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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 INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-425-18
Device Problems Positioning Failure (1158); Positioning Problem (3009)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 06/27/2019
Event Type  Injury  
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 placed perfectly during the first pass, but it was a bit distal and the stenosis couldn't be covered with it. During resheathing of the pipeline due to this issue, the microcatheter and pipeline pushed a bit hard into the artery wall. Then, during second deployment of the pipeline the physician noted that the device twisted, so they took the whole system out of the patient. Contrast injection performed showed a perforated ica, so they coiled the ica with coils 1 plug, and glue. The patient was undergoing surgery for treatment of an unruptured, saccular cavernous segment of the left ica with a max diameter of 4. 3mm. Dual antiplatelet treatment was administered which showed a pru level of 98%. Post procedure angiographic results showed an open acom, left ica closed with plug, coils, and glue. Distally of the left media was the small ischemic stroke, delay of 1. 6s regarding right media. Ancillary devices include a 6fr destination long sheath 90cm sheath, 6f benchmark 071mp, lot f89067 guide catheter, synhcro 0. 014" guidewire.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8765027
MDR Text Key150280925
Report Number2029214-2019-00683
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBE
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 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-425-18
Device Catalogue NumberPED2-425-18
Device Lot NumberA778693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/05/2019 Patient Sequence Number: 1
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