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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-250-14
Device Problem Unintended Movement (3026)
Patient Problems Headache (1880); Intracranial Hemorrhage (1891)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline moved during placement. The patient was undergoing treatment for a ruptured aneurysm located in the right posterior inferior cerebellar artery (pica). The max diameter was 6mm, and the neck diameter was 4mm. The patient's vessel tortuosity was severe. The landing zone was 2. 25mm distal and 2. 25mm proximal. It was reported that the vertebral artery was dissected proximal to the pica and severely narrowed. The pica aneurysm had ruptured approximately 4 days earlier, and the patient was stable. Balloon angioplasty of the dissected portion of the vertebral artery was performed. A sophia catheter(intermediate) was advanced to the dissected portion of the vertebral artery and then a marksman catheter and synchro soft wire were used to access the pica and cross the aneurysm. The aneurysm had an internal loop that was ultimately straightened out but remained under tension. The wire was removed and the pipeline was advanced. During advancement the pipeline caused the marksman to retract several millimeters. Regardless of the efforts by the physician to re-advance the system the marksman eventually lost access and during the process the aneurysm was re-ruptured. Emergent coiling was performed to embolize the pica and the vertebral artery at the dissection. Ct scan was performed intraoperatively and showed little to no hemorrhage. The patient was recovered out of general anesthesia in the room and neuro checks were performed. The patient reported a headache later in the day but was otherwise fine. The patient did not experience any injury or other complications. There was no friction/difficulty during delivery or positioning, and only a single pipeline was being used when the movement occurred. No additional steps were required to remove/secure the pipeline. The pipeline did not miss the landing zone, did not jump during deployment, no side branches were covered, the tip of the catheter was not under stress, and the tip of the catheter did not move or jump during deployment. The pipeline was not placed at least 3mm past the aneurysm neck on each side.  it was noted that the pipeline was not prepared according to the instructions for use (ifu) in that the ptfe sleeves were deployed on the back table prior to deployment. The physician stated this was their standard method.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12036964
MDR Text Key261696650
Report Number2029214-2021-00757
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,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-250-14
Device Catalogue NumberPED-250-14
Device Lot NumberB083052
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 Received06/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2020
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: 06/21/2021 Patient Sequence Number: 1
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