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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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported physician information cannot be provided due to the restriction by the privacy regulation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the devices were prepared and hydrated per the instructions for use (ifu). However, the pipeline experienced resistance in the middle section of the phenom catheter. Once the pipeline was positioned, it was found the distal tip of the pipeline failed to open. It was noted the distal part of the stent was positioned in a bend, less than 50% had been deployed, resheathing was performed more than three times, and no additional steps or devices were used in an attempt to open the stent. There was little impact to the catheter operation, so the phenom and pipeline were removed from the patient together. Replacement products were then used to complete the procedure. There was no injury to the patient as a result of the event. Post-procedure angiography showed slowed blood flow. The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the left internal carotid artery c2-c3 segment with a max diameter of 6-7 mm and a 5 mm neck diameter. It was noted the patient's vessel tortuosity was severe. Dual antiplatelet therapy (dapt) was administered. Ancillary devices include a 8f roadmaster 80cm, chikai14 200.
 
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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 Key10675944
MDR Text Key211468655
Report Number2029214-2020-01027
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2020
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 NumberA912444
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
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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