MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403912

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that the patient presented with left middle cerebral artery (mca) stenosis underwent a vascular stent placement procedure.After balloon dilation, stent implantation was initiated.The complaint stent, a 4 mm x 39 mm enterprise®2 stent (encr403912 / 7469266) was used.It was reported that the distal markers of the stent only partially deployed.The physician removed the stent and the concomitant microcatheter (competitor brand) from the patient¿s anatomy and switched to new devices to complete the procedure.The procedure was prolonged by approximately half an hour.There was no report of any negative patient impact.On 27-apr-2023, additional information was received.The information stated that there were no vessel factors that may have contributed to the incomplete expansion.There was no evidence of obstructed blood flow due to the reported event.The temperature indicator label in the inner pouch was checked and found to be within acceptable criteria.The balloon catheter used was a fullblock¿ balloon guiding catheter (heartcare) and the microcatheter used was a headway® microcatheter (microvention).There was resistance during the advancement of the stent, ¿the distal markers of the stent only deployed partially.¿ there was no allegation of any negative patient impact / patient injury.The physician did not consider the half hour delay in the procedure to be clinically significant.The replacement stent was another 4 mm x 39 mm enterprise®2 stent (encr403912).The replacement microcatheter used to complete the procedure was another headway microcatheter.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.E.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device is not available to be returned for analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7469266.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.Incomplete stent expansion requiring additional intervention are known complications associated with the enterprise vascular reconstruction device and are listed in the instructions for use (ifu) as such.Incomplete expansion could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.Since the alleged incomplete stent expansion required the removal of the already placed microcatheter and the use of a second stent device and catheter to conclude the procedure, the event meets us fda mdr reporting criteria under 21 cfr 803.The file will be re-reviewed if additional information is received at a later date.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 report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.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.

• Brand Name: ENTERPRISE2 4MMX39MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16878077
• MDR Text Key: 314663097
• Report Number: 3008114965-2023-00249
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403912
• Device Lot Number: 7469266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: FULLBLOCK¿ BALLOON GUIDING CATHETER (HEARTCARE); HEADWAY® MICROCATHETER (MICROVENTION)