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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-400-16
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description. The pipeline flex appeared to be separated at proximal to the dps sleeves. This condition was not reported at time of the event. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact and fully opened with no signs of damage. Dried blood observed on the sleeves. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The pipeline flex braid were fully opened and no damage. Bends found from the broken end; and from proximal end of the pushwire. No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper. The broken end sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analyses. Based on the analysis findings and sem (scanning electron micrographic) / eds (energy dispersive spectroscopy), the fracture surface exhibits dimple features consistent with torsional overload failure mechanism. From the damages seen on pushwire (bending) and hypotube (stretching); it appears there was high force used. It is likely these damages occurred when the customer attempted to advance the pipeline flex through the catheter against resistance. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that pipeline flex device stuck in the phenom catheter. The patient underwent embolization treatment for an unruptured saccular internal carotid artery (ica) para ophthalmic aneurysm with pipeline treatment. Landing zone distal 3. 20mm proximal 3. 80mm. The vessel was observed moderately tortuous. It was reported that pre images were taken and the pipeline size was chosen. As the pipeline was being seated into the rotating hemostasis valve (rhv) and the pipeline was attempted to advance, immediately the staff felt resistance. The rhv was checked and nothing seemed to be awry. They tried to pull back and the pipeline would not retract. At this point in time, it was felt the device was not safe to continue to put in the body, so requested to have it removed from the patient along with the phenom that it was stuck in. The pipeline never made it out of the phenom catheter into the patient. It never caused harm during the case, it just delayed the procedure. I did notice it appeared something was stuck in the end of the phenom upon removal from the patient, so i have included both the pipeline and the catheter. The physician feels the resistance began as the pipeline entered the hub of the phenom. No patient injury was reported as a result of the event. Evaluation of the returned device found that the pipeline flex appeared to be separated at proximal to the dps sleeves.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9629064
MDR Text Key207384074
Report Number2029214-2020-00072
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-16
Device Lot NumberA834386
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2019
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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