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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 08/24/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a patient who has had stenosis of the parent artery following placement of a pipeline device on (b)(6) 2016; there were no device or procedural issues nor patient adverse event/symptoms were reported at time of the pipeline implantation surgery. The patient was treated for a saccular aneurysm of the left c3 cavernous sinus. The aneurysm max diameter was 24. 6mm and the neck diameter was 7. 3mm. The patient presented with unspecified cranial nerve disorder. It was reported that treatment did not resolve the patient's symptoms with mass effect (iii-vi disorder) being unchanged at follow up appointment on (b)(6) 2016. Stenosis thought to be related to the pipeline stent first at 6 month follow-up appointment on (b)(6) 2016. The patient was also seen (b)(6) 2018 and (b)(6) 2019 with noted optic nerve symptoms and mass effect (iii-vi disorder) marked unchanged per clinician report at each follow-up visit. Corrected rankin scale rating was 1 for all reported visits from date of surgery to most recent. The patient is treated with aspirin and clopidogrel.
 
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Brand NamePIPELINE FLEX
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
tricha miles
9775 toledo way
irvine,ca, MN 92618
7635140379
MDR Report Key10214721
MDR Text Key201190530
Report Number2029214-2020-00630
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/11/2018
Device Model NumberPED-475-35
Device Catalogue NumberPED-475-35
Device Lot NumberA146269
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/30/2020 Patient Sequence Number: 1
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