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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PIPELINE EMBOLIZATION DEVICE

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MEDTRONIC PIPELINE EMBOLIZATION DEVICE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dementia (1808); Memory Loss/Impairment (1958); Neurological Deficit/Dysfunction (1982); Confusion/ Disorientation (2553)
Event Date 06/10/2015
Event Type  Injury  
Event Description
Pipeline embolization device placement with neurosurgeon/neuroradiologist (b)(6) md (b)(6). Following placement procedure, dr (b)(6) informed pt's spouse that there was an area of concern with possible vasculitis and a cta would be ordered cta with radiologist impression noting if pt is stable and clinically stability modality of choice, mra, to be performed. The mra was not ordered or performed at time of pt symptoms in nsicu-confusion, temporary mutism, writing intelligible words, agitation, retrograde amnesia. Pt discharged. (b)(6) md ordered mri in (b)(6) 2015 with indication, "dementia, vascular etiology suspected. " mri performed approx (b)(6) 2015. No f/u provided to pt. Pt seen by (b)(6) md co-chair of dept of neurology on (b)(6) 2015 with cognitive issues confirmed, "do not schedule f/u appointment," when on discharge instruction sheet. Why wasn't mra performed as certainly clinically indicated with pt symptomology, why discharged. Pt taken by ambulance to another facility within 5 hours of discharge and as documented in (b)(6) medical center chart, (b)(6) icu staff informed (b)(6) er staff that pt was agitated and refused to speak to them. Then why was pt discharged with mental status changes after neurological procedure performed (ped placement) as is the standard of care, especially in neurosurgical intensive care unit with one hour neuro checks required. "who was protected, the surgeon, (b)(6), medtronic, why didn't dr. (b)(6) place consult to (b)(6) brain injury center. Please find out. ".
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceEMBOLIZATION DEVICE
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6331451
MDR Text Key67653610
Report NumberMW5067886
Device Sequence Number1
Product Code OUT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/13/2017 Patient Sequence Number: 1
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