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

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Operative neurosurgery, volume 17, issue 5, november 2019, pages 491 -496, https://doi.Org/10.1093/ons/opz023 ¿mechanical thrombectomy of acutely occluded flow diverters¿ edgar a.Samaniego, sudeepta dandapat, jorge a.Roa, mario zanaty, daichi nakagawa, david m.Hasan.Patient 1: a (b)(6)-yr-old woman presented with subarachnoid hemorrhage secondary to a ruptured right internal carotid artery(ica) terminus aneurysm.She underwent microsurgical clipping.Post clipping magnetic resonance angiography demonstrated no residual aneurysm 1 yr after the procedure.A diagnostic subtraction angiography (dsa) performed 5 yr after clipping demonstrated a large saccular aneurysm at the right ica terminus, with displacement of the previously placed clip.An area of stenosis at the site of the previous clip was visualized in the right middle cerebral artery (mca).Based on the angiographic findings, it was decided to proceed with coiling and ped embolization of the aneurysm.As per protocol, the patient was given 3000 iu of iv heparin after groin access has been achieved and redosed with 1000 iu after every hour.Dual antiplatelet therapy was started at least 7 d before the procedure.She underwent ped and coil embolization of the aneurysm.Within 30 min of being in the recovery unit, she developed right gaze preference, left neglect, and left hemiparesis (nihss 15).She underwent mechanical thrombectomy with three passes ¿ described below, achieving complete recanalization.She had a remarkable recovery with no residual deficits and was discharged home the following day.At her 3 mo follow-up in clinic, she was independent in her activities of daily living with a modified rankin scale (mrs) of zero.Patient 2: a (b)(6)-yr-old man underwent microsurgical clipping of a right ica cave unruptured aneurysm.A post clipping dsa performed 15 d after the procedure demonstrated a residual aneurysm.Despite his recent surgical clipping, the patient requested endovascular embolization of the aneurysm due to a strong family history of aneurysmal subarachnoid hemorrhage.He was started on a 7-d course of dual antiplatelets and underwent ped embolization of the residual aneurysm without any complications.Within an hour of the procedure, he developed right gaze preference, left neglect.And left hemiparesis (nihss 14).He underwent mechanical thrombectomy with one pass ¿ described below, achieving complete recanalization.He had mild residual weakness on the left side and required standby assist during ambulation.He was discharged to acute rehabilitation with an mrs of 2.Technical procedure: thrombectomy: a bolus infusion (0.4 mcg/kg over 15 min) of iv tirofiban (medicure, (b)(4)) was administered followed by a maintenance drip (0.1 mcg/kg/min) before thrombectomy.The procedures were performed under monitored anesthesia care, as previously described.Arterial access was obtained by placing a 7 french short sheath in the right common femoral artery.Then a 6 french envoy catheter was advanced to the distal cervical ica segment using a 0.038 guide-wire.A marksman microcatheter over a synchro 2 soft microwire was advanced inside the guide catheter and used to cross the occluded ped.The tip of the synchro 2 microwire was shaped like a ¿u¿ in order to cross the previously placed ped and navigate distally.Following microwire removal, the distal end of the 6 × 40 mm solitaire stentriever was deployed distal to the occluded ped.The proximal end of the stentriever ended within the mid-segment of the ped.However, we were unable to pull back the stentriever due to increased friction against the newly deployed ped.The solitaire stentriever was then recaptured and the marksman microcatheter pulled back within the ped.The solitaire stentriever was then slowly deployed inside the ped.The distal end of the solitaire stentriever was aligned with the distal end of the ped.In this way, the entire stentriever was deployed inside the ped, instead of deploying the stentriever in the vessel and within the ped.We then performed thrombectomy by pulling the microcatheter and stentriever within the envoy guide catheter.Manual aspiration was performed thought the envoy catheter, while the microcatheter and stentriever were slowly pulled back.The ped remained in a stable position.It was easier to remove the stentriever if deployed completely inside the ped.Repeat thrombectomies were performed if follow up dsa demonstrated residual thrombus inside the device.A tirofiban drip was continued for 4 h after the procedure.Responsiveness to clopidogrel was subtherapeutic, and patients were started on ticagrelor along with continuation of aspirin while stopping clopidogrel.Institutional review board approval was granted, as these cases are part of a quality and improvement project to track technical and clinical outcomes of patients with intracranial aneurysms.Patient consent was waived, as we do not include identifiable information.

• Brand Name: PIPELINE
• 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 ; 9496801345
• MDR Report Key: 9862887
• MDR Text Key: 193412308
• Report Number: 2029214-2020-00272
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• 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