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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 PED2-325-18
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 06/20/2019
Event Type  Malfunction  
Manufacturer Narrative

This is a report for a similar device that is not marketed in the us. Device. Suspect medical device - similar device brand name = pipeline flex w/shield technology model # = ped2-325-18. The pipeline flex with shield device will not be returned as it remains in the patient; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. The procedure was successful and there was no device issue was reported during procedure. The event occurred in patient post procedure and cause of the device migration cannot be reliably determined. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information post procedure of embolization treatment, the pipeline flex with shield device migrated. It was reported that the patient underwent retreatment of the treated aneurysm. The patient was undergoing surgery for treatment of a saccular, terminal aneurysm in the midline basilar artery with a max diameter of 14mm, 7. 7mm neck diameter, 9mm dome height, 14mm dome width, parent artery diameter distal to aneurysm was 1. 3mm, and proximal was 3. 3mm. There were no reports of patient injury in association with this event.

 
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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 Key9949020
MDR Text Key202075370
Report Number2029214-2020-00355
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeHU
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 10/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPED2-325-18
Device Catalogue NumberPED2-325-18
Device LOT NumberA725774
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 Received09/22/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/18/2018
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: 04/10/2020 Patient Sequence Number: 1
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