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

Catalog Number UNKENTERPRISEENC

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

Patient Problems Death (1802); Thromboembolism (2654); No Code Available (3191)

Event Date 01/31/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Aneurysm rupture.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.This is one of six products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2019-00959, 1226348-2019-00960, 1226348-2019-00961, 1226348-2019-00962, 1226348-2019-00963, and 1226348-2019-00964.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿stent assisted coil embolization of anterior communicating artery aneurysms: safety, effectiveness, and risk factors for procedural complications or recanalization¿, 2 patients with anterior communicating artery aneurysm who underwent stent assisted coil embolization with enterprise stent died due to ruptured aneurysms and thromboembolic complications.This study was undertaken to assess the safety and effectiveness of sac embolization in treating acoa aneurysms and to determine risk factors for related procedural complications or recanalization.Methods between august 2008 and december 2016, 184 patients with acoa aneurysms were treated with sac embolization.Cumulative medical record and radiologic data were analyzed using binary logistic regression to identify factors predisposing to procedural complications or recanalization.

Manufacturer Narrative

This is a correction of the previous submission report related to the literature article entitled ¿stent assisted coil embolization of anterior communicating artery aneurysms: safety, effectiveness, and risk factors for procedural complications or recanalization".The product code was updated from unkenterpriseenc to unkenterpriseenf.

• 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): SEE H10; circuito interior norte #1820; juarez chihuahua ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8814368
• MDR Text Key: 151836085
• Report Number: 1226348-2019-00961
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR