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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-500-20
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2019
Event Type  malfunction  
Manufacturer Narrative
The device involved in the event has not been returned for evaluation; therefore, the event cause could not be determined. Correspondence has been sent for the device and additional information. Once the device has been received and evaluation has been completed, a supplemental report will be submitted. Same event as mdrs: 2029214-2019-01190 2029214-2019-01191, 2029214-2019-01193, 2029214-2019-01194. If information is provided in the future, a supplemental report will be issued.
 
Event Description
2019-12-03 medtronic received information that the first pipeline flex (ped-500-20) would not open on the distal end. They attempted to resheath numerous times to push the flaps back so it was not covering the distal end, but it still would not open. Ultimately, they decided the pipeline was not going to open distally so they removed it from the patient. Then the physician went in with a phenom-27 and successfully deployed a new pipeline (ped-475-25). Upon attempting to recapture the delivery system with the phenom, the pipeline flex dislodged from its distal anchoring and the distal end of the pipeline flex was floating in the aneurysm. The physician re-wired and re-catheterized the outflow of the proximal end overlapping approximately 50% of the length of the pipeline flex (ped-475-25) deployed proximally. During the same procedure, two axium coils were implanted but has issues with detachment using the instant detacher (id). One coil finally detached with the id, while the other coil required use of the manual method (breaking of the hypo-tube, an alternative detachment method presented in the instructions for use). This was attempted 2 ¿ 3 times before the coil detached. Post procedural angiography showed that all vessels appeared intact and the two deployed pipelines and coils all looked technically placed successfully. The patient was brought back in that evening for stroke like symptoms. There was nothing seen on angiography at that time. It was noted that the pipeline was placed on a bend when it failed to open. The patient¿s vasculature was moderate to severe in tortuosity the patient was undergoing pipeline embolization with concomitant coiling treatment of an aneurysm measuring 4. 32mm, 4. 1mm proximal, 3. 1mm+ distal, 9. 77mm neck. It was located in the supraclinoid segment of the left internal carotid artery (ica). Prior to the coil non-detachment, there were no issues encountered and no damages were observed on the pushwire after removal form the patient.
 
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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 Key9412361
MDR Text Key208996563
Report Number2029214-2019-01192
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 12/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-20
Device Lot NumberA843372
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 Received11/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/06/2019
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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