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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 PED2-500-30
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2020
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 failed to open. The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the left internal carotid artery with a max d iameter of 8. 35mm and a 1. 08mm neck diameter. It was noted the patient's vessel tortuosity was minimal. It was reported that the devices were prepared per the instructions for use (ifu). The microcatheter was placed in the proximal segment of the middle cerebral artery (mca). The pipeline stent was then delivered through the catheter and the distal end of the stent was pushed out but failed to open. The system was repositioned to a more proximal location in the mca, fully resheathed, and deployed without the distal end opening. Less than 50% of the stent was deployed, and it was not in a bend. The system was repositioned in the ica distal to the landing zone, but the pipeline still failed to open. It seemed the distal end was stuck to the delivery wire. The distal end of the stent opened slightly but was in a funnel shape. Finally, the stent was resheathed and removed from the patient. Another device was then used to successfully complete the procedure, and there was no injury to the patient as a result of the event. Post-procedure angiographic results showed full perfusion and no problems. Ancillary devices include an envoy 7f, navien a+ 058, phenom27, synchro 14.
 
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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 Key10365845
MDR Text Key202944039
Report Number2029214-2020-00768
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/20/2021
Device Model NumberPED2-500-30
Device Catalogue NumberPED2-500-30
Device Lot NumberA743622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2018
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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