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 Embolism/Embolus (4438)

Event Date 09/01/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: reddy, v.V., shehadeh, k., devasenapathy, a., houran, a., chou, j., & lodi, y.M.(2014).Safety, feasibility and clinical outcome of patients who underwent enterprise stent assisted repair of intracranial aneurysm using loading dose of aspirin and clopidogrel -a single center experience.Neurocritical care, 21, 255¿255.Https://doi.Org/doi 10.1007/s12028-014-0034-4.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.Since this event required medical intervention or prolonged hospitalization for treatment or prevention of permanent damage to the patient, 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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: reddy, v.V., shehadeh, k., devasenapathy, a., houran, a., chou, j., & lodi, y.M.(2014).Safety, feasibility and clinical outcome of patients who underwent enterprise stent assisted repair of intracranial aneurysm using loading dose of aspirin and clopidogrel -a single center experience.Neurocritical care, 21, 255¿255.Https://doi.Org/doi 10.1007/s12028-014-0034-4.Objective and methods: the objective of this study was to determine the safety, feasibility, and clinical outcome of patients who underwent enterprise stent-assisted repair of intracranial aneurysm using acute loading doses of aspirin and clopidogrel.Lot, model, and catalog number are not available, but the suspected cerenovus device is 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: n/a.Adverse event(s) and provided interventions associated with cerenovus devices: a small left subarachnoid hemorrhage was observed in one with a right middle cerebral artery aneurysm (mca).Intra-operative asymptomatic mca branch occlusion developed in one (1) patient and mca was recanalized using intraarterial eptifibatide.Post-operative thromboembolic events were observed in two (2) cases (4%); the first event developed on day two (2) with nihss 6 in a 42 years old woman with a giant right ica giant aneurysm who recovered completely (nihss 0, mrs 0) in 90 days.The second event was visual distortion developed on day two (2) in a 66 years old woman with a basilar artery aneurysm.Her symptoms resolved completely.

• 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.; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16957972
• MDR Text Key: 315528405
• Report Number: 3008114965-2023-00312
• 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: Other
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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
• Date Manufacturer Received: 05/04/2023
• 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
• Patient Outcome(s): Life Threatening