MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

Device Problem Malposition of Device (2616)

Patient Problem Ischemia Stroke (4418)

Event Date 04/18/2011

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed:akgul e, aksungur e, balli t, onan b, yilmaz dm, bicakci s, erman t.Y-stent-assisted coil embolization of wide-neck intracranial aneurysms.A single center experience.Interv neuroradiol.2011 mar;17(1):36-48.Doi: 10.1177/159101991101700107.Epub 2011 apr 18.Pmid: 21561557; pmcid: pmc3278021.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: initial reporter phone: (b)(6) section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Since the event resulted in permanent impairment of a body function or permanent damage to a body structure; it is to be considered serious.The event is 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.

Event Description

This complaint is from a literature source and the following citation was reviewed:akgul e, aksungur e, balli t, onan b, yilmaz dm, bicakci s, erman t.Y-stent-assisted coil embolization of wide-neck intracranial aneurysms.A single center experience.Interv neuroradiol.2011 mar;17(1):36-48.Doi: 10.1177/159101991101700107.Epub 2011 apr 18.Pmid: 21561557; pmcid: pmc3278021.Object/methods: this report evaluated the short and midterm results of the safety and effectiveness of the treatment technique with hybrid and non-hybrid y-configured, dual stent-assisted coil embolization of wide-neck intracranial aneurysms, and reviewed the literature concerning this technique.Nine patients, eight with unruptured and one with ruptured aneurysms were included in the study.Of aneurysms embolized with a hybrid (with two different stents) and non-hybrid (with two identical stents) technique, three were located in the anterior communicating artery, three at the tip and one at the distal site of basilar artery, and two in the middle cerebral artery.All aneurysms included the orifices of bifurcation vessels.All aneurysms were stented and embolized during the same session.While neuroform and enterprise stents were used in the hybrid technique, two enterprise stents were used in the non-hybrid technique.Dual y-stent assisted coil embolization was performed successfully in eight of nine patients (88.9%), including five patients (55.6%) with hybrid and three patients (33.3%) with nonhybrid technique.No procedural complication, no mortality and no minor or major neurological complications were seen during the angiographic or clinical follow-up.When an attempt was made at passing the second stent through the first enterprise stent, the stent protruded inside the aneurysm in one patient (11.1%).Figure 2 a-g caption provides details of the event: the patient with the left middle cerebral artery (mca) aneurysm (patient no.1) had been operated on 2 months previously and could not be clipped: digital subtraction angiography shows the wide-neck mca aneurysm (a).The first enterprise stent (neuroform3 stent could not be placed) lies between the inferior truncus and the proximal part of the mca (black arrows in b).While trying to cross the first stent to deploy the second stent (enterprise), the first stent protruded into the aneurysm, so proximal and distal markers of the first stent migrated (black arrows show the first and white arrows show the second stent markers in c).Aneurysm was intentionally not packed fully due to the protrusion of the stent into the aneurysm (d).This patient stopped taking the antiaggregant drugs (aspirin and clopidogrel) after 2 months and applied to the hospital because of severe headache and speaking problems.The cranial computed tomography showed acute temporal lobe infarction on the left (not shown).The occlusion of the inferior truncus of the left mca was seen on angiography (e).Residual filling was also seen in the neck of the aneurysm.On dsa performed in the 11th month (f), the aneurysm was totally closed and there was no restenosis in the stent lying between the proximal part and the superior truncus of the mca.Magnetic resonance imaging with the flair sequence showed gliotic and cystic changes consistent with chronic infarction of the left temporal and occipital lobes (g) due to the occlusion of the inferior trunk of the mca.Cerenovus devices that were used in this study: enterprise stent non-cerenovus devices that were also used in this study: neuroform 3 stent (boston scientific) adverse event(s) and provided interventions possibly associated with unidentified enterprise stent: patient #1 - 48 yo female with a left mca aneurysm 6x7mm experienced stent protrusion (migration) and acute temporal lobe infarction (cerebral infarction).It is noted by the article this patient had stopped taking anti-aggregate drugs - aspirin and clopidogrel - after two months and then presented at the hospital with symptoms that led to discovery of the cerebral infarction.Antiaggregant treatment was restarted and patient was discharged with minimal emotional symptoms and right hemianopsia.

• 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: 18522195
• MDR Text Key: 332974890
• Report Number: 3008114965-2024-00070
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Treatment: NEUROFORM (BOSTON SCIENTIFIC)
• Patient Outcome(s): Life Threatening