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 Thromboembolism (2654); Vascular Dissection (3160); Ischemia Stroke (4418); Restenosis (4576)

Event Date 03/04/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The citation is as follows: gao f, han j, guo x, sun x, ma n, miao z.Endovascular recanalization for non-acute basilar artery occlusions with progressive or recurrent ischemic symptoms: a multicenter clinical experience.J neurointerv surg.2021 mar 4:neurintsurg-2020-017213.Doi: 10.1136/neurintsurg-2020-017213.Epub ahead of print.Pmid: 33674396.Objective and methods: the article reports a multicenter clinical experience of endovascular recanalization for symptomatic non-acute bao and propose an angiographic grouping to determine which patient subgroup most benefits from this treatment.Forty-two patients with non-acute bao with progressive or recurrent vertebrobasilar ischemic symptoms who underwent endovascular recanalization were retrospectively analyzed from january 2015 to december 2019.The rates of technical success, periprocedural complications and outcome, any stroke or death within 1month, and follow-up data were examined.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: excelsior sl-10 microcatheter (stryker), echelon-10 microcatheter (ev3), transend ex 014/205 soft tip microwire (boston scientific), synchro microwire (stryker), gateway balloon (2¿2.5mm; stryker), neuroform ez stent (stryker), wingspan stent (stryker).Adverse event(s) and provided interventions: one patient underwent vascular dissection during the recanalization, and the operation terminated unfavorably.The patient developed locked-in syndrome with worsening postprocedural symptoms, and cerebral mri revealed newly emerged infarcts in the brainstem.Periprocedural ischemic and perforator strokes were reported in four patients.Two patients had minor ischemic stroke (nihss score 3 or 4), which was relieved before discharge (mrs 1 & 2).The other two patients experienced major ischemic stroke.One patient suffered from a medullary lesion following the recanalization and experienced dysarthria, left hemiplegia, respiratory failure, and somnolence.The patient recovered gradually after ventilation and medical treatment, and achieved a mrs score of 3 before discharge.Another patient developed locked-in syndrome with gastrointestinal bleeding and pulmonary infection, and died 10 days after the operation.One patient developed acute stent thrombosis during the operation and was treated with recombinant tissue plasminogen activator and intra-arterial tirofiban followed by recanalization, leading to a new postprocedural infarction (nihss score 3).The median follow-up time was 1 year.During this period, two patients experienced ischemic stroke in the brainstem and ipsilateral cerebellum 3 or 6 months after recanalization.Cta demonstrated the occurrence of in-stent restenosis, and the symptoms were alleviated by rehabilitation and drug treatment (mrs scores 1 & 2).Four patients developed in-stent restenosis, which was asymptomatic in half of them.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: gao f, han j, guo x, sun x, ma n, miao z.Endovascular recanalization for non-acute basilar artery occlusions with progressive or recurrent ischemic symptoms: a multicenter clinical experience.J neurointerv surg.2021 mar 4:neurintsurg-2020-017213.Doi: 10.1136/neurintsurg-2020-017213.Epub ahead of print.Pmid: 33674396.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.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 non-acute bao.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.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 12-jan-2022 and 13-jan-2022, that changed the reportability of this complaint file.Additional information received on 12-jan-2022 was reviewed.The sales representative contacted the author and confirmed that the adverse events were not related to the cerenovus devices used in the study.No further information could be obtained.Confirmation was received on 13-jan-2022.The author (i.E., physician) thought the adverse events were not related to the cerenovus devices although they used cerenovus devices.No further information could be obtained.Based on the evaluation of the author that the events were not related to the cerenovus devices, the events no longer meet mdr reporting criteria.No further reports will be forthcoming.

• 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: 12964954
• MDR Text Key: 287413850
• Report Number: 3008114965-2021-00644
• 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,Followup
• Report Date: 01/17/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• 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
• Treatment: ECHELON-10 MICROCATHETER (EV3).; EXCELSIOR SL-10 MICROCATHETER (STRYKER).; GATEWAY BALLOON (2¿2.5MM, STRYKER).; NEUROFORM EZ STENT (STRYKER).; SYNCHRO MICROWIRE (STRYKER).; TRANSEND EX 014/205 MICROWIRE (BOSTON SCIENTIFIC).; WINGSPAN STENT (STRYKER).