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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 FA-77375-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Therapeutic Response, Decreased (2271)
Event Date 02/28/2015
Event Type  Injury  
Manufacturer Narrative
Kerolus, m. , kasliwal, m. K. , <(>&<)> lopes, d. K. (2015). Persistent aneurysm growth following pipeline embolization device assisted coiling of a fusiform vertebral artery aneurysm: a word of caution! neurointervention, 10(1), 28. Doi:10. 5469/neuroint. 2015. 10. 1. 28. The pipeline embolization device (ped) performed as intended as indicated by successful implantation in the treatment of a fusiform, vertebral artery aneurysm. The ped remains implanted in the patient; product analysis cannot be performed. Based on the information provided in the article, there does not appear to have been any defect of the device during use. Aneurysm enlargement occurred in the patient post-procedure and its cause could not be conclusively determined from the provided information. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found a report of retreatment after pipeline embolization device (ped) implantation. The patient was admitted to the neuroscience intensive care unit with a hunt <(>&<)> hess grade 4/fisher grade 3 sah. The patient had a history of uncontrolled hypertension. An extraventricular drain (evd) was placed on admission and a digital subtraction angiography (dsa) was performed which demonstrated presence of the right vertebral artery fusiform aneurysm with the posterior inferior cerebellar artery (pica) arising from the base of a focal dilatation from the fusiform aneurysm segment. The patient underwent coil embolization as well as placement of a ped (3. 75x18mm), which covered the aneurysm for vessel remodeling. A raymond class ii occlusion of the focal dilatation arising from the fusiform aneurysm was achieved. The patient was loaded with aspirin and clopidogrel during the procedure. The evd was converted to a ventriculo-peritoneal shunt before the patient was discharged home in a good neurological condition. The patient was alert and oriented with no focal deficits at discharge except presence of right sided sixth cranial nerve palsy. Dual antiplatelet agents were prescribed for 6 months following the procedure. Six months post-procedure, routine follow-up angiography showed coil compaction as well as enlargement and regrowth of both the focal dilatation and the fusiform aneurysm without migration of the pipeline. The patient was asymptomatic. The patient underwent placement of three additional overlapping peds to increase the overall coverage area and further reduce shear stress. The patient was discharged home with no new neurological deficits. Three months after retreatment, follow-up angiography showed no residual aneurysm and clinical examination showed no neurological deficits.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key6902841
MDR Text Key87723758
Report Number2029214-2017-01085
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFA-77375-18
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 Received09/05/2017
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: 09/28/2017 Patient Sequence Number: 1
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