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 Obstruction/Occlusion (2422)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This complaint is from a literature source.The citation is as follows: delgado f, oteros r, jimenez-gomez e, bravo rey i, bautista md, valverde moyano r.Half bolus dose of intravenous abciximab is safe and effective in the setting of acute stroke endovascular treatment.J neurointerv surg.2019 feb;11(2):147-152.Doi: 10.1136/neurintsurg-2018-014163.Epub 2018 aug 28.Pmid: 30154253.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.The initial reporter contact information is not available.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The citation is as follows: delgado f, oteros r, jimenez-gomez e, bravo rey i, bautista md, valverde moyano r.Half bolus dose of intravenous abciximab is safe and effective in the setting of acute stroke endovascular treatment.J neurointerv surg.2019 feb;11(2):147-152.Doi: 10.1136/neurintsurg-2018-014163.Epub 2018 aug 28.Pmid: 30154253.Objective and methods: the aim of this study was to evaluate the incidence of symptomatic intracerebral hematoma (sich) associated with our antiplatelet protocol.During the study period of january 2015 and march 2018, 373 patients with emerging large vessel occlusion were treated by the endovascular method.Intravenous half bolus dose of abciximab was administered to 99 patients.The need for a stent was determined by a neuroradiologist.An enterprise stent were used for intracranial stenosis and carotid wallstent (boston scientific) for extracranial vessels.When it was necessary to dilate an extracranial vessel in the extracranial setting, a viatrac catheter balloon (abbott) was used to dilate the stent.Stenting of the target lesion was successful in all cases.There were three cases where stenting was not necessary.Lot number is not available, but the suspected cerenovus device possibly associated with reported adverse events: enterprise stent.Concomitant cerenovus devices that were also used in this study: rapid transit microcatheter, concomitant non-cerenovus devices that were also used in this study: 80cm 7f super arrowflex sheath introducer (teleflex); 5 or 6f navien catheter (medtronic); sofia catheter (microvention); trevo microcatheter (stryker); trevo stentriever (stryker); preset stentriever (phenox); carotid wallstent (boston scientific); viatrac balloon catheter (abbott).Adverse event(s) and provided interventions: in four cases of failed rescue stentings after unsuccessful thrombectomy, an acute occlusion of the stent occurred.At the 3-month follow-up, 2 patients (1 middle cerebral artery and 1 intra-and extracranial stents) had an occluded stent.

• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13515807
• MDR Text Key: 290158449
• Report Number: 3008114965-2022-00102
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• 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: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening