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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 PED2-500-20
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2021
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 two pipeline devices experienced resistance in the distal shaft of two phenom 27 microcatheters and did not open distally. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica. The max diameter was 12mm, and the neck diameter was 6mm. The patient's vessel tortuosity was moderate. The landing zone was 2. 3mm distal and 3. 9mm proximal. The access vessel was the ica, which was approximately 2-5mm in diameter. It was also noted that the pipeline was used off-label to treat an ic ophthalmic 12mm fusiform aneurysm. It was reported that there was strong resistance inside phenom catheter when inserting the central part of the pipeline, making it difficult to deliver. Also, although it reached the mca, the tip expansion was failure. There was stronger resistance when removing the sleeve. It was felt that there was risk of fracture of pushwire of the pipeline so it was removed. This happened to two pipeline and phenomdevices in a row. Eventually, a pipeline of a reduced size was used and it was placed by overlapping. There had been no damage to the catheter or delivery pushwires. The devices were not located in a bend, and less than 50% of the pipeline had been deployed due to the poor distal deployment. The pipeline had been resheathed 2 times or less, and no additional steps were taken to deploy the device.  the catheter was flushed with heparinized saline during the procedure.  post operative blood flow angiography showed no change.  the patient did not experience any injury. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a navien 5 fr guide catheter and chikai black soft tip guidewire.
 
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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 Key11668968
MDR Text Key245513748
Report Number2029214-2021-00432
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
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-20
Device Catalogue NumberPED2-500-20
Device Lot NumberA978559
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 Received04/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2020
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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