MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Transient Ischemic Attack (2109); Thromboembolism (2654); Restenosis (4576)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is from a literature source.The citation is as follows: fan w, li b, qu x, jiang b, rong j, liu y.Recanalization of symptomatic chronic internal carotid artery occlusions by hybrid treatment.Clin neurol neurosurg.2021 aug;207:106752.Doi: 10.1016/j.Clineuro.2021.106752.Epub 2021 jun 8.Pmid: 34144464.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter phone is not available.(b)(4).The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The enterprise vascular reconstruction device (vrd) is intended for use with occlusive devices in the treatment of intracranial aneurysms.It is not intended for use as a stand-alone device, i.E., without subsequent coil embolization of the aneurysm.This stent was used off-label for the treatment of symptomatic chronic internal carotid artery occlusion.There is no indication that the enterprise malfunctioned or that these events are related to the device design or manufacturing process.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

This complaint is from a literature source.The citation is as follows: fan w, li b, qu x, jiang b, rong j, liu y.Recanalization of symptomatic chronic internal carotid artery occlusions by hybrid treatment.Clin neurol neurosurg.2021 aug;207:106752.Doi: 10.1016/j.Clineuro.2021.106752.Epub 2021 jun 8.Pmid: 34144464.Objective and methods: the purpose of the study was to evaluate the efficacy and safety of hybrid revascularization by carotid endarterectomy and endovascular intervention in the treatment of chronic internal carotid artery occlusion (icao).A retrospective analysis was performed of patients who received hybrid treatment for symptomatic chronic icao between december 2016 and december 2018.Fifty-six patients with long-segment icao were enrolled and divided into the short duration (1¿3 months) and long icao duration (>3 months) groups, and their clinical and angiographic data were analyzed.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent other cerenovus devices that were also used in this study: n/a non-cerenovus devices that were also used in this study: 0.014-inch ¿platinum¿ micro-guidewire (ev3 inc), 0.017-inch sl-10 microcatheter (boston scientific), wingspan stent (boston scientific), wallstent stent (boston scientific), protege stent (ev3 inc) there is insufficient information within the text of this article to identify which devices (s) (cerenovus or non-cerenovus) are associated with the reported complications.Exact quantities cannot be determined accurately as the article does not provide adequate information.Adverse event(s) and provided interventions: five patients had mild restenosis during the 6-month follow-up period, and one had re-occlusion; none of these patients presented severe ischemic stroke due to the target vessel in the follow-up period.The degree of restenosis was between 50% and 70% revascularization was not performed on these patients.Aspirin and statin were administrated to control the recurrence of neurological events.Transient ischemic attack (tia) was observed in 7 patients and two patients suffered from mild stroke with small scale infarction as confirmed via dwi examination.Two patients had recurrent tia due to the occluded carotid artery.Intraoperative thromboembolism of the distal vessel (m2 branch) occurred in 1 patient which may have been embolus dislodged during vessel dilatation.This patient had no obvious symptoms of cerebral infarction after the operation.Early phase postoperative hypertension was noticed in 11 patients.Iv vasoactive medicine was given when postoperative blood pressure was above 160/100 mmhg and could not be controlled with antihypertensive medications.Subarachnoid hemorrhage (sah) was observed in 2 patients, which may have been due to postoperative hyperperfusion and uncontrolled hypertension.Ct examination showed that the area of hemorrhage was not large, and anti-platelet drugs were stopped immediately.The hemorrhage was nearly absorbed one week later, and the patient had no residual neurological deficiencies.Cervical hemorrhage was observed postoperatively in 1 patient under double anti-platelet therapy, which may be due to oozing of blood after complete revascularization, partially compressing the blood vessels and trachea.Anti-platelet drugs were stopped immediately, and decompression was conducted by reopening the incision.Among the patients who underwent successful recanalization, one patient died of acute myocardial infarction within 24 h after operation.There is insufficient information within the text of this article to identify which devices (s) (cerenovus or non-cerenovus) are associated with the reported complications.Exact quantities cannot be determined accurately as the article does not provide adequate information.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12964787
• MDR Text Key: 286928053
• Report Number: 3008114965-2021-00642
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 0.014-INCH ¿PLATINUM¿ MICRO-GUIDEWIRE (EV3 INC); 0.017-INCH SL-10 MICROCATHETER (BOSTON SCIENTIFIC); PROTEGE STENT (EV3 INC); WALLSTENT STENT (BOSTON SCIENTIFIC); WINGSPAN STENT (BOSTON SCIENTIFIC)
• Patient Outcome(s): Life Threatening