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 Intracranial Hemorrhage (1891); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 12/07/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: xi z, zhibin c, yun l, guangxin d, he z, jingwei l, yun x.Low-dose intravenous tirofiban infusion after endovascular recanalization for non-acute middle cerebral artery occlusion.Heliyon.2022 dec 21;8(12):e12354.Doi: 10.1016/j.Heliyon.2022.E12354.Pmid: 36619459; pmcid: pmc9813718.Objective and methods: this study aims to investigate the safety and effectiveness of tirofiban after elective angioplasty (evt) in 48 patients with non-acute middle cerebral artery (mca) occlusion related ischemic stroke treated between august 2017 and april 2021.Patients who received evt without hemorrhage were divided into 2 groups: those who did not receive intravenous tirofiban treatment (control group, n = 25); those who received a continuous intravenous infusion of 0.2-0.3 mg/h tirofiban for 48 h after endovascular recanalization (intravenous tirofiban group, n = 23).Early reocclusion of treated arteries, symptomatic hemorrhage, and 90-day functional outcome of the 2 groups were compared.All patients received balloon angioplasty (competitor product) and an enterprise stent.Results: the 90-day mrs score and nihss score after endovascular recanalization showed no significantly different between the two groups.However, the rate of mrs score reverse (=1) was significantly higher in the intravenous tirofiban group than the control, and the rate of nihss score reverse (=3) in the intravenous tirofiban group was also higher.The rate of early reocclusion, and symptomatic hemorrhage, showed no difference between the two groups.Conclusions: low-dose intravenous tirofiban infusion after endovascular treatment seems to be safe and potentially effective for non-acute middle cerebral artery occlusion patients.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: sino balloon catheter (sinomed, china).This complaint will capture all adverse events potentially associated with cnv devices.Any adverse events associated with competitors or unknown products or attributed to the patient¿s preexisting conditions will be excluded.Adverse event(s) and provided interventions associated with cerenovus devices: 2 patients in the control group experienced early reocclusions due to stent thrombosis- no treatment specified.One occlusion was secondary to stent release in the vascular dissection and one was secondary to left mca plaques squeezed into aca after balloon dilation.2 patients had asymptomatic postoperative hemorrhage- no treatment was specified as the hemorrhages were reabsorbed after 7 days without patient symptoms.2 patients had postoperative symptomatic (associated with neurological deterioration >3 point increase in nihss) hemorrhage- no treatment specified.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: xi z, zhibin c, yun l, guangxin d, he z, jingwei l, yun x.Low-dose intravenous tirofiban infusion after endovascular recanalization for non-acute middle cerebral artery occlusion.Heliyon.2022 dec 21;8(12):e12354.Doi: 10.1016/j.Heliyon.2022.E12354.Pmid: 36619459; pmcid: pmc9813718.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.

• 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: 16950786
• MDR Text Key: 315438303
• Report Number: 3008114965-2023-00305
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: 05/03/2023
• 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: SINO BALLOON CATHETER (SINOMED, CHINA)
• Patient Outcome(s): Life Threatening