MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISEENF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 10/25/2023

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.E.1: the initial reporter contact information is not available.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 procedure related stroke.The type of stroke is not specified and being coded as an ischemic stroke.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.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.The literature article cannot be attached to due electronic file size.

Event Description

Hold for rw 1.29 this complaint is from a literature source and the following citation was reviewed: zhou m, wu z, maalim aa, zeng y, guo x, zhang z, yuan x, enos zm, shu k, lei t, zhu m.Overlapping stent treatment for ruptured dissecting aneurysms in posterior circulation.Brain sci.2023 oct 25;13 (11):1507.Doi: 10.3390 brainsci13111507.Pmid: (b)(6), (b)(6).Background and purpose: ruptured dissecting aneurysms in posterior intracranial circulation present significant clinical challenges and often cause poor prognoses.Our cohort used overlapping stents as the primary treatment.We analyzed the medical records of 27 patients (18 men/nine women) with ruptured posterior circulation dissecting aneurysms (pcdas).Their average age was 52 years.We selected 11 patients who used enterprise (ep) and lvis stents overlappingly and matched them 1:1 with counterparts who received either ep or lvis stents individually.Overlapping stents was a feasible treatment in all 27 cases.We successfully followed up 26 patients for 6 months.Cerenovus devices that were used in this study: qty unk: enterprise stents.Non-cerenovus devices that were also used in this study: qty unk: detachable coils (microvention); detachable coils (stryker); lvis stents (microvention); ; leo or leo¿s baby stents (balt); neuroform ez stents (stryker); altas stents (stryker).The article provides insufficient information to associate adverse event(s) to specific device manufacturer.Exact product quantities cannot be accurately determined as patients can experience more than one adverse event.Adverse event(s) and provided interventions not identified to be associated with specific device manufacturer's device: the following complications were treated with at least one enterprise stent (stents were implanted using overlapping technique) therefore, the events would be associated with the enterprise stent: qty 2: symptomatic procedure-related stroke.Treatments not listed.(other complications noted were related to baseline condition deterioration and were not included: cerebral edema, continued intracranial hypertension post-procedure which resulted in hospice care death, and hydrocephalus).

• 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: 18595241
• MDR Text Key: 333964097
• Report Number: 3008114965-2024-00145
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• 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: ATLAS® STENT (STRYKER).; DETACHABLE COILS (MICROVENTION).; DETACHABLE COILS (STRYKER).; HEADWAY® 17 MICROCATHETER (MICROVENTION).; LEO BABY® STENT (BALT EXTRUSION).; LEO® STENT (BALT EXTRUSION).; LVIS¿ STENT (MICROVENTION).; NEUROFORM EZ® STENT SYSTEM (STRYKER).
• Patient Outcome(s): Life Threatening