MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-425-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neurological Deficit/Dysfunction (1982); Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following report through literature review of ¿treatment of ruptured blood blister-like aneurysms of the internal carotid artery with flow-diverting stents: case report and review of pharmacological management¿ (kristopher a.Lyon, md, samantha dayawansa, md phd, ethan a.Benardete, md phd).A (b)(6) woman with no past medical history presented with a severe headache and hypotension after being found unresponsive by her family (hunt and hess grade 4).A computed tomography (ct) head scan revealed diffuse, thick sah (fisher grade 3).Ct angiography of the head suggested a small, wide-necked, superiorly projecting aneurysm of the distal right para-ophthalmic segment of the ica.Digital subtraction angiography (dsa) confirmed a ruptured 2.5mm×2.5mm×2.5mm blood-blister like aneurysm (bbla) of the right ica.On post-bleed day 3, the patient was brought to the angiography suite, and after induction of general anesthesia, she was given 650 mg aspirin and 180 mg of ticagrelor via a nasogastric tube.She was set up for somatosensory evoked potentials (ssep) and electroencephalography (eeg) monitoring throughout the case.After confirmation of the aneurysm with standard angiography, a coaxial system of a neuron max 088 catheter and a navien 058 catheter was used to access the right ica.The patient was bolused with intravenous heparin (70 units/kg) and the activated clotting time (act) was maintained at twice control.The patient was then given a single loading dose of 180 ¿g/kg eptifibatide (merck & co., inc., kenilworth, nj), and an infusion was started at 2 ¿g/kg/min for 10 min prior to deployment of the flow-diverting stent.Under roadmap views, a marksman catheter (medtronic, inc.) was used to deliver a 4.25×12mm pipeline flex.Excellent placement of the stent was seen across the aneurysm with good apposition to the carotid artery wall.Somatosensory evoked potentials (ssep) and electroencephalography (eeg) monitoring remained stable at baseline.The femoral artery sheath was secured and left in place while the eptifibatide drip was continued for 12 h and the effects of the heparin wore off.The sheath was then removed without difficulty.Forty-eight hours after the procedure, platelet response testing (verifynow, accriva diagnostics, inc., bedford, ma) was used to document adequate response to aspirin andticagrelor (aspirin response<(><<)>500, p2y12 response<(><<)>194).On post-bleed day 7, the patient developed vasospasm on ct angiography and transcranial doppler.She was treated with induced hypertension to keep systolic blood pressure between 160 and 200mmhg for approximately 7 days.Ct angiography at this time also demonstrated that the aneurysm had not yet occluded.In fact, it appeared to have slightly enlarged.Following a 21-day course in the hospital, the patient was discharged home with no neurological deficits.She was followed up in clinic approximately 10 days after the discharge (post op day 28) for complaints of visual obscurations and mild lethargy.A non-contrast ct scan demonstrated hydrocephalus.Two doses of ticagrelor were held, and she underwent placement of a ventriculoperitoneal (vp) shunt without complication on post op day 30.She was again seen at a 6-month post-operative visit, and she was neurologically intact.Follow-up magnetic resonance (mr) angiography and dsa at that time showed occlusion of her right ica blister aneurysm with no evidence of residual or recurrent aneurysm.Flow-diverting stents (fds) offer a new way to treat ruptured bbla, as this technology allows endoluminal reconstruction of the parent vessel without entering the weak aneurysm dome.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8764538
• MDR Text Key: 150153569
• Report Number: 2029214-2019-00682
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-425-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR