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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-475-30
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Event Description
Medtronic received a report that during the procedure, the pipeline could not be pushed out of the marksman microcatheter due to resistance in the distal segment. There was no damage to the pushwire or catheter, and a continuous flush had been used. A replacement marksman was use, and the procedure was completed. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiographic results showed slowed blood flow in aneurysm. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the clinoid segment of the internal carotid artery (ica) with a max diameter of 14 mm and a 9mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 1. Additional information received indicated the pipeline was replaced to successfully complete the procedure.
 
Manufacturer Narrative
The pipeline flex embolization device and marksman catheter were returned for analysis. The pipeline flex pusher distal hypotube was found stretched and broken with the shrink tubing pulled back. The broken distal portion of the pipeline flex pusher was still within the marksman catheter hub. No damages were found with the marksman catheter body or distal tip. The marksman catheter was dissected (cut) to remove the broken distal portion of the pipeline flex pusher. The pipeline flex pusher resheathing pad was found damaged. A reddish residue was present on the broken pipeline flex distal hypotube and resheathing pad. The pipeline flex braid proximal end was found open; however, a red residue was found on the braid proximal end. The distal braid end was found damaged and not open. During the removal from the marksman catheter, the pipeline flex pusher ptfe sleeves and tip coil were damaged. The pipeline flex broken hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis. Per the analysis report, the fracture surface exhibits corrosion damage, and no original fracture features are visible. Based on the device analysis and reported information, the customer¿s ¿lockup/resistance at distal segment of catheter¿ report 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 the device in distal and tortuous anatomies. No damages were found with the returned marksman catheter that would have contributed to the resistance. In this event, it is possible the patient¿s ¿moderate¿ vessel tortuosity contributed to the event; however, the root cause could not be determined. Regarding the pipeline flex¿s pusher separation issue, 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 formal investigation conducted, pusher separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity. From the damages seen with the pipeline flex pusher (stretching), it appears excessive force was used. In addition, it is possible that the patient¿s ¿moderate¿ vessel tortuosity contributed to the pusher separation issue. 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
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 Key12456399
MDR Text Key280598553
Report Number2029214-2021-01156
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 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-30
Device Catalogue NumberPED-475-30
Device Lot NumberB067929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2020
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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