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

Catalog Number ENCR402312

Device Problems Failure to Advance (2524); Activation Failure (3270)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization, the physician encountered some resistance when an enterprise2 4mmx23mm intracranial stent (encr402312, 7212914) passed through the tip of an unspecified microcatheter (mc), and the distal end of the stent could not be opened.The stent was removed from the patient¿s body.The doctor tried to deliver the stent again, but it was impeded in the introducer sheath and could not be pushed out.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.

Manufacturer Narrative

Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).Device manufacture date: not available at the time of reporting.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.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).Section b5: additional information received indicated that the brand of the mc is unknown.They were not able to move the device at all due to the resistance.They were not able to torque the device.There was no evidence of physical material within the device.No other devices were used successfully with the concomitant device prior to the encountered resistance.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.There was no blood flow restriction.There were no procedural delays due to the event.Complaint conclusion: as reported by the field, during a stent assist coil embolization, the physician encountered some resistance when an enterprise2 4mmx23mm intracranial stent (encr402312, 7212914) passed through the tip of an unspecified microcatheter (mc), and the distal end of the stent could not be opened.The stent was removed from the patient¿s body.The doctor tried to deliver the stent again, but it was impeded in the introducer sheath and could not be pushed out.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional information received indicated that the brand of the mc is unknown.They were not able to move the device at all due to the resistance.They were not able to torque the device.There was no evidence of physical material within the device.No other devices were used successfully with the concomitant device prior to the encountered resistance.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.There no blood flow restriction.There were no procedural delays due to the event.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.Incomplete stent expansion and delivery wire impeded in introducer are known potential procedural complications associated with the enterprise 2 vrd.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.The instructions for use (ifu) instructs to advance the delivery wire to transfer the stent from the introducer into the infusion catheter.Warns that the delivery wire should not be torqued to gain access into the aneurysm.Continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.Warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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
• 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: 16495090
• MDR Text Key: 311300025
• Report Number: 3008114965-2023-00151
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 7212914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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: UNSPECIFIED MICROCATHETER.