MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

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

Patient Problems Aneurysm (1708); Thrombosis/Thrombus (4440)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: lim yc, song j.Long-term outcomes of ruptured blood blister-like aneurysms with multiple (=2) overlapping stents and coiling: a single-center experience.World neurosurg.2023 jul;175:e950-e958.Doi: 10.1016/j.Wneu.2023.04.047.Epub 2023 apr 17.Pmid: 37075893.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 h.4: the device manufacture date is not known as the device lot number is not available / not reported.Regarding the events of a cerebral thrombosis and aneurysm recanalization; since the events are life threatening with the potential to result in permanent impairment of a body function or permanent damage to a body structure and it required a medical/surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The events are 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.

Event Description

This complaint is from a literature source and the following citation was reviewed: lim yc, song j.Long-term outcomes of ruptured blood blister-like aneurysms with multiple (=2) overlapping stents and coiling: a single-center experience.World neurosurg.2023 jul;175:e950-e958.Doi: 10.1016/j.Wneu.2023.04.047.Epub 2023 apr 17.Pmid: 37075893.Background and purpose: to evaluate the long-term feasibility of multiple overlapping stents (=2) with or without coiling for treating blood blister-like aneurysms (bbas).Bbas treated with stent-assisted coiling or stent-only therapy wasincluded.Bbas with atypical anatomical locations, other endovascular or surgical techniques performed, and delayed treatment (>48 hours) were excluded.Medical records of patients and procedures were retrospectively reviewed.Seventeen patients with bbas were identified, and 15 were treated with stent-assisted coiling and 2 with stent-only therapy.Cerenovus devices that were used in this study: qty unk: enterprise stents non-cerenovus devices that were also used in this study: qty unk: neuroform stents (stryker); lvis stents (microvention terumo); solitaire stents (medtronic) 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:all patients were treated with at least one enterprise stent, therefore aes are associated with device.Qty 1: one patient experienced transient diffuse in-stent fibrin formation.It was resolved with 1 mg intra-arterial tirofiban and resulted in grade 3 right-sided weakness (mrs score, 4) at discharge.Qty 4: anuerysm recurrence.A second surgical intervention was required for the treatment of aneurysm recurrences.

• Brand Name: UNKENTERPRISE2
• 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: 18609595
• MDR Text Key: 334142785
• Report Number: 3008114965-2024-00154
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• 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: LVIS® STENT SYSTEM (MICROVENTION TERUMO); NEUROFORM® STENT SYSTEM (STRYKER); SOLITAIRE® STENT SYSTEM (MEDTRONIC)
• Patient Outcome(s): Required Intervention