MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403000

Device Problem Activation Failure (3270)

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

Event Date 05/06/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding medical history and race 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, during a stent assist coil embolization for intracranial arterial stenosis and after vascular access was established, an enterprise2 4mmx30mm no tip intracranial stent (encr403000, 7115178) was implanted in the desired place.The physician started to release the stent, it was found that the stent tip was released partially (did not pass though the recapture limit point), but the distal end of the stent did not fully open or expand as intended.The doctor tried to adjust the release position; the stent was still unable to open completely.The physician retracted the stent and switched to 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 the advancement of the device.There was no stent damage.There were no vessel factors that may have contributed to the incomplete expansion (i.E.Tortuosity, calcification, vasospasm).No additional intervention was performed to attempt to expand the stent.No blood flow restriction.There was a 20-minute procedural delay due to the event, however, it was not clinically significant.

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 for intracranial arterial stenosis and after vascular access was established, an enterprise2 4mmx30mm no tip intracranial stent (encr403000, 7115178) was implanted in the desired place.The physician started to release the stent, it was found that the stent tip was released partially (did not pass though the recapture limit point), but the distal end of the stent did not fully open or expand as intended.The doctor tried to adjust the release position; the stent was still unable to open completely.The physician retracted the stent and switched to 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 the advancement of the device.There was no stent damage.There were no vessel factors that may have contributed to the incomplete expansion (i.E.Tortuosity, calcification, vasospasm).No additional intervention was performed to attempt to expand the stent.No blood flow restriction.There was a 20-minute procedural delay due to the event, however, it was not clinically significant.A non-sterile enterprise2 4mmx30mm 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 the tip of the delivery wire was found with kink damages.The proximal end of the proximal coil was found detached from the delivery wire.Three (3) struts of the stent component was found broken, and both stent ends were noted to be completely expanded.Also, delamination of the parylene coating was noted.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.The issue reported regarding the incompletely expanded stent component was confirmed based on the broken struts found.The multiple stent strut fractures, the delamination of the parylene coating, and the damages observed on the delivery wire 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.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 recommendations: ¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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.

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.

• Brand Name: ENTERPRISE2 4MMX30MM 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: 16952777
• MDR Text Key: 315467035
• Report Number: 3008114965-2023-00307
• 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: 06/13/2023

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: ENCR403000
• Device Lot Number: 7115178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/05/2023; 06/12/2023
• Supplement Dates FDA Received: 06/05/2023; 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic