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 Obstruction/Occlusion (2422)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: cai j, xu h, xiao r, hu l, xu p, guo x, xie y, pan m, tang j, gong q, liu y, su r, deng j, wang l.Rescue intracranial stenting for acute ischemic stroke after the failure of mechanical thrombectomy: a systematic review, meta-analysis, and trial sequential analysis.Front neurol.2023 jan 25;14:1023089.Doi: 10.3389/fneur.2023.1023089.Pmid: 36761342; pmcid: pmc9905111.Section d.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section e.1: the initial reporter phone is not available / reported.Section e.1: initial reporter address line 2: department of diagnostic imaging and interventional radiology.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Although no specific intervention is stated, it is clinically reasonable to assume an intervention would be provided in the case of a re-occlusion at the stent site.The event is being reported to the us fda as a conservative measure.The complaint will be updated with any additional information received from performing follow-up activity with the corresponding author, and reportability for the us fda will be reassessed.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.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 and the following citation was reviewed: cai j, xu h, xiao r, hu l, xu p, guo x, xie y, pan m, tang j, gong q, liu y, su r, deng j, wang l.Rescue intracranial stenting for acute ischemic stroke after the failure of mechanical thrombectomy: a systematic review, meta-analysis, and trial sequential analysis.Front neurol.2023 jan 25;14:1023089.Doi: 10.3389/fneur.2023.1023089.Pmid: 36761342; pmcid: pmc9905111.Purpose: to evaluate the clinical and angiographic outcome of permanent intracranial stenting as rescue therapy for acute ischaemic stroke (ais) after failed mechanical thrombectomy (mt).Materials and methods: e retrospectively reviewed collected records of patients treated with intracranial stents for ais after failed mt in our department between 2013 and 2017.Cerenovus devices that were used in this study: enterprise stents non-cerenovus devices that were also used in this study: self-expanding stents leo baby stent (balt), drug-eluting coronary stents (des) xience stent (abbott vascular, abbott park, il, usa) and coroflex stent (b.Braun melsungen ag, melsungen, germany); the bare metal balloon-mounted stent pharos vitesse (micrus endovascular, san jose, ca, usa) adverse event(s) and provided interventions for enterprise stent: qty 1 asymptomatic early stent occlusion (specific intervention not stated in article) this complaint will capture all adverse events potentially associated with cnv devices.Any adverse events associated with competitor or unknown products or attributed to the patient¿s preexisting conditions will be excluded. .

• 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): CERENOVUS, INC.; 325 paramount dr.; parque industrial salvacar; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16934191
• MDR Text Key: 315268797
• Report Number: 3008114965-2023-00296
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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: 05/03/2023
• 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: BARE MTL BLLN-MTD STN PHAROS VITESSE (MICRUS).; COROFLEX STENT (B. BRAUN MELSUNGEN AG).; DRUG-ELUTING CORONARY STENTS XIENCE STENT (ABBOTT).; ENTERPRISE STENTS.; SELF-EXPANDING STENTS LEO BABY STENT (BALT).
• Patient Outcome(s): Life Threatening