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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-250-20
Device Problems Positioning Failure (1158); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2019
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex with shield (ped2) embolization device and the catheter were returned. The ped2 delivery system and catheter were decontaminated. Upon visual inspection of the catheter, no damages were found with the hub or distal tip. The ped2 pushwire was found extending from the catheter hub. The catheter body was found to be accordioned at a couple location. No damages were found with the distal tip. The catheter was measured and found to be within specification. The catheter was dissected, and the ped2 delivery system was removed. The catheter could not be used for testing with an in-house guidewire due to its damaged condition. The ped2 pushwire was found to be bent at the proximal end. The ped2 device was found separated into two segments. The distal hypotube was found to be stretched and ptfe shrink tubing was found to be intact. The pusher was found detached at the distal hypotube weld (solder joint). The proximal bumper and re-sheathing marker were found intact. The re-sheathing pad was found to be missing. Distal and proximal ends of braid were found to be collapsed. The dps restraints/sleeves appear to be in good condition. The tip coil was found intact. The detached pushwire was sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) elemental analysis. The elemental analysis of the detached pushwire end shows elevated chlorine (cl), iron (fe), silver (ag), tin (sn), chromium (cr), and oxygen (o) peaks were detected on the wire surface, and it is not possible to determine the failure mechanism of the subject wire. No other anomalies were observed. Based on the device analysis and reported information, the report of ¿pipeline damaged during delivery/retrieval¿ was confirmed as the ped2 device was found to be separated at distal hypotube. However, the root cause could not be determined. Regarding the solder joint separation issue, as the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted. A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process. Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures. The proof load of 2. 5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that severe friction and difficulty occurred during advancement and placement of the pipeline flex with shield (ped2). The ped2 was not placed in the intended location as it missed the landing zone. Resistance was felt within the distal section of the marksman which caused damage to the ped2. This event occurred during the treatment of an aneurysm located in the communicating anterior area. The aneurysm was unruptured, saccular, with a max diameter of 12 and a neck width or 8mm. The distal landing zone was 1. 9mm and the proximal was 2. 1mm. The vessel anatomy was moderate in tortuosity. No patient injury occurred. The devices were prepared and used per the instructions for use (ifu). The catheter was flushed as per the ifu.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key10067914
MDR Text Key207351095
Report Number2029214-2020-00465
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/02/2021
Device Model NumberPED2-250-20
Device Lot NumberA575709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2018
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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