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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Neurological Deficit/Dysfunction (1982); Numbness (2415)
Event Date 09/02/2014
Event Type  Injury  
Event Description

Article/literature: zanaty m. Et al. Intra-aneurysmal thrombus modification after flow-diversion. J clin neurosci. 2015 jan;22(1):105-10. Covidien received the following through a review of literature: there were 3 adverse events reported in the article: 1 patient experienced transient worsening of his diplopia after ped placement which was treated with steroid therapy and the patient became completely asymptomatic by the time of his 1 year follow-up; 1 patient suffered from chronic headache that got worse in the months following treatment; and 1 patient experienced lower extremity numbness as the thrombus increased in size. Abstract flow diversion has been successfully used to treat large and giant intracranial aneurysms that present with mass effect. We conducted a retrospective review, evaluating the modification of thrombi in this aneurysm type after treatment with the pipeline embolization device (ev3 endovascular, plymouth, mn, usa) and the effects of these modifications on symptoms. Eight patients, seven of whom were female, harbored eight partially thrombosed large or giant aneurysms. Five of the eight aneurysms presented with symptomatic mass effect. At 1 year follow-up, complete occlusion occurred in 75% (6/8) of patients. On average, the longest thrombus diameter measured 22. 31 mm before treatment and 14. 05 mm 1 year afterwards. Seven of the eight thrombi regressed, as did their aneurysms. All six patients with shrunken thrombi had tremendous symptom improvement and became asymptomatic in the following year. The current findings seem to reflect the size variation of the intra-aneurysmal thrombus rather than the size of the aneurysm itself.

 
Manufacturer Narrative

Article website: http://www. Sciencedirect. Com/science/article/pii/s0967586814003737. The lot history record review was not possible since the lot numbers were not reported. The devices will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined. There were limited information about the device and/or the patient, therefore, all three serious adverse events were captured in this event. Attempts were made to gather more information from the author regarding these adverse events.

 
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Brand NamePIPELINE EMBOLIZATION DEVICE
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
9775 toledo way
irvine, CA 92618
MDR Report Key4490209
MDR Text Key5495881
Report Number2029214-2015-00097
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 01/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPIPELINE
Device LOT NumberNOT REPORTED
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/08/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 02/06/2015 Patient Sequence Number: 1
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