MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

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

Patient Problem Septic Shock (2068)

Event Date 01/05/2016

Event Type  Death  

Manufacturer Narrative

Product complaint #: (b)(4).Literature article emergent revascularization of acute tandem vertebrobasilar occlusions: endovascular approaches and technical considerations-confirming the role of vertebral artery ostium stenosis as a cause of vertebrobasilar stroke reviewed.Cohen je, leker rr, gomori jm, eichel r, rajz g, moscovici s, itshayek e.J clin neurosci.2016 dec;34:70-76.Doi: 10.1016/j.Jocn.2016.05.005.Epub 2016 aug 10.Pmid: 27522497.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00482.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Literature article emergent revascularization of acute tandem vertebrobasilar occlusions: endovascular approaches and technical considerations-confirming the role of vertebral artery ostium stenosis as a cause of vertebrobasilar stroke reviewed.Cohen je, leker rr, gomori jm, eichel r, rajz g, moscovici s, itshayek e.J clin neurosci.2016 dec;34:70-76.Doi: 10.1016/j.Jocn.2016.05.005.Epub 2016 aug 10.Pmid: 27522497.Objective and methods: patients suffering from acute atherothrombotic occlusion of the proximal vertebral artery (va) and concomitant basilar artery (ba) occlusion present a grim prognosis.We describe our experience in the endovascular recanalization of tandem vertebrobasilar occlusions using endovascular techniques.The ba was accessed through the normal va (clean-road) or the occluded, thrombotic va (dirty-road), and stentriever-based thrombectomy was performed using antegrade or reverse revascularization variants.Seven patients underwent successful stentriever-assisted mechanical thrombectomy of the ba and five sustained concomitant va revascularization.Stroke onset to endovascular intervention initiation (time-to-treatment) ranged from 4.5¿13 hours (mean 8.6).In two of seven patients, the ba occlusion was approached with a ¿clean-road¿ approach via the contralateral va; in five of seven patients, a ¿dirty-road¿ approach via the occluded va was used.Mean time-to-recanalization was 66 minutes (range 55¿82).There were no perforations, iatrogenic vessel dissections, or other technical complications.Four patients presented mild-to-moderate disability (modified rankin scale [mrs] 0¿3) at 3 months, one remained with moderate-to-severe disability (mrs 4), and two patients died on days 9 and 23 after their strokes.Follow-up ranged from 6¿45 months (mean 24 months).In selected patients with acute va-ba occlusion, stentriever-based thrombectomy performed through either the patent or the occluded va, may be feasible, effective, and safe.Clinical outcomes in these patients seem to equipoise the neurological outcome of patients with successful revascularization for isolated ba occlusion.This unique pair of occlusions confirms the role of va ostium stenosis as a cause of vertebrobasilar stroke.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: envoy catheter and enterprise neurostent.Other cerenovus devices that were also used in this study: rebar, ev3, plymouth, mn, usa; excel, stryker, kalamazoo, mi, usa; microguidewire, boston scientific, marlborough, ma, usa.Non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions:" patient number 3 died from septic shock 23 days after the procedure.An envoy catheter and enterprise neurostent was used during the procedure.

• Brand Name: UNKENTERPRISE2
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12563124
• MDR Text Key: 274312805
• Report Number: 1226348-2021-00064
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCEL, STRYKER; MICROGUIDEWIRE, BOSTON SCIENTIFIC; REBAR, EV3, PLYMOUTH
• Patient Outcome(s): Death