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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 Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems Fistula (1862); Intracranial Hemorrhage (1891)
Event Date 05/27/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the distal segment of the pipeline failed to open. The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the left internal carotid-cavernous artery. The max diameter was 23mm, and the neck diameter was 13mm. The patient's vessel tortuosity was severe. The landing zone was 5mm distal and 3. 5mm proximal. The access vessel was about 4-5mm in diameter. Dual antiplatelet treatment was administered. It was reported that the pipeline was planned to be implanted in the vicinity of the internal carotid-ophthalmic segment. The distal tip of the pipeline deployed poorly. An attempt was made to resolve the poor deployment by performing resheathing with the phenom 27 microcatheter several times, changing the deployment position, and delivering guide catheter slightly distally. Since it could not be resolved, it was decided to replace the device and the pipeline was collected with the microcatheter. The distal part of the pipeline was located in a bend when it failed to open, and less than 50% had been deployed at the time. The device had been resheathed 3 or more times, and no additional devices or other steps were taken to deploy the device. The pipeline had experienced resistance in the distal part of the phenom 27 shaft. The pipeline and phenom catheter were removed. After that, when confirmatory contrast was performed, a phenom17 was induced transarterically because a carotid-cavernous fistula (ccf) came to the distal side of the aneury sm. Coil embolization was performed from the venous side, but bleeding did not stop so high flow bypass was performed. It was changed to a surgical procedure. Since the patient was under general anesthesia, the patient's consciousness could not be confirmed, but t here was no regurgitation into the skull by ct imaging and there seemed to be no changes in vital signs. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a phenom 27 microcatheter, navien 5f guide catheter, and chikai 14 guidewire.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11940127
MDR Text Key254639097
Report Number2029214-2021-00671
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-35
Device Catalogue NumberPED2-500-35
Device Lot NumberB188100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/04/2021 Patient Sequence Number: 1
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