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 Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: zhang k, li tx, wang zl, gao bl, gu jj, gao hl, wang yf, xia jc.Factors affecting in-stent restenosis after angioplasty with the enterprise stent for intracranial atherosclerotic diseases.Sci rep.2021 may 18;11(1):10479.Doi: 10.1038/s41598-021-89670-x.Pmid: 34006896; pmcid: pmc8131349.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 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 symptomatic intracranial atherosclerotic stenosis.Since the relationship of the device to the periprocedural deaths cannot be excluded, the events meet mdr reporting criteria.There is no indication that the enterprise stents malfunctioned, or that the events were related to a device design or manufacturing issue.This complaint will be reassessed if new information becomes available.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: zhang k, li tx, wang zl, gao bl, gu jj, gao hl, wang yf, xia jc.Factors affecting in-stent restenosis after angioplasty with the enterprise stent for intracranial atherosclerotic diseases.Sci rep.2021 may 18;11(1):10479.Doi: 10.1038/s41598-021-89670-x.Pmid: 34006896; pmcid: pmc8131349.Objective and methods: this study investigated factors affecting the safety and in-stent restenosis after intracranial stent angioplasty using the enterprise stent for symptomatic intracranial atherosclerotic stenosis.Between january 2017 and march 2019, patients with intracranial atherosclerotic stenosis treated with enterprise stent angioplasty were enrolled, including 400 patients in the modeling group and 89 patients in the validation group.The first follow-up angiography was performed in 348 (87.0%) patients with 359 lesions, with a follow-up time ranging from 3.5¿14 months (mean 5.7 months).Lot, model or catalog numbers are not available, but the suspected cerenovus device (s) possibly associated with reported adverse events: enterprise stent.Concomitant cerenovus devices that were also used in this study: n/a.Concomitant non-cerenovus devices that were also used in this study: transcend microwire (0.014, 205 cm, stryker); gateway balloon catheter (stryker).Adverse event(s) and provided interventions: during the 30-day periprocedural period: ischemic stroke occurred in 13 patients.Hemorrhagic stroke occurred in three patients.Death occurred in two patients.During the follow-up period: in-stent restenosis occurred in 62 lesions.In-stent restenosis refers to a lesion demonstrating stenosis greater than 50% adjacent to or within the stent and absolute luminal loss greater than 20% on follow-up imaging.

• 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: 13546691
• MDR Text Key: 285799719
• Report Number: 3008114965-2022-00127
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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: 02/14/2022
• 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 CATHETER (STRYKER); TRANSCEND MICROWIRE (0.014, 205 CM, STRYKER)
• Patient Outcome(s): Death