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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 PED2-400-16
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem Stenosis (2263)
Event Date 10/01/2020
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 there was resistance between the pipeline and phenom during deployment, and the guide separated from the pipeline. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left carotid siphon with a max diameter of 4 mm and a 3. 5 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was a dministered: prasugrel. It was reported that the phenom microcatheter was placed in the m1 segment, and then placed in the desired distal landing zone of a healthy carrier vessel. The deployment of the pipeline met difficulty where the first segment was able to appositioned, but then the delivery force began to increase in the distal segment of the catheter. A closed stenosis appeared, and the recommended maneuvers to stabilize the deployment and releasing the slack were performed but not successful. At that moment, the guide was separated from the pipeline device, and an entrapment of the prosthesis was generated within the microcatheter with impossibility of moving it. The operator said this was a rare situation as it had not happened before, and then the entire system was removed. It was found the catheter was crushed, and there was no damage to the pushwire. Another pipeline was then used with a marksman microcatheter, and the procedure was completed without any reported issues. 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 angiography sowed exclusion of the aneurysm. Ancillary devices include a phenom 27 microcatheter.
 
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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 Key10640184
MDR Text Key210180915
Report Number2029214-2020-01005
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAR
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,Followup,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-16
Device Catalogue NumberPED2-400-16
Device Lot NumberA874053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2019
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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