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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 PED2-500-35
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
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pipeline flex w/shield technology model #
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ped2-500-35 as the device was received in a condition was contradictory to the complaint description. The pipeline flex device pushwire found broken. This condition was not reported at time of the event. The pipeline flex braid was returned detached from the pushwire. One end of the pipeline flex braid was found damaged (frayed) and not found fully open. The other end of the pipeline flex braid was found open and in good condition. As the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified. The pipeline flex distal hypotube does not appear to be stretched and the ptfe shrink tubing was intact; however, the shrink tubing was found pulled back from the proximal bumper. The proximal bumper, re-sheathing pad and re-sheathing marker were found intact. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. The tip coil outer coils were found stretched and broken with the inner core wire broken. The broken segment was sent to sem (scanning electron micrographic) for analysis. Per sem report, ¿few original fracture features were available to determine the wire failure mechanism. ¿ based on the device evaluation we were unable to determined the cause of the event. The pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity. In this event the cause was determined to be use related (excessive force) as ¿the pushwire was retrieved into the marksman with a strong force¿ related mdr for event: 2029214-2020-00038. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a third pipeline (reported device) was prepared and delivered in the medtronic catheter who had delivered to distal part, but the delivery became very difficult in the middle of the medtronic catheter. Eventually it became so hard, and it was impossible to deliver the device to the distal part of the catheter. Anomaly was felt, and the pipeline was retrieved together with the pushwire. The aneurysm was in the left internal carotid. It was unruptured and saccular. The max diameter was 15mm and the neck was 10mm. The distal landing zone was 3. 06mm and the proximal was 5mm. The vessel anatomy was moderate in tortuosity. The devices were all reported to have been used and prepared per the instructions for use. A continuous flush was used. Evaluation of the returned device found that the pipeline flex shield braid was returned detached from the pushwire.
 
Manufacturer Narrative
A supplemental report is being submitted at this time due to updates made to analysis results. The pipeline flex embolization device (model: ped2-500-35; lot: a912449) was returned for analysis within a shipping box and within a plastic re-sealable pouch. The pipeline flex braid was returned detached from the pusher. One end of the pipeline flex braid was found damaged (frayed) and not found fully open. The other end of the pipeline flex braid was found open and in good condition. As the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified. The pipeline flex distal hypotube does not appear to be stretched and the ptfe shrink tubing was intact; however, the shrink tubing was found pulled back from the proximal bumper. The proximal bumper, re-sheathing pad and re-sheathing marker were found intact. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. The tip coil outer coils were found stretched and broken with the inner core wire broken. Per the sem report, ¿few original fracture features were available to determine the wire failure mechanism. ¿ no other anomalies were observed. There was no indication that the event was related to a potential manufacturing issue. Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ could not be confirmed. The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary. Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies. In addition, resistance can occur due to patient vessel tortuosity, failure to maintain a continuous flush, or pipeline is pulled back/torqued during delivery. The vessel anatomy was moderate in tortuosity and a continuous flush was maintained. Therefore, the cause could not be determined. Regarding the ¿pushwire separation¿ issue, this event is similar to events that had already been investigated, and another investigation is not necessary. Based on the formal investigation conducted, pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity. However, the root cause could not be determined. If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key9868360
MDR Text Key195755345
Report Number2029214-2020-00283
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-35
Device Catalogue NumberPED2-500-35
Device Lot NumberA912449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
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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