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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 PED2-300-10
Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a pipeline shield had difficulty unsheathing and deploying, resistance, and failure to open. The patient was being treated for a bi-lobed unruptured aneurysm in the m1-m2 location. The max diameter was 3cmx 4 cm. The neck diameter was 2. 3 mm. The distal landing zone was 3. 2 mm and the proximal landing zone was 3. 9 mm. Vessel tortuosity was normal.   extreme difficulty unsheathing and deploying the pipeline. Normal anatomy, prepped per instructions for use (ifu), standard technique used by experienced physician. An abundance of resistance.  stuck (locked up) in catheter or resistance in catheter. The pipeline became stuck in the distal section of the catheter and became stuck during deployment. The physician released to load in the system and the issue did not resolve. The pipeline failed to open distal. The pipeline was not in a bend. Less than 50% of the pipeline had been deployed. The pipeline was resheathed less than or equal to 2 times. The pipeline was removed with the microcatheter and the was movement during placement (difficult placement/positioning). Multiple devices were not being used when movement occurred. Friction during delivery was severe. The pipeline was not implanted at the intended location. The pipeline did not miss the landing zone or jump during deployment. The pipeline was placed at least 3 mm past the aneurysm neck on each side. No side branches were covered by the pipeline. The tip of the catheter was not moved during deployment.  dapt (dual antiplatelet treatment) was administered at pru level 118. Angiographic result post procedure was successful aneurysm occlusion. No symptoms were reported.   ancillary device: bmx96 sheath, phenom27 and phenom17 microcatheter , axium 4x6 and axium 3x6 coils.
 
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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 Key12442755
MDR Text Key271648353
Report Number2029214-2021-01135
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-300-10
Device Catalogue NumberPED2-300-10
Device Lot NumberB204667
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 Received08/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/12/2021
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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