MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF402312

Device Problem Material Separation (1562)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Initial reporter phone: (b(6).The initial reporter email address is not available / was not reported.[conclusion]: the healthcare professional reported that during a vascular stent placement procedure, when the delivery wire of the 4.0mm dia x 23mm enterprise® 2 stent (enf402312 / 10994287) was being advanced through the y connector of the concomitant microcatheter (unspecified brand), the delivery wire broke.It was fully pulled out of the microcatheter; a new replacement stent was used, and the procedure successfully completed without any delay.It was reported that there was no fragment generated and there was no report of any patient adverse event or complication.Additional information was provided on 17 june 2021, indicated that the delivery wire became separated in two pieces.Factors that may have led to the delivery wire becoming separated into two pieces were not known.Adequate and continuous flush had been maintained through the microcatheter; the concomitant device functioned as expected.Excessive force was not applied to the device.The malfunctioned device was successfully removed from the patient without the need of additional intervention.The concomitant device was not removed; cerebral target position was maintained.The information confirmed that the device did not fragment and there were no fragments remaining in the patient.Follow-up intervention is not required.There was also no issue associated with the device packaging.Based on complaint information, the device was 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 10994287.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 reported in the complaint but without the product available for analysis, the reported issue could not be confirmed through functional evaluation and analysis.It was reported that factors that may have led to the delivery wire becoming separated into two pieces were not known.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, the target size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a vascular stent placement procedure, when the delivery wire of the 4.0mm dia x 23mm enterprise® 2 stent (enf402312 / 10994287) was being advanced through the y connector of the concomitant microcatheter (unspecified brand), the delivery wire broke.It was fully pulled out of the microcatheter; a new replacement stent was used, and the procedure successfully completed without any delay.It was reported that there was no fragment generated and there was no report of any patient adverse event or complication.Additional information was provided on 17 june 2021, indicated that the delivery wire became separated in two pieces.Factors that may have led to the delivery wire becoming separated into two pieces were not known.Adequate and continuous flush had been maintained through the microcatheter; the concomitant device functioned as expected.Excessive force was not applied to the device.The malfunctioned device was successfully removed from the patient without the need of additional intervention.The concomitant device was not removed; cerebral target position was maintained.The information confirmed that the device did not fragment and there were no fragments remaining in the patient.Follow-up intervention is not required.There was also no issue associated with the device packaging.

• Brand Name: ENTERPRISE2 4MMX23MM
• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12069857
• MDR Text Key: 258487092
• Report Number: 3008114965-2021-00250
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: 10886704075356
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

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 Expiration Date: 03/28/2021
• Device Model Number: ENF402312
• Device Catalogue Number: ENF402312
• Device Lot Number: 10994287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• 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