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 Thromboembolism (2654)

Event Date 10/07/2018

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: bender mt, vo cd, jiang b, campos jk, zarrin da, xu r, westbroek em, caplan jm, huang j, tamargo rj, lin lm, colby gp, coon al.Pipeline embolization for salvage treatment of previously stented residual and recurrent cerebral aneurysms.Interv neurol.2018 oct;7(6):359-369.Doi: 10.1159/000489018.Epub 2018 jun 1.Pmid: 30410513; pmcid: pmc6216715.This study assessed the safety and effectiveness of the pipeline embolization device (ped) for persistent and recurrent aneurysms previously treated with either a vascular reconstruction device (vrd) or a flow diverter (fd).Cases included previously vrd stent-coiled cases were re-treated.This complaint captures one of those cases that is noted where an enterprise stent was previously used.Cerenovus devices that were used in this study: enterprise stents non-cerenovus devices that were also used in this study: neuroform (stryker) and wallstent (boston scientific).Adverse event(s) and provided interventions for enterprise stent: patient #18 qty 1 asymptomatic proximal ica occlusion.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. .

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: bender mt, vo cd, jiang b, campos jk, zarrin da, xu r, westbroek em, caplan jm, huang j, tamargo rj, lin lm, colby gp, coon al.Pipeline embolization for salvage treatment of previously stented residual and recurrent cerebral aneurysms.Interv neurol.2018 oct;7(6):359-369.Doi: 10.1159/000489018.Epub 2018 jun 1.Pmid: 30410513; pmcid: pmc6216715.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 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 occlusion at/near the stent site.The type of occlusion is not specified and being coded as a cerebral thrombosis.The event is being reported to the us fda as a conservative measure.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.

• 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 ind; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16950732
• MDR Text Key: 315441542
• Report Number: 3008114965-2023-00304
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: ENTERPRISE STENTS.; NEUROFORM (STRYKER).; WALLSTENT (BOSTON SCIENTIFIC).
• Patient Outcome(s): Life Threatening