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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 PED2-400-35
Device Problem Migration (4003)
Patient Problems Infarction, Cerebral (1771); Headache (1880); Occlusion (1984); Paralysis (1997)
Event Date 08/02/2020
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 migrated post-procedure and the patient experienced a cerebral infarction, paralysis, and headache. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the internal carotid artery with a max diameter of 10mm and a 4mm neck diameter. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy was performed, and the pru level was unknown. It was reported that implantation of the pipeline was performed on (b)(6) 2020. There was no problem observed on the ct after the initial procedure. It was noted the stent had opened evenly, and the ophthalmic artery, anterior choroidal artery side branch was covered by the pipeline. The patient was discharged after a two week hospital stay. Three days later, the patient was hospitalized for cerebral infarction, and it was found the distal end of the pipeline migrated from the middle cerebral artery to the anterior choroidal artery which was occluded. It was unknown when the migration occurred post-procedure, and it was in that state that paralysis remained at the time of the report. The patient also complained of headache due to a sudden thrombosis during hospitalization was a steroid was administered. According to confirmation after the patient was transferred to the hospital due to the cerebral infarction, the aneurysm was occluded by about half.

 
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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 Key10450055
MDR Text Key204351758
Report Number2029214-2020-00839
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeJA
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 09/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPED2-400-35
Device Catalogue NumberPED2-400-35
Device LOT NumberA839456
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/30/2019
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: 08/25/2020 Patient Sequence Number: 1
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