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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-30
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for evaluation. Correspondence has been sent out to inquire on the status of the device return and received notice that the device will be returned, but no tracking number was included. Once the device is received and evaluation is complete, then a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the flow diversion device encountered resistance in the distal segment of the microcatheter as it was released, and the distal segment of the flow diverter device could not be opened despite many attempts and also could not be withdrawn. There were no additional intervention or techniques used to open the flow diverter. Finally, the entire system was removed from the patient¿s body and a device from another manufacture was used to complete the procedure. Prior to the event, the microcatheter was advanced across the neck of the aneurysm and delivered a 4. 5mm x 30mm flow diverter. At the point of release, the reported event occurred. The patient was undergoing flow diversion embolization of an unruptured saccular aneurysm measuring 18mm x 8mm located in the left ophthalmic artery. The distal and proximal landing zone was 4. 4mm by 4. 5mm. The patient¿s vasculature was moderate in tortuosity and the access vessel was the femoral artery with diameter of 4. 5mm. No patient injury was reported as a result of the event.
 
Manufacturer Narrative
The pipeline flex was returned for evaluation with the catheter. As received, the pipeline flex was within the catheter and could not be pushed forward or removed. For further examination, the catheter was cut to remove the pipeline flex delivery system. The pipeline flex distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The distal and proximal ends of the pipeline flex braid were found fully open with moderate fraying on the distal end. The pipeline flex pushwire appeared to be bent approximately 24. 5 cm from the proximal end. Based on the analysis findings and event description, the report pipeline flex failure to open on the distal end could not be confirmed. The distal end of the returned pipeline flex was found fully open with moderate fraying. In addition, the proximal end of the braid appeared to be fully opend with no damage. Possible causes of the reported event include the patient¿s vessel tortuosity and damaged braid. From the damages seen on the catheter body (accordioning), pipeline flex braid (fraying), proximal wire (bending) and hypotube (stretching), it appears there was high force used (pushing and pulling). It is likely these damages occurred when the customer attempted to advance the pipeline flex through the micro catheter against resistance. Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is enco untered during delivery. Identify the cause of the resistance and remove device and micro catheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against res istance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. ¿ no evidence was found to suggest that the devices failed to meet specifications; therefore, manufacturing has been ruled out as a po tential cause. All products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7410106
MDR Text Key105254122
Report Number2029214-2018-00263
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/12/2020
Device Model NumberPED-450-30
Device Lot NumberA569747
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/13/2017
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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