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 Intracranial Hemorrhage (1891)

Event Date 03/24/2023

Event Type  Death  

Event Description

This complaint is from a literature source and the following citation was reviewed: wu q, meng y, chen a, xu s, wang c, ji z, qi j, yuan k, shao j, shi h, wu p.Lvis-within-enterprise double-stent technique with coil embolization in the treatment of patients with acutely ruptured intracranial vertebrobasilar artery-dissecting aneurysms.Front neurol.2023 mar 24;14:1069380.Doi: 10.3389/fneur.2023.1069380.Pmid: 37034072; pmcid: pmc10081676.Purpose/objective/methods: objective: this study aimed to evaluate the feasibility of the low-profile visualized intraluminal support (lvis)-within-enterprise double-stent technique for patients with acutely ruptured intracranial vertebrobasilar artery-dissecting aneurysms (ari-vbdas).Methods: a total of 30 patients with ari-vbdas who underwent reconstructive treatment using lvis-within-enterprise double-stent technique with coil embolization between january 2014 and may 2022 were retrospectively enrolled.Patients¿ characteristics and clinical and imaging outcomes were reviewed.The functional outcomes were assessed using the modified rankin scale (mrs).Results: a total of 34 ari-vbdas were identified, including seven (20.6%) basilar artery aneurysms and 27 (79.4%) vertebral artery aneurysms.All aneurysms were successfully treated in the acute phase.In total, six (20.0%) patients experienced in-hospital serious adverse events, including two deaths (6.7%).The median clinical follow-up time of the remaining 28 patients was 20.0 (iqr, 7.3¿40.8) months.The incidences of dependency or death (mrs score of 3¿6) at discharge and at the last follow-up were 16.7% and 14.3%, respectively.Aneurysm rebleeding occurred in one (3.3%) patient peri procedurally.In total, three (10.0%) patients had ischemic events, one of which occurred during the periprocedural period and two occurred during follow-up.A total of two patients (6.7%) underwent ventriculoperitoneal shunt.Imaging follow-up was available for 14 patients at the median of 12.0 (iqr, 7.0¿12.3) months, with a complete occlusion rate of 93.3% (14/15).In total, one patient experienced parent artery occlusion, and no aneurysm was recanalized.Conclusion: lvis-within-enterprise double-stent technique with coil embolization for the treatment of patients with ari-vbdas could be performed with a good safety profile and high technical success rate.The rate of complete aneurysm occlusion during follow-up seemed to be satisfactory.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent cerenovus devices that were used in this study: n/a non-cerenovus devices that were also used in this study: lvis stent (micro-vention-terumo) exact product quantities cannot be accurately determined as patients can experience more than one adverse event.Death event(s) possibly associated with unidentified enterprise stent: qty 1 patient with admission of wfns grade of 2 experienced re-bleeding the day after the procedure and subsequently died - another death is reported to be associated with the initial aneurysm rupture and not the procedure or device adverse event(s) and provided interventions possibly associated with unidentified enterprise stent: qty 1 patient experienced unilateral limb weakness 1 day after the procedure and the mrs at discharge was 3 with updated score of 1 at a follow up.Qty 1 patient with the admission wfns grade of 1 developed hydrocephalus and the ventriculoperitoneal shunt was then performed - mrs at discharge was 4 with final mrs of 0 at follow up.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: wu q, meng y, chen a, xu s, wang c, ji z, qi j, yuan k, shao j, shi h, wu p.Lvis-within-enterprise double-stent technique with coil embolization in the treatment of patients with acutely ruptured intracranial vertebrobasilar artery-dissecting aneurysms.Front neurol.2023 mar 24;14:1069380.Doi: 10.3389/fneur.2023.1069380.Pmid: 37034072; pmcid: pmc10081676.Section b.2: date of death: the date of death is not known / documented in the article.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 the event is life threatening and it might result in death, permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The event is reportable to the us fda.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; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17283825
• MDR Text Key: 318640664
• Report Number: 3008114965-2023-00475
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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: 06/22/2023
• 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): Death