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 Aneurysm (1708); Stroke/CVA (1770); Restenosis (4576)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).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.H.4: 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Event Description

This complaint is from a literature source and the following citation was reviewed: mokin m, primiani ct, ren z, piper k, fiorella dj, rai at, orlov k, kislitsin d, gorbatykh a, mocco j, de leacy r, lee j, vargas machaj j, turner r, chaudry i, turk as.Stent-assisted coiling of cerebral aneurysms: multi-center analysis of radiographic and clinical outcomes in 659 patients.J neurointerv surg.2020 mar;12(3):289-297.Doi: 10.1136/neurintsurg-2019-015182.Epub 2019 sep 17.Pmid: 31530655.Background and purpose: this study compared the outcomes of endovascular coiling of cerebral aneurysms using neuroform (neu), enterprise (ep), and low-profile visualized intraluminal support (lvis) stents.Patient characteristics, treatment details and angiographic results using the raymond¿roy grade scale (rrgs), and procedural complications were analyzed in our study.Exact product quantities cannot be accurately determined as patients can experience more than one adverse event.Cerenovus devices that were used in this study: qty unk: (one patient can have more than one aneurysm/stent) enterprise stents (ep; codman & shurtleff, raynham, massachusetts, usa) non-cerenovus devices that were also used in this study: qty unk: (one patient can have more than one aneurysm/stent) neuroform stents (neu; stryker, kalamazoo, michigan, usa); low-profile visualized intraluminal support stents (lvis/lvis jr; microvention, tustin, california, usa).Adverse event(s) and provided interventions: for the enterprise stent unruptured aneurysm group: (procedure related complication)- qty 1: one patient experienced aneurysm rupture during the procedure.(post-procedure complications)- qty 7: seven patients experienced aneurysm recurrence.Qty 5: five patients experienced stroke.Qty 3: three patients experienced in-stent stenosis.Qty 1: one patient experienced recurrent stroke.For the enterprise stent ruptured aneurysm group: (procedure related complication)- qty 2: two patients experienced stent thrombosis during the procedure.(post-procedure complications)- qty 1: one patient experienced aneurysm recurrence.Qty 1: one patient experienced stroke.Treatments not listed.

• 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 ; 3035526892
• MDR Report Key: 18093161
• MDR Text Key: 327642129
• Report Number: 3008114965-2023-00817
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: 10/24/2023
• 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: LVIS/LVIS JR (MICROVENTION); NEUROFORM STENTS (NEU, STRYKER)
• Patient Outcome(s): Life Threatening