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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 PED3-027-500-25
Device Problems Activation, Positioning or SeparationProblem (2906); Migration (4003)
Patient Problems Infarction, Cerebral (1771); Paresis (1998); Thrombosis (2100); Therapeutic Response, Decreased (2271)
Event Date 05/27/2020
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 vantage migrated after procedure and a thrombus was noted during dsa, which was considered to be life threatening. The issue was discovered due to left sided weakness experienced by the patient. As a result the patient was hospitalized, there was surgical intervention, and a blood transfusion. The vantage device was clotted and a pipeline flex implanted. The patient status was recovered at the time of the report. The event was listed as probably related to the procedure. Additional information received indicated the subject was hypertensive in the postop period requiring cardene for bp control and complaining of 8/10 right sided headache since the embolization partially relieved by analgesics. Mri that was performed the following day on (b)(6) 2020 showed right hemispheric stroke due to embolic shower from in stent thrombus after unruptured right superior hypophyseal aneurysm pipeline embolization, a right eye purple spot- suspect small embolic retinal shower.

 
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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 Key10138026
MDR Text Key194661299
Report Number2029214-2020-00536
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 HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPED3-027-500-25
Device Catalogue NumberPED3-027-500-25
Device LOT NumberA954559
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/10/2020 Patient Sequence Number: 1
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