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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED3-027-450-16
Device Problem Activation Failure (3270)
Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994)
Event Date 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
See related regulatory report 2029214-2020-00558. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding two pipeline devices used in a procedure with mid-section apposition issues. It was reported that after the first pipeline vantage device could not be successfully implanted, it was removed and was replaced with another pipeline vantage (4. 5 x 16). This device was delivered just distal to the aneurysm. The device opened well at the distal end and was well anchored. However, during the second turn this device also flattened. The surgeon was able to address the flattening. The device opened up and and was well-apposed. Ct angio confirmed the device was open and in the correct location. The surgeon was happy with the deployment and outcome. After the procedure, the patient complained of pain and numbness in their right lower leg which was successfully treated with pain medication. The patient was discharged according to plan without additional medical intervention and no extension of hospitalization. Additional information was received from the health care provide and reported by the manufacturer representative who was present during the procedure reporting that the proximal end of the pipeline vantage device was positioned in a bend. The distal end was in a straight segment and opened well. The surgeon attempted 2-3 times to resheath the pipeline though never completely resheathed and it failed to open. After the first pipeline was replaced and the second device had similar issues and resheathing was also not successful but the surgeon was able to open the device by crossing the microcatheter back through it. Though not confirmed, it was suspected that the patient's vessel tortuosity was the most likely cause of the issue with the pipeline vantage device(s) not opening well. There were no images available for review.
 
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Brand NamePIPELINE VANTAGE WITH 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 Key10324460
MDR Text Key200872736
Report Number2029214-2020-00730
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,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-450-16
Device Catalogue NumberPED3-027-450-16
Device Lot NumberA942463
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 Received08/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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