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

Catalog Number ENCR401600

Device Problem Activation Failure (3270)

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

Event Date 11/07/2023

Event Type  malfunction  

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).Section h3 - 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.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.

Event Description

As reported by the field, during a stent assist coil embolization to the c6 segment of internal carotid artery, an enterprise2 4mmx16mm no tip intracranial stent (encr401600, 8254508) was delivered into an unspecified microcatheter (mc) and placed in the target site.The physician started to release the stent, but distal markers of the stent were converged together.The stent was observed from multiple angles under the ray, but the distal markers were unable to open.After several attempts of withdrawing the stent to release it, the stent markers still failed to open.The doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.Additional information received on 23-nov-2023 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.The incomplete expansion did not result in stent migration or embolization of the stent.There was no blood flow restriction.The procedure was prolonged by 10 minutes with no clinical significance.

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).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a stent assist coil embolization to the c6 segment of internal carotid artery, an enterprise2 4mmx16mm no tip intracranial stent (encr401600, 8254508) was delivered into an unspecified microcatheter (mc) and placed in the target site.The physician started to release the stent, but distal markers of the stent were converged together.The stent was observed from multiple angles under the ray, but the distal markers were unable to open.After several attempts of withdrawing the stent to release it, the stent markers still failed to open.The doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.Additional information received on 23-nov-2023 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.The incomplete expansion did not result in stent migration or embolization of the stent.There was no blood flow restriction.The procedure was prolonged by 10 minutes with no clinical significance.A non-sterile enterprise2 4mmx16mm no tip intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no appearance of damages were found on the delivery system and detached stent component.The device was inspected under a microscope, and some struts of the stent component were found broken, even to this both stent ends were noted to be completely expanded.Also, delamination of the parylene coating was noted.The issue reported regarding the incompletely expanded stent component was confirmed based on the broken struts found.The multiple stent strut fractures, and the delamination of the parylene coating observed suggest that the device was inadvertently subjected to excessive force during manipulation.The struts breakage resulted in the lack of proper opening behavior of the stent.With the limited information available, the root cause of the failure mode observed remains inconclusive; however, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.The stent detachment was not originally documented in the complaint, which detailed that the stent was removed and the microcatheter was not replaced, thus, it is not likely that the stent became detached during its removal from the microcatheter and this condition is not related to the reported failure.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8254508.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent this type of damages from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendation: maintain adequate stent length (approximately 5mm) on each side of the aneurysm neck to ensure appropriate neck coverage.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 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
• 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: 18209124
• MDR Text Key: 329003510
• Report Number: 3008114965-2023-00877
• 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,Followup
• Report Date: 01/16/2024

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 Catalogue Number: ENCR401600
• Device Lot Number: 8254508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 12/28/2023
• Supplement Dates FDA Received: 12/12/2023; 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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