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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT Back to Search Results
Model Number PED-450-25
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2020
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 first pipeline reached the target location with the marksman microcatheter. However, during the deployment process, the pipeline failed to open in the distal segment. The surgeon followed the instructions, re-sheathed, and redeployed the stent more than twice, then waited for more than 10 minutes each time. The slack in the system was released as well, but the stent still would not open. More than 50% had been deployed, the stent was not in a bend, and no additional steps were taken to open the device. It was also stated the stent became locked up in the distal segment of the marksman even though a continuous flush was used. There was no damage to the pipeline pushwire. The devices were removed from the patient. A new pipeline, and marksman of the same model/lot# were used, but the second pipeline became stuck at the distal end of the marksman during delivery. The slack was released in the system, but the issue did not resolve. The distal segment of the second marksman became accordioned, and there was no damage to the pipeline pushwire. Replacement products were used again, and the procedure was completed without issue. 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 the blood flow diversion was satisfied. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the cavernous sinus segment with a max diameter of 7. 88 mm and a 5. 18 mm neck diameter. It was noted the patient's vessel tortuosity was moderate.
 
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Brand NamePIPELINE FLEX
Type of DeviceLASER THERAPY PRODUCT
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10564460
MDR Text Key207910323
Report Number2029214-2020-00955
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,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-25
Device Catalogue NumberPED-450-25
Device Lot NumberB013806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
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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