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

Catalog Number UNK-CNV ENTERPRISE SES

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Date of event: the date of the event/study is not known.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Information such as initial reporter facility name, address, city, state, name, phone and email address are not available / reported.The device manufacture date is not known as the product lot number of the device is not available / not reported.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00009, 1226348-2021-00010, and 1226348-2021-00011.Complaint conclusion: it was reported through the database related research activities (drra) report source on behalf of md-epidemiology, via study report ¿real-world comparison of outcomes among patients with unruptured intracranial aneurysm (uia) undergoing endovascular treatment using the enterprise stent versus the neuroform or low-profile visualized intraluminal support (lvis) stent¿.Five (5) patients underwent an endovascular treatment procedure for an unruptured intracranial aneurysm with the enterprise stent (unknown product code/unknown lot #) vascular reconstruction device and experienced other complications (surgical complication or ventriculostomy or ventriculoperitoneal shunt surgery, or tracheostomy) during the admission period.Based on complaint information, the devices are not available to be returned for analysis.The device lot numbers were not available.The manufacturing documentation reviews could not be performed without the lot number.Product analysis cannot be conducted as the products were not returned for analysis.In addition, there was no report of malfunction associated with the devices.These conditions can cause permanent damage/death or may require or required medical intervention to prevent permanent damage/death.With extremely limited information available, the cause of the complications that the patients experienced are not known.There was no information on patient medical history, and no information on the device and its performance during use in the study procedure and no information related to concomitant devices used during the procedure.The device catalog and lot numbers are not known; therefore, the determination of possible device-related causes cannot be determined through device analysis or through device history record review.The exact cause of the event could not be conclusively determined.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported through the database related research activities (drra) report source on behalf of md-epidemiology, via study report ¿real-world comparison of outcomes among patients with unruptured intracranial aneurysm (uia) undergoing endovascular treatment using the enterprise stent versus the neuroform or low-profile visualized intraluminal support (lvis) stent¿.Five (5) patients underwent an endovascular treatment procedure for an unruptured intracranial aneurysm with the enterprise stent (unknown product code/unknown lot #) vascular reconstruction device and experienced other complications (surgical complication or ventriculostomy or ventriculoperitoneal shunt surgery, or tracheostomy) during the admission period.

• 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11372238
• MDR Text Key: 241429709
• Report Number: 1226348-2021-00012
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CNV ENTERPRISE SES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• 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): Required Intervention