MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF401600

Device Problem Difficult to Advance (2920)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2021-00030.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, the tip of an enterprise2 4mmx16mm no tip (enf401600, 11058018) was too stiff.The physician felt strong resistance during the advancement of the enterprise through the distal part of the prowler select plus microcatheter (product/lot number unknown).Finally, the physician changed same-like product, and the procedure was done well.It was noted that the patient¿s pressure was too low, therefore, it was mandatory to end the procedure fast.

Manufacturer Narrative

Product complaint #: (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, the tip of an enterprise2 4mmx16mm no tip (enf401600, 11058018) was too stiff.The physician felt strong resistance during the advancement of the enterprise through the distal part of the prowler select plus microcatheter (product/lot number unknown).Finally, the physician changed to a same-like product, and the procedure was done well.It was noted that the patient¿s pressure was too low, therefore, it was mandatory to end the procedure fast.No additional information is available.A non-sterile unit enterprise2 4mmx16mm no tip was received at cerenovus inside of a pouch for evalaution.The device was inspected, and it was found in good normal conditions, the stent was attached to the delivery wire inside the introducer, no damages or anomalies were observed on it.A lab sample microcatheter was flushed using a lab sample syringe and after that, the received enterprise2 4mmx16mm no tip was introduced into the lab sample microcatheter and it was advance inside it, no resistance/friction was felt during the advancement.Also, no problem was observed during the deployment process.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11058018.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.A visual inspection and functional testing were conducted on the returned device.The visual analysis of the returned sample revealed that the device was returned in good normal conditions, the stent was attached to the delivery wire inside the introducer, no damages or anomalies were observed on it.Based on these finding the customer complaint was not confirmed.The functional test was performed, a lab sample microcatheter was flushed using a lab sample syringe and after that, the received enterprise2 4mmx16mm no tip was introduced into the lab sample micro-catheter and it was advance inside it, no resistance/friction was felt during the advancement.Also, no problem was observed during the deployment process.Since the functional test was performed without a problem, the customer complaint was not confirmed.A device history review was performed, and no non-conformances were identified.The event described could not be confirmed as the analysis of the device was performed without any difficulties and not damages or anomalies were observed on it.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event, the instructions for use (ifu) contain the following directions for use: ¿ remove the delivery wire from the clip on the dispenser hoop.Grasp the proximal end of the introducer and the delivery wire at the point where it exits the introducer.Hold the delivery wire and introducer together to prevent stent movement.Remove the codman enterprise 2 vascular reconstruction device from the dispenser hoop.Do not partially deploy the stent from the introducer.Confirm that the delivery wire does not move relative to the introducer during removal of the codman enterprise 2 vascular reconstruction device from the dispenser hoop.Confirm that the tip of the delivery wire is entirely within the introducer.Confirm that the delivery wire is not kinked, and that the introducer tip is not damaged.Do not continue if either defect is observed; return the device to codman neuro.Do not shape the tip of the delivery wire if a 12 mm tip configuration is selected.This could lead to damage or separation of delivery wire.Do not deploy the stent if it is not properly positioned in the vessel.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: ENTERPRISE2 4MMX16MM NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11876426
• MDR Text Key: 252409079
• Report Number: 3008114965-2021-00216
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: 10886704075349
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

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: 08/28/2021
• Device Model Number: ENF401600
• Device Catalogue Number: ENF401600
• Device Lot Number: 11058018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 06/17/2021; 07/14/2021
• Supplement Dates FDA Received: 07/06/2021; 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKPROWLERSELECTLPES; UNKPROWLERSELECTLPES