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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-475-35
Device Problems Break (1069); Positioning Failure (1158)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
The pipeline flex braid implanted in the patient. The broken segment of the pushwire remains in the patient and rest of pushwire was discarded. The device will not be returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that pushwire of pipeline flex broke during the procedure. The patient underwent embolization treatment for a medium unruptured saccular internal carotid artery (ica) aneurysm located in cavernous segment. Measuring 18mmx4mm, landing zone distal 4. 9mm proximal 4. 8mm. The vessel was observed moderately tortuous. It was reported that due to a narrowing of the cervical carotid, the physician gave nitro. There may have been a small dissection. It was thought of not doing the case. He proceeded. Initially went in with a 4. 75x25 pipeline and it was nearly all the way deployed, but we had concern that when trying to run the medtronic catheter through it might pop in and drop it into the aneurysm. Thus, we pulled that out and chose a 4. 75 x 35. That was much wagging and receiving and centering, but all in all though pipeline was deploying well as. We were approaching the point of no return marker bands when the catheter curled up like a candy cane. Our fix was to maneuver the medtronic distal access support catheter over the catheter thus straightening out the catheter and deploy the rest of the pipeline in the distal access support catheter. This actually worked well, and the pipeline was now fully deployed with good wall apposition. It was at this point when we try to advance the catheter through the pipeline that we noticed a pipeline wire had separated. The physician took a medtronic revascularization device 6x20 proximal to the deployed pipeline to try to nab the wire from there. Unsuccessful. The physician then tried a 4 x 20 revascularization device to nab from the distal part of the pipeline in the m1. Unsuccessful. Tried a snare retrieval device but unsuccessful. Eventually line for enterprise stance the entire length of the remaining wire to tackle against the vessel wall. Good results. Patient doing fine. There were not any patient symptoms or complications associated with this event. The broken segment left in the patient¿s cavernous ica to m1. The angiographic result post procedure was good.
 
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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 Key10083482
MDR Text Key194754242
Report Number2029214-2020-00480
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 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-35
Device Lot NumberA861603
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 Received05/19/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/10/2019
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: 05/22/2020 Patient Sequence Number: 1
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