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); Intracranial Hemorrhage (1891); Thromboembolism (2654); Vascular Dissection (3160); Restenosis (4576)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: gao f, sun x, guo x, li d, xu gd, miao zr.Endovascular recanalization of symptomatic nonacute intracranial internal carotid artery occlusion: proposal of a new angiographic classification.Ajnr am j neuroradiol.2021 jan;42(2):299-305.Doi: 10.3174/ajnr.A6928.Epub 2020 dec 24.Pmid: 33361380; pmcid: pmc7872178.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 nonacute intracranial ica occlusion.With the information provided, it is not possible to determine the root cause of the events.However, there are patient, procedural, and pharmacological factors that may have contributed.There is no indication that the device (s) malfunctioned or that the events were 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.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: gao f, sun x, guo x, li d, xu gd, miao zr.Endovascular recanalization of symptomatic nonacute intracranial internal carotid artery occlusion: proposal of a new angiographic classification.Ajnr am j neuroradiol.2021 jan;42(2):299-305.Doi: 10.3174/ajnr.A6928.Epub 2020 dec 24.Pmid: 33361380; pmcid: pmc7872178.Objective and methods: the purpose of this study was to report multicenter clinical results of endovascular recanalization for medically refractory, nonacute, intracranial internal carotid artery (ica) occlusion and to propose a new angiographic classification to explore which subgroups of patients are most amenable to this treatment.From january 2015 to december 2019, thirty-six consecutive patients who underwent endovascular recanalization for refractory, nonacute, atherosclerotic intracranial ica occlusion at 3 stroke centers were analyzed retrospectively.The patients were divided into 3 types according to an angiographic classification.Rates of technical success, periprocedural complications, and any stroke or death within 30 days along with follow-up results were evaluated.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: synchro microwire (stryker), transend ex 014 205 soft tip microwire (stryker), echelon-10 microcatheter (medtronic), excelsior sl-10, microcatheter (stryker), gateway angioplasty balloon (stryker), wingspan stent (stryker), neuroform ez stent (stryker) 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: two patients had reperfusion hemorrhage 3 and 4 hours after successful recanalization; their symptoms deteriorated rapidly, and they died.Two patients underwent vascular dissection, and the operation was terminated because the guidewire could not pass through the occlusion to the distal vascular true lumen.One patient had mild ischemic stroke (nihss 3) after the operation, and the other one was asymptomatic.One patient experienced left-limb weakness (nihss 4) five days after successful recanalization, and transcranial doppler showed patency of the treated right ica.Per table 2, this patient experienced thrombosis.The median clinical follow-up period was 12 months.Stroke or death occurred at a rate of 7.4% (2/27) during follow-up.One patient each experienced ipsilateral ischemic stroke at 3 and 6 months after the operation, and cta revealed in-stent restenosis; the symptoms improved after drug and rehabilitation treatment (mrs 1).The median imaging follow-up period was 12 months (iqr ¼ 3.00¿12.00 months).Four patients (15.4%, 4/26) developed in-stent restenosis: two were symptomatic, and the other 2 were asymptomatic.

Manufacturer Narrative

Manufacturer¿s ref.(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: 12956945
• MDR Text Key: 287823885
• Report Number: 3008114965-2021-00637
• 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: 12/07/2021
• 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: 01/12/2022
• 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: ECHELON-10 MICROCATHETER (MEDTRONIC); EXCELSIOR SL-10, MICROCATHETER (STRYKER); GATEWAY ANGIOPLASTY BALLOON (STRYKER); NEUROFORM EZ STENT (STRYKER); SYNCHRO MICROWIRE (STRYKER); TRANSEND EX 014 205 SOFT TIP MICROWIRE (STRYKER); WINGSPAN STENT (STRYKER)
• Patient Outcome(s): Life Threatening