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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 LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-450-20
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
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 pipeline was twisted and failed to open in the middle during deployment, and then became stuck in the marksman catheter. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the internal carotid artery with a max diameter of 5mm and a 4mm neck diameter. It was noted the patient's vessel tortuosity was normal. It was reported that the pipeline was delivered through the marksman microcatheter to the treatment location. When unsheathed, the pipeline was twisted in the middle. Re-sheathing was attempted, but the physician could not. The physician tried to un-sheath again but could not. As a result, the system was removed from the patient. Outside of the patient, thepipeline was attempted to be transferred into the introducer sheath, but the pipeline became stuck in the marksman hub. A new pipeline and an excelsior xt 27 were used to finish the case. Post-procedure angiographic results were normal. 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. It was reported that the pipeline had been placed in a vessel bend when it failed to open. Ancillary devices include a longsheath, guider softip, marksman, transend.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key10371429
MDR Text Key202946074
Report Number2029214-2020-00774
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeVM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-20
Device Catalogue NumberPED2-450-20
Device Lot NumberB026784
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2020
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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