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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Paresis (1998)
Event Date 12/07/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis, as it was implanted in the patient and the delivery system was discarded at the site. Based on the reported information there was no device malfunction or deficiency. This event appears to be related to the patient's failure to follow the treating physician medical advice, the patient did not start the antiplatelet medication correctly. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that one-day post flow diverter procedure, the patient developed left side weakness. One-day post procedure, the patient woke up with weak left side movement. Tests were performed, and it had been discovered that a clot was present in the flow diverter and carotid artery. Aspiration was performed to remove the clot. All the clot was removed, but it was noticed a piece showered off from the carotid into the m1/m2 bifurcation. A mechanical thrombectomy device was then used to retrieve the small amount of clot, but there was difficulty with catheter access (competitor catheter), the microcatheter and mechanical thrombectomy device could only reach part of the clot, as a result of the competitor support catheter that was used. Tortuosity also limited the ability to get the catheter beyond the entire clot. The competitor catheter was deployed short of the entire length of clot. It was alleged that the patient did not taken the dapt, even though it was prescribed prior to the procedure.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7161228
MDR Text Key96329975
Report Number2029214-2018-00014
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/06/2020
Device Model NumberPED-450-35
Device Lot NumberA471829
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 Received12/07/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/07/2017
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: 01/03/2018 Patient Sequence Number: 1
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