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 12/01/2009

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.E.1: the initial reporter contact information is not available.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 required medical/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.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Event Description

This complaint is from a literature source and the following citation was reviewed: hong b, patel nv, gounis mj, deleo mj 3rd, linfante i, wojak jc, wakhloo ak.Semi-jailing technique for coil embolization of complex, wide-necked intracranial aneurysms.Neurosurgery.2009 dec;65(6):1131-8; discussion 1138-9.Doi: 10.1227/01.Neu.0000356983.23189.16.Pmid: 19934972.Background and purpose: we describe a modified jailing technique that improves catheter maneuverability and report the safety and efficacy of the method for the treatment of complex, wide necked aneurysms.Twenty-two complex, wide-necked aneurysms, including 3 ruptured and 5 dissecting, were treated using the semi-jailing technique (15 women; mean age, 55.2 years).Cerenovus devices that were used in this study: qty unk: enterprise stents adverse event(s) and provided interventions associated with the enterprise stent: qty 2: cases of thromboembolic events after stent placement.Treatment was intraprocedural thrombolysis.

• 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 ; 3035526892
• MDR Report Key: 18504163
• MDR Text Key: 332790810
• Report Number: 3008114965-2024-00056
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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
• Date Manufacturer Received: 01/03/2024
• 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): Life Threatening; Required Intervention