in the ifu. There were no patient symptoms or complications associated with this event. Ancillary devices include a navien guide catheter 6f 115cmsynchro with extra support.
 
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Brand NamePIPELINE VANTAGE WITH 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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12637498
MDR Text Key281990740
Report Number2029214-2021-01279
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-450-25
Device Catalogue NumberPED3-027-450-25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
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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