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

Catalog Number ENCR402312

Device Problem Activation Failure (3270)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

As reported by the field, during a stent-assisted aneurysm embolization, the positioning of an enterprise2 4mmx23mm intracranial stent (encr402312, 7591257) was ¿inaccurate¿, and the stent was retracted to an unspecified microcatheter (mc) twice for adjusting.Then, the physician started to release the stent, it was found that 2 markers of the stent tip were converged which could not expand.Physician observed the stent from multiple angles under the ray, and the 2 markers were still unable to open.Doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.The patient is currently stable.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.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.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 temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no resistance during advancement of the device.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.The prolongation of the procedure by 30 minutes was not clinically significant.The concomitant devices functioned as expected.Complaint conclusion: as reported by the field, during a stent-assisted aneurysm embolization, the positioning of an enterprise2 4mmx23mm intracranial stent (encr402312, 7591257) was ¿inaccurate¿, and the stent was retracted to an unspecified microcatheter (mc) twice for adjusting.Then, the physician started to release the stent, it was found that 2 markers of the stent tip were converged which could not expand.Physician observed the stent from multiple angles under the ray, and the 2 markers were still unable to open.Doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.The patient is currently stable.Additional information received indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no resistance during advancement of the device.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.The prolongation of the procedure by 30 minutes was not clinically significant.The concomitant devices functioned as expected.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 is a known potential procedural complication 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.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 event was 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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17107163
• MDR Text Key: 317775358
• Report Number: 3008114965-2023-00376
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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: 7591257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MICROCATHETER