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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 PED2-450-12
Device Problem Positioning Problem (3009)
Patient Problems Hemorrhage, Cerebral (1889); Dysphasia (2195)
Event Date 06/19/2020
Event Type  malfunction  
Manufacturer Narrative
See manufacturer report # 2029214-2020-00589 for the second pipeline embolization device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline flex with shield technology moved during deployment and a second pipeline did not open distally despite several attempts to open by resheathing. It was reported that the distal internal carotid artery (ica) appeared dysplastic, including the aneurysm neck and the origin of the anterior choroidal. The microcatheter was tracked to m1 and the distal part of the stent opened successfully following a single resheath. The stent was dragged back carefully into the ica terminus at the desired landing location. Tension was building in the catheter as more stent was pushed out. The physician proceeded to gently relieve the tension, and the entire system jumped back proximally. Too much of the stent had been deployed to recapture. The pipeline was not implanted at the intended location. The microcatheter was tracked across the stent which appeared to be fully opposed. The physician decided to place a second pipeline distal as the aneurysm was not covered. After approximately ¼ of the second pipeline was deployed it did not flare distally so the physician attempted to open it by resheathing it 3-4 times. At this point, the pipeline looked abnormal, so a decision was made to remove the entire stent with the microcatheter and replace with new one. A third pipeline was placed successfully. Post procedural angiography showed good stasis in both aneurysms. No patient injury was reported as a result of the event. The devices were prepared according to the instructions for use (ifu). The patient was undergoing embolization of a saccular aneurysm measuring 3. 5mm x 3. 2mm located in the pcom origin of the left ica. The physician was unsure of the status (if patient had bleed) of the aneurysm. The distal and proximal landing zone was 4. 2mm x 4. 3mm. The patient¿s vasculature was moderate in tortuosity. The patient was on dual antiplatelet therapy. There are no images for review. The pipeline flex with shield technology was not placed on a bend and no additional steps were taken to attempt to open it. Ancillary devices: phenom 027 microcatheter, neuron max sheath, navien 072 guide catheter. Additional information received reported that patient experienced a small stroke with dysarthria. The patient was expected to recover with rehab. The likely cause of the stroke was due to the length of the procedure and was said to not likely be embolic as the patient was given prasugrel. There was no mention of unexpected resistance in the procedure. It was also reported that the microcatheter was initially discarded, but the manufacturer representative was able to recover it post procedure. There was a visible kink in the distal part of the microcatheter, and it was unknown if this occurred during the procedure or if it was damaged after it was discarded.
 
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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 Key10203567
MDR Text Key199727461
Report Number2029214-2020-00603
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-12
Device Catalogue NumberPED2-450-12
Device Lot NumberA874049
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/31/2019
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: 06/26/2020 Patient Sequence Number: 1
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