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 Aneurysm (1708); Unspecified Nervous System Problem (4426)

Event Date 08/01/2012

Event Type  Injury  

Event Description

This complaint is from a literature source and the following citation was reviewed: phillips tj, wenderoth jd, phatouros cc, rice h, singh tp, devilliers l, wycoco v, meckel s, mcauliffe w.Safety of the pipeline embolization device in treatment of posterior circulation aneurysms.Ajnr am j neuroradiol.2012 aug;33(7):1225-31.Doi: 10.3174/ajnr.A3166.Epub 2012 jun 7.Pmid: 22678845; pmcid: pmc7965498.Objective: authors assessed the safety of ped placement in the posterior circulation.Cerenovus devices that were used in this study: enterprise stent.Concomitant non-cerenovus devices that were also used in this study: ped.Adverse event(s) and provided interventions possibly associated with unidentified enterprise stent: fig 1.Patient 18 was a 43-year-old man who presented with wfns grade 4 sah.A multilocular vertebrobasilar junction aneurysm at a fenestration was treated with stent-assisted enterprise coiling, with the stent in the left limb of the fenestration.The patient had a stormy course, including symptomatic vasospasm requiring angioplasty, but made an excellent recovery.Follow-up angiography documents a growing aneurysm and some compaction (aneurysm recanalization).Patient received filling of the aneurysm from the right and left sides.A ped was placed within the left vertebrobasilar enterprise stent (surgical intervention), and the endoleak was treated with coil occlusion of the right vertebral artery and a right fenestrated limb.Follow-up angiogram at 12 months documents patency of the construct without aneurysm filling.Article notes he had permanent neurologic deficit of unilateral hamstring tightness (neurological impairment).

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: phillips tj, wenderoth jd, phatouros cc, rice h, singh tp, devilliers l, wycoco v, meckel s, mcauliffe w.Safety of the pipeline embolization device in treatment of posterior circulation aneurysms.Ajnr am j neuroradiol.2012 aug;33(7):1225-31.Doi: 10.3174/ajnr.A3166.Epub 2012 jun 7.Pmid: 22678845; pmcid: pmc7965498.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 h.4: the device manufacture date is not known as the device lot number is not available / not reported.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 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.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: 18531055
• MDR Text Key: 333088863
• Report Number: 3008114965-2024-00086
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PIPELINE¿ EMBOLIZATION DEVICE (MEDTRONIC).
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male