MAUDE Adverse Event Report: MEDTRONIC PIPELINE EMBOLIZATION DEVICE

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.".

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6331451
• MDR Text Key: 67653610
• Report Number: MW5067886
• Device Sequence Number: 1
• Product Code: OUT
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 70