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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-400-10
Device Problems Positioning Failure (1158); Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  malfunction  
Manufacturer Narrative
Event reported based on analysis results. Analysis of the pipeline flex embolization device (model: ped-400-10 lot: b146152) found that delivery system was returned within the phenom catheter and extending ~42. 8 cm from hub and extending ~1. 0 cm from distal tip. The pipeline flex delivery system was then removed from the phenom-27 catheter. The catheter body was found to be accordioned at ~1. 5 cm from distal tip. No bends or kinks were found with the pipeline flex pushwire. The distal hypotube was found to be intact and the ptfe pulled back. The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact. The dps sleeves were found to be damaged. The tip coil was found to be damaged. The proximal end of braid was found to be collapsed. The distal end of braid was found to be opened and frayed. Based on the analysis findings, the customer report of ¿resistance/stuck during delivery¿ was confirmed as the pipeline embolization device was returned stuck within phenom-27 catheter. The returned pipeline flex braid damages (collapsed/frayed) are indicative of high force used. It is likely the damage occurred when the customer attempted to advance the pipeline flex through the phenom catheter against the reported resistance. Possible contributors for resistance are, patient vessel tortuosity or lack of continuous flush during delivery. Based on the device analysis and reported information, the customer¿s report of ¿failure to resheath¿ could not be confirmed and root cause could not be determined. Possible causes for ¿failure to resheath¿ include patient vessel tortuosity, resistance during delivery, delivery system damage, catheter damage, user does not maintain continuous flush, or user re-sheaths more than 2 times. The phenom 27 catheter was continuously flushed with heparinized saline and no damages were found with the returned devices that would have contributed to the event. Information regarding if the device was resheathed more than 2 times was not provided; therefore, any contributing factors could not be assessed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline became stuck in the distal part of the phenom 27 microcatheter. The patient was undergoing pipeline embolization treatment for an unruptured, amorphous aneurysm located in the right ica. The max d iameter and neck diameter were 2mm. The patient¿s vessel tortuosity was moderate. The landing zone was 3. 4mm distal and 3. 8mm proximal. The access vessel was the right ica, which was 3. 89mm in diameter. Dual antiplatelet treatment had been administered. Patient me dical history included a pipeline in left ica, vasospasm, and preeclampsia. It was reported that the doctor pre-shaped the phenom 27 with a gentle curve using a mandrel and steam per the instructions for use (ifu). During advancement of the pipeline, there was significant friction noted as they were coming through the carotid syphon. The goal was to land near ica-terminus but when the doctor noted that the pipeline wasn¿t going to be optimally positioned after partial deployment, they decided to resheath. As they were coming around the clinoidal segment, it became increasingly difficult to resheath. They tried redeploying, but it was completely stuck. The doctor tried pinning the wire while pushing phenom 27 to resheath but it wanted to intussuscept. A continuous flush had been administered. The physician had released the load/slack in the system, but it did not resolve the issue. It was noted that the distal section of the catheter had kinked and accordioned. There had been no damage to the pushwire. It was stated that the placement/positioning was difficult as there was movement and the device missed the landing zone. Only a single pipeline was being used when the movement occurred. The device did not jump during deployment, and the tip of the catheter had not moved. The pipeline was at least 3mm past the aneurysm neck on each side, and no side branches were covered. The pipeline and catheter were replaced. The patient did not experience any injury or complications. The devices were prepared and flushed according to the ifu. Ancillary devices include a 90cm benchmark guide catheter and a traxcess guidewire.
 
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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 Key11832558
MDR Text Key250913526
Report Number2029214-2021-00584
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 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-10
Device Catalogue NumberPED-400-10
Device Lot NumberB146152
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2021
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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