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 Paresis (1998); Thrombosis/Thrombus (4440)

Event Date 05/03/2007

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed:weber w, bendszus m, kis b, boulanger t, solymosi l, kühne d.A new self-expanding nitinol stent (enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms.Neuroradiology.2007 jul;49(7):555-61.Doi: 10.1007/s00234-007-0232-2.Epub 2007 may 3.Pmid: 17476494.Objective: authors report the results of the european prospective study using the enterprise stent in the treatment of 31 wide-necked aneurysms.Cerenovus devices that were used in this study: enterprise stent non-cerenovus devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified enterprise stent: patient id#: (b)(6) experienced intraprocedural stent (thrombosis) treated with iv administration of reopro and presented 30 days with fluctuation mild (hemiparesis) and angiography demonstrated a vessel narrowing at stent site presumed to be recurrent stent (thrombosis).Patient underwent ipsilateral extra-/intracranial bypass surgery (surgical intervention) and completely recovered afterwards.Patient id#: (b)(6) experienced singular generalized epileptic seizure 3 months after procedure and subsequent mri showed a small acute embolic ischemia in the parietal lobe ipsilateral to the lesion.Patient showed no focal neurological symptoms and further seizures were not evident.This delayed embolic event was presumed to be device-related.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed:weber w, bendszus m, kis b, boulanger t, solymosi l, kühne d.A new self-expanding nitinol stent (enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms.Neuroradiology.2007 jul;49(7):555-61.Doi: 10.1007/s00234-007-0232-2.Epub 2007 may 3.Pmid: 17476494.Patient id#: (b)(6) experienced intraprocedural stent (thrombosis) treated with iv administration of reopro and presented 30 days with fluctuation mild (hemiparesis) and angiography demonstrated a vessel narrowing at stent site presumed to be recurrent stent (thrombosis).Patient underwent ipsilateral extra-/intracranial bypass surgery (surgical intervention) and completely recovered afterwards.Section e.1: initial reporter address line 2: research unit, rheinische kliniken essen, department of psychiatry and psychotherapy.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or 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 both 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.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: 18531691
• MDR Text Key: 333088921
• Report Number: 3008114965-2024-00087
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 01/04/2024
• 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
• Patient Outcome(s): Required Intervention