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 Transient Ischemic Attack (2109)

Event Date 12/31/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.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 lot number was provided by the customer.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: 1226348-2021-00061, 3008264254-2021-00010, 3008264254-2021-00011.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 4 patients underwent endovascular treatment unruptured intracranial aneurysms and suffered transient ischemic events.Intervention was not reported.Model and catalog number are not available, but the suspected device is enterprise stent.Other cnv devices that were also used in this study: envoy.Non-cnv devices that were also used in this study: microcatheter (echelon-10), microguidewire (traxcess-14), microplex (microvention), axium (ev3), solitaire stent (ev3), hyperglide balloon, hyperform balloon.Publication details: title: incidence and predictors of headache relief after endovascular treatment in patients with unruptured intracranial aneurysms.Objective: patients with unruptured intracranial aneurysms often present with headaches.We retrospectively determined the incidence of headache relief in patients with unruptured intracranial aneurysms after endovascular treatment, with the main goals of preventing aneurysmal haemorrhage and identifying factors associated with headache relief in a cohort study.Methods: from a cohort of patients with unruptured intracranial aneurysms who were treated with endovascular coiling and admitted between january 2012 and december 2014, we included 123 patients who had headaches and underwent regular follow-up.The severity of headache was assessed by a quantitative 11-point headache scale for all patients before and after the endovascular treatment.Headache relief was defined as a decrease in the headache score.We determined the incidence and predictors of headache relief using kaplanmeier curves and cox regression analysis.

• 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, CA 92618 ; 949789-868
• MDR Report Key: 12547185
• MDR Text Key: 273802211
• Report Number: 1226348-2021-00060
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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: 09/08/2021
• 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
• Treatment: AXIUM (EV3); HYPERFORM BALLOON; HYPERGLIDE BALLOON; MICROCATHETER (ECHELON-10); MICROGUIDEWIRE (TRAXCESS-14); MICROPLEX (MICROVENTION); SOLITAIRE STENT (EV3)
• Patient Outcome(s): Other
• Patient Age: 51 YR