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

Catalog Number UNKENTERPRISEENF

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

Patient Problem Infarction, Cerebral (1771)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (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 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.[conclusion]: it was reported through the database research activities, the real world comparison of outcomes among patients with unruptured intracranial aneurysm (uia) undergoing endovascular treatment using the enterprise stent versus neuroform or low-profile visualized intraluminal support (lvis) stent, there were 26 who were considered to have ischemic complication if they had the relevant international classification of diseases (icd)-9/10 codes listed during the admission period for aphasia, hemiplegia or paraplegia, or cerebral artery occlusion.No other information is available.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.With very limited information, the cause of the ischemic complication in the 26 patients is 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.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.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2019-01040, 1226348-2019-01041, 1226348-2019-01042, and 1226348-2019-01043.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported through the database research activities, the real world comparison of outcomes among patients with unruptured intracranial aneurysm (uia) undergoing endovascular treatment using the enterprise stent versus neuroform or low-profile visualized intraluminal support (lvis) stent, there were 26 who were considered to have ischemic complication if they had the relevant international classification of diseases (icd)-9/10 codes listed during the admission period for aphasia, hemiplegia or paraplegia, or cerebral artery occlusion.No other information is available.

• 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: 9506254
• MDR Text Key: 188804679
• Report Number: 1226348-2019-01041
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• 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