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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-425-12
Device Problem Activation Failure (3270)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 06/03/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline flex device will not be returned for evaluation as it remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation. Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex has successfully expanded, deploy the remainder of the device. Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked. If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it. Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ if information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a pipeline flex device did not open during a procedure. The patient underwent embolization treatment for a small unruptured saccular para-ophthalmic aneurysm, measuring 5mmx4mm, landing zone distal 3. 85mm, proximal 4. 15mm. The vessel was observed moderately tortuous. It was reported that the physician re-sheathed the pipeline 2 times and repositioned the device three times but still pipeline did not open. Opened flat. Balloon angioplasty was used to open the pipeline. After used balloon angioplasty, it was better wall apposition; however, at the distal end of the stent where the pipeline in a transition from flat opening to open but compacted tightly together. The pipeline did not remove from the patient. The pipeline was not placed in a bend. The patient had right sided weakness/aphasia associated with this event. It was reported that this slight weakness was prior to case; due to possible previous stroke. Post procedure angiographic results shows flow to anterior cerebral artery (aca)/middle cerebral artery (mca) territories. The patient is currently in stable condition. It is unknown about any treatment given to the adverse event.
 
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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
7635263305
MDR Report Key8739233
MDR Text Key149345158
Report Number2029214-2019-00615
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 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-12
Device Lot NumberNOT REPORTED
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 Received06/03/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2019 Patient Sequence Number: 1
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