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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-500-30
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2020
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 middle of the pipeline stent was kinked and could not be deployed after repeated adjustments. Once removed from the patient, it was found the middle section was kinked, and it still could not be opened outside of the body. It was indicated that all devices were prepared/flushed 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 a part of the contrast agent remained. The patient was undergoing surgery for treatment of a saccular, unruptured, left side aneurysm with a max diameter of 12. 1mm and a 2. 3mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Ancillary devices include a cook 6f long sheath, 5f navien microcatheter, marksman microcatheter, synchro-14 guidewire.
 
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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 Key10335105
MDR Text Key200867399
Report Number2029214-2020-00740
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536019782
UDI-Public00847536019782
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 10/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/05/2022
Device Model NumberPED-500-30
Device Catalogue NumberPED-500-30
Device Lot NumberA810952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2019
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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