MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402300

Device Problems Break (1069); Difficult to Advance (2920); Activation Problem (4042)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization, an enterprise2 4mmx23mm no tip intracranial stent (encr402300, 7126529) and a prowler select plus 150/5cm microcatheter (606s255x, 30952061) were placed in the target position.The physician encountered resistance during the process of delivering the stent.After the stent passed through the microcatheter tip, the doctor tried to release the stent, but the stent could not be released.After 2 attempts, the stent was still unable to release.The physician removed the stent with the microcatheter together and completed the surgery.The stent markers were found to be kinked/bent.The patient suffered from intracranial arterial stenosis.

Manufacturer Narrative

Product complaint #:(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).The device was discarded; therefore, no further investigation can be performed.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of two products involved with the complaint and the associated manufacturer report numbers: 3008114965-2023-00166.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).Complaint conclusion: as reported by the field, during a stent assist coil embolization, an enterprise2 4mmx23mm no tip intracranial stent (encr402300, 7126529) and a prowler select plus 150/5cm microcatheter (606s255x, 30952061) were placed in the target position.The physician encountered resistance during the process of delivering the stent.After the stent passed through the microcatheter tip, the doctor tried to release the stent, but the stent could not be released.After 2 attempts, the stent was still unable to release.The physician removed the stent with the microcatheter together and completed the surgery.The stent markers were found to be kinked/bent.The patient suffered from intracranial arterial stenosis.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.Delivery wire- resistance/friction with loss of mc cerebral target position and unable to deploy stent are known potential complication associated with the use of the enterprise 2 vascular reconstruction device in the intracranial arteries.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Per the instructions for use (ifu), if stent positioning is satisfactory, carefully retract the infusion catheter, while maintaining the position of the delivery wire, to allow the stent to deploy across the neck of the aneurysm.The stent will expand as it exits the infusion catheter.The ifu warns to not deploy the stent if it is not properly positioned in the vessel.Note: if using the microcatheter jailing technique, verify that the position of the infusion catheter delivering the embolic coils has been maintained.If necessary, reposition the infusion catheter using standard endovascular practice.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX23MM 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
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16537434
• MDR Text Key: 311752684
• Report Number: 3008114965-2023-00165
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402300
• Device Lot Number: 7126529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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: PROWLER SELECT PLUS 150/5CM