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 08/08/2016

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: al kasab s, almadidy z, spiotta am, turk as, chaudry mi, hungerford jp, turner rd 4th.Endovascular treatment for ais with underlying icad.J neurointerv surg.2017 oct;9(10):948-951.Doi: 10.1136/neurintsurg-2016-012529.Epub 2016 aug 8.Pmid: 27502403.Date of death: the date of death is not known / documented in the article.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 phone 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.The enterprise vascular reconstruction device (vrd) is intended for use with occlusive devices in the treatment of intracranial aneurysms.It is not intended for use as a stand-alone device, i.E., without subsequent coil embolization of the aneurysm.This stent was used off-label for the treatment of acute large vessel occlusion (acute ischemic stroke).There is no indication that the enterprise malfunctioned or that the event is related to the device design or manufacturing process.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The citation is as follows: al kasab s, almadidy z, spiotta am, turk as, chaudry mi, hungerford jp, turner rd 4th.Endovascular treatment for ais with underlying icad.J neurointerv surg.2017 oct;9(10):948-951.Doi: 10.1136/neurintsurg-2016-012529.Epub 2016 aug 8.Pmid: 27502403.Objective and methods: the purpose of this study was to evaluate whether procedural complications, revascularization rates, and functional outcomes differ among patients with acute large vessel occlusion (lvo) from intracranialatherosclerotic disease (icad) or thromboembolism.A retrospective review of thrombectomy cases from 2008 to 2015 was carried out for cases of ais due to underlying icad.Thirty-six patients were identified.A chart and imaging review was performed to determine revascularization rates, periprocedural complications, and functional outcomes.Patients with icad and acute lvo were compared with those with underlying thromboemboli.The wingspan stent (stryker) was used in all but two cases where precise and enterprise stents were used.Lot, model and catalog number are not available, but the suspected cerenovus device 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: wingspan stent (stryker), precise stent (cordis).There is insufficient information within the text of this article to identify which devices (s) (cerenovus or non-cerenovus) are associated with the reported complications.Exact quantities cannot be determined accurately as the article does not provide adequate information.Adverse event(s) and provided interventions: four patients had postprocedural ph2 intracerebral hemorrhage (ich), three of whom died during their hospitalization.Significant ich was defined as ph2 with ct-based classification of the european cooperative acute stroke study.

• 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 ; 949789-868
• MDR Report Key: 12972497
• MDR Text Key: 282030231
• Report Number: 3008114965-2021-00653
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• 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: 11/26/2021
• 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: PRECISE STENT (CORDIS); WINGSPAN STENT (STRYKER)
• Patient Outcome(s): Death