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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 PED2-500-14
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
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 part of the pipeline failed to open and appeared to be damaged. The patient was undergoing treatment for a ruptured, saccular aneurysm located in the ica. The aneurysm had previously undergone coiling. The landing zone was 3. 9mm distal and 4. 45mm proximal. The patient's vessel tortuosity was severe. The patient was not on dual antiplatelet treatment. It was reported that the distal part of the pipeline was placed in a bend when it failed to open, and less than 50% had been deployed at the time. The pipeline had been resheathed two or less times. No additional attempts were made to open the device. The pipeline was removed and replaced.  angiographic results post procedure showed a good final result with the second device.  the patient did not experience any injury or complications. It was noted that the devices were not prepared according to the instructions for use (ifu); the device was manually back flushed very aggressively and tightened down very hard on the device making it hard to push the fluid to hydrate. The manufacturer representative believed may have impacted the device and damaged distal end. Ancillary devices include an infinity sheath, phenom plus guide catheter, and phenom 27 microcatheter.
 
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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 Key12105035
MDR Text Key259718049
Report Number2029214-2021-00804
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S026
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 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-14
Device Catalogue NumberPED2-500-14
Device Lot NumberB179373
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 Received06/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/22/2021
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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