MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No : (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.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.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.Cerenovus manufacturer's report numbers: 1226348-2021-00044, 1226348-2021-00045, 1226348-2021-00046, 1226348-2021-00048, 1226348-2021-00049, 1226348-2021-00050 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent stent-assisted coil embolization of an unruptured intracranial aneurysm and suffered frontal lobe hematoma after 12 days post procedure.Intervention was not reported.Model and catalog number are not available, but the suspected device is enterprise.Other cnv devices that were also used in this study: none non-cnv devices that were also used in this study: solitaire ab, lvis (microvention).Publication details.Title: microbleeds after stent-assisted coil embolization of unruptured intracranial aneurysms: incidence, risk factors and the role of thromboelastography objective: to analyze the incidence and risk factors of microbleeds lesions and to use thromboelastography (teg) to evaluate the relationship between perioperative platelet function and microbleed events in patients with unruptured intracranial aneurysms (uias) undergoing stent-assisted coil (sac) embolization.Methods: we retrospectively enrolled 261 patients with uias undergoing sac embolization between november 2017 and october 2019.All patients received unanimous antiplatelet protocol (aspirin 300 mg and clopidogrel 300 mg).Platelet function was evaluated by teg, and magnetic resonance susceptibility-weighted imaging (swi) was performed for microbleeds detection before and after surgery.Univariate and multivariate logistic regression analyses were used to identify potential risk factors for microbleeds following embolization.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine 92618 ; 949789-868
• MDR Report Key: 12243480
• MDR Text Key: 268211093
• Report Number: 1226348-2021-00047
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2021
• 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): Other
• Patient Age: 54 YR