MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/07/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: mitsuhashi t, oishi h, makino k, tokugawa j, fuse a, hishii m.Stent-assisted coil embolization for acute ruptured dissecting aneurysm at the p2 segment of the posterior cerebral artery: a case report.J neuroendovasc ther.2022;16(3):157-162.Doi: 10.5797/jnet.Cr.2021-0054.Epub 2021 aug 7.Pmid: 37502277; pmcid: pmc10370781.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.

Event Description

This complaint is from a literature source and the following citation was reviewed: mitsuhashi t, oishi h, makino k, tokugawa j, fuse a, hishii m.Stent-assisted coil embolization for acute ruptured dissecting aneurysm at the p2 segment of the posterior cerebral artery: a case report.J neuroendovasc ther.2022;16(3):157-162.Doi: 10.5797/jnet.Cr.2021-0054.Epub 2021 aug 7.Pmid: 37502277; pmcid: pmc10370781.Background and purpose: we report a case of ruptured posterior cerebral artery (pca) dissecting aneurysm treated with stent-assisted coil embolization in the acute phase of ruptured aneurysm.A 60-year-old woman presented with sudden onset of severe headache followed by unconsciousness.Ct showed severe subarachnoid hemorrhage.Digital subtraction angiography showed a dissecting aneurysm at the p2 segment of the right pca.Stent-assisted coil embolization was performed for the ruptured dissecting aneurysm.Since thrombus was observed in the stent, ozagrel was administered intravenously, and the thrombus gradually disappeared during the follow-up period.She was discharged without neurological deficit.Cerenovus devices that were used in this study: qty (b)(4): enterprise stent.Adverse event(s) and provided interventions associated with enterprise stent: qty (b)(4): thrombus formation within stent during procedure, which was treated with intravenous medication.No patient consequence.

• Brand Name: UNKENTERPRISE2
• 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: 18608779
• MDR Text Key: 334141157
• Report Number: 3008114965-2024-00153
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Female