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 Thrombosis/Thrombus (4440)

Event Date 12/03/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: jia j, lv x, liu a, wu z, li y.Enterprise stent-assisted coiling of wide-necked intracranial aneurysms: clinical and angiographic follow-up.Interv neuroradiol.2012 dec;18(4):426-31.Doi: 10.1177/159101991201800408.Epub 2012 dec 3.Pmid: 23217637; pmcid: pmc3520556.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 facility name: (b)(6) institute and (b)(6) hospital.Section e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Although no specific intervention is stated, it is clinically reasonable to assume an intervention would be provided in the case of an occlusion at/near the stent site.Each listed event is being reported to the us fda as a conservative measure.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.

Event Description

This complaint is from a literature source and the following citation was reviewed: jia j, lv x, liu a, wu z, li y.Enterprise stent-assisted coiling of wide-necked intracranial aneurysms: clinical and angiographic follow-up.Interv neuroradiol.2012 dec;18(4):426-31.Doi: 10.1177/159101991201800408.Epub 2012 dec 3.Pmid: 23217637; pmcid: pmc3520556.Methods: from april 2009 to october 2011, 604 consecutive patients with a total of 670 cerebral aneurysms underwent endovascular coil em-bolization procedure at our institution.Of these,169 patients (182 wide-necked aneurysms) underwent an attempted sace procedure.A wide-necked aneurysm was defined as having an angiographically measured dome-neck ratio of <1.5 mm or a neck that was =4 mm.Three of the 182 aneurysms were not stented (3/182, 1.6%) due to technical difficulties.Ultimately 166 patients with 179 cerebral aneurysms were treated with the placement of the enterprise stent.Concomitant cerenovus devices that were used in this study: enterprise stents concomitant non-cerenovus devices that were also used in this study: n/a adverse event(s) and provided interventions categorized as procedure-related complications for unknown enterprise stent 62 yo female sah r-pcom 3 mm experienced qty 1 in-stent thrombosis.30 yo male headache basilar trunk 18 mm experienced in-stent thrombosis.59 yo female tia l-ophthalmic 6 mm experienced in-stent thrombosis l- pcom 3 mm.66 yo female cn palsy r-pcom 4 mm experienced in-stent thrombosis l-vertebral 11 mm.40 yo female cn palsy l-ophthalmic 7 mm experienced in-stent thrombosis.71 yo male tia r-pcom 3 mm experienced asymptomatic stenosis.60 yo female headache l-ophthalmic 4 mm experienced aneurysm perforation that resulted in death.

• 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: 16969628
• MDR Text Key: 315657134
• Report Number: 3008114965-2023-00329
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 05/04/2023
• 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: ENTERPRISE STENTS
• Patient Outcome(s): Life Threatening