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 Intracranial Hemorrhage (1891); Ischemia Stroke (4418)

Event Date 10/26/2020

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: gao f, guo x, sun x, liu y, wu y, miao z.Dual-roadmap guidance for endovascular recanalization of medically refractory non-acute intracranial arterial occlusions: consecutive multicenter series and technical review.J neurointerv surg.2021 oct;13(10):889-893.Doi: 10.1136/neurintsurg-2020-016754.Epub 2020 oct 26.Pmid: 33106320.Date of death: the date of death is not known / documented in the article.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 address line 1 is not known.Initial reporter address line 2: (b)(6).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 non-acute intracranial artery occlusion.There is no indication that the enterprise malfunctioned or that the 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: gao f, guo x, sun x, liu y, wu y, miao z.Dual-roadmap guidance for endovascular recanalization of medically refractory non-acute intracranial arterial occlusions: consecutive multicenter series and technical review.J neurointerv surg.2021 oct;13(10):889-893.Doi: 10.1136/neurintsurg-2020-016754.Epub 2020 oct 26.Pmid: 33106320.Objective and methods: the article reports a multicenter clinical experience of dual-roadmap guidance for endovascular recanalization of non-acute intracranial artery occlusion focusing on the technical feasibility and safety.From january 2014 to december 2019, 52 consecutive patients with medically refractory atherosclerotic non-acute intracranial artery occlusion who underwent endovascular recanalization under dual-roadmap guidance in three large regional referral stroke centers were analyzed retrospectively.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: gateway balloon (stryker), neuroform ez stent (stryker), wingspan 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: one patient experienced acute in-stent thrombosis during the operation and was treated with intra-arterial tirofiban and recombinant tissue plasminogen activator thrombolytic therapy followed by recanalization, resulting in postoperative new infarction (national institutes of health stroke scale (nihss) 3).One patient suffered from reperfusion hemorrhage after successful recanalization and died.One patient experienced ipsilateral ischemic stroke at 6 months after the operation; cta revealed in-stent restenosis, and his symptoms improved after drug and rehabilitation treatment (mrs 1).One patient died from acute ischemic stroke 6 months after successful recanalization of the dominant left vertebral artery, with a ct showing large brainstem infarction.The median imaging follow-up period was 12 months.Five patients developed in-stent restenosis, one of whom was symptomatic and the other four were asymptomatic.Restenosis was defined as >50% stenosis within the implanted stent and >20% absolute luminal loss on cta or dsa.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6) 2022 and (b)(6) 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 (b)(6) 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: 12978783
• MDR Text Key: 282089620
• Report Number: 3008114965-2021-00655
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• 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: GATEWAY BALLOON (STRYKER).; NEUROFORM EZ STENT (STRYKER).; WINGSPAN STENT (STRYKER).
• Patient Outcome(s): Death