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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-35
Device Problems Break (1069); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. Since the device was not returned, we are unable to perform further root cause analysis. Follow up attempts have been made. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that during the pipeline case, the pushwire was alleged to have kinked and broke when it was advanced. The tip coil was also reported to have broken while removing the device. The pushwire/capture coil got stuck during the retraction. The devices were all reported to have been used per the instructions for use (ifu). The aneurysm was in the internal carotid artery (ica), it was ruptured, and amorphous. The max diameter was 4 mm and the neck was 2mm. The landing zone was 2. 7mm distally and 4. 5 mm proximally. The anatomy was severely tortuous. There was no patient injury.
 
Manufacturer Narrative
The device was returned for evaluation and the clinical observation was confirmed. As received, the pipeline flex delivery system stuck within the distal segment of the microcatheter. The pipeline flex was then pushed out from the catheter lumen with difficulty. The distal hypotube was found to be stretched with the ptfe shrink tubing still intact. The pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld. Kinks and bends were found on the pushwire at multiple locations from the proximal end. Additionally, the distal and proximal ends of the pipeline flex braid were found fully opened with moderately frayed. No other anomalies were observed. The surfaces of the detached pushwire were then sent out for sem and eds analyses. Based on the analysis findings and the sem/eds analyses, the distal wire of the pipeline flex delivery system was possibly detached due to tensile failure. In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted. All products are 100% inspected for damage and irregularities during manufacture. The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection. Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against resistance 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. 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.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7565856
MDR Text Key110048720
Report Number2029214-2018-00477
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-35
Device Lot NumberA414762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
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

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