MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Vascular Dissection (3160); Restenosis (4576)

Event Date 06/15/2021

Event Type  Injury  

Event Description

Guo x, wang l, liu j, yu l, ma y, fan c, zhang n, song l, miao z.Transradial approach using a distal access catheter without guiding support for symptomatic intracranial vertebral artery and basilar artery stenosis: a multicenter experience and technical procedure.J neurointerv surg.2021 jun 15:neurintsurg-2021-017635.Doi: 10.1136/neurintsurg-2021-017635.Epub ahead of print.Pmid: 34131051.Objective and methods: this article reports multicenter experience and technical procedures that directly used a distal access catheter (dac) via transradial approach (tra) for the treatment of symptomatic intracranial vertebral (va) and basilar (ba) artery stenosis.From january 2019 to december 2020, 92 consecutive patients with severe symptomatic intracranial va or ba stenosis were retrospectively collected and divided into two groups (tra group and transfemoral approach (tfa) group) for neurointerventional treatment.Stents used: wingspan in 53 cases, neuroform ez in 23 cases, and enterprise 2 in 16 cases.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise 2 stent other cerenovus devices that were also used in this study: n/a non-cerenovus devices that were also used in this study: wingspan stent system (stryker), neuroform ez stent (stryker), cordis 4f, 125cm multifunction angiographic catheter, catalyst 5f distal access catheter (stryker), 0.035 in, 180cm radifocus guidewire (terumo), excelsior sl-10 microcatheter (stryker), 0.014 in, 200cm synchro microwire (stryker), gateway balloon (stryker), cordis exoseal device (cordis corporation).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: perioperative events included 1 target vessel perforation, 1 symptomatic intracranial hemorrhage (sich), and 2 dissections.Complications within 30 days included 5 transient ischemic attack (tia)/stroke within the same vascular territory and 1 vascular-related death.Long-term complications included 6 ischemic stroke and death and 7 symptomatic in-stent restenosis (isr) = 50% and =20% absolute luminal loss.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Guo x, wang l, liu j, yu l, ma y, fan c, zhang n, song l, miao z.Transradial approach using a distal access catheter without guiding support for symptomatic intracranial vertebral artery and basilar artery stenosis: a multicenter experience and technical procedure.J neurointerv surg.2021 jun 15:neurintsurg-2021-017635.Doi: 10.1136/neurintsurg-2021-017635.Epub ahead of print.Pmid: 34131051.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 intracranial vertebral artery and basilar artery stenosis.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.

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: UNKENTERPRISE2
• 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: 12957813
• MDR Text Key: 288401019
• Report Number: 3008114965-2021-00639
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: UNKENTERPRISE2
• 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: 0.014 IN, 200CM SYNCHRO MICROWIRE (STRYKER).; 0.035 IN, 180CM RADIFOCUS GUIDEWIRE (TERUMO).; CATALYST 5F DISTAL ACCESS CATHETER (STRYKER).; CORDIS 4F, 125CM MULTIFUNCTION ANGIO CATHETER.; CORDIS EXOSEAL DEVICE (CORDIS CORPORATION).; EXCELSIOR SL-10 MICROCATHETER (STRYKER).; GATEWAY BALLOON (STRYKER).; NEUROFORM EZ STENT (STRYKER).; WINGSPAN STENT SYSTEM (STRYKER).
• Patient Outcome(s): Life Threatening