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

Catalog Number ENCR402312

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 01/07/2022

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist embolization of a left posterior communicating artery aneurysm, an enterprise2 4mmx23mm intracranial neurovascular stent (encr402312, 6358010) became impeded in y connector and there was device damage.It was reported that during the procedure, the user pushed the stent to y connector, the delivery wire was impeded in y connector.Then, the physician retracted the stent and observed the tip of the delivery wire was broken, a new stent was used to complete the surgery.There was no patient injury report.Additional information received indicated that a prowler select plus (606s255x, 30416610) was used.A synchro-14 guidewire had been successfully used with the microcatheter prior to the encountered resistance.It was not necessary to remove the microcatheter.There microcatheter did not become damaged during manipulation of the device or was noticed to be damaged upon removal from the patient.It was further clarified that the delivery wire tip separated.A continuous flush was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force was applied to the device.

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 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.

Manufacturer Narrative

(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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a stent assist embolization of a left posterior communicating artery aneurysm, an enterprise2 4mmx23mm intracranial neurovascular stent (encr402312, 6358010) became impeded in y connector and there was device damage.It was reported that during the procedure, the user pushed the stent to y connector, the delivery wire was impeded in y connector.Then, the physician retracted the stent and observed the tip of the delivery wire was broken, a new stent was used to complete the surgery.There was no patient injury report.Additional information received indicated that a prowler select plus (606s255x, 30416610) was used.A synchro-14 guidewire had been successfully used with the microcatheter prior to the encountered resistance.It was not necessary to remove the microcatheter.There microcatheter did not become damaged during manipulation of the device or was noticed to be damaged upon removal from the patient.It was further clarified that the delivery wire tip separated.A continuous flush was maintained.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force was applied to the device.A non-sterile unit enterprise2 4mmx23mm was received inside of a pouch.It was noted that only the stent and delivery wire were returned for evaluation.The stent was inspected, and it was found to be deployed in good normal conditions.On the other hand, it was noted that distal portion of delivery wire was missing.Introducer was not returned for analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6358010.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The device was returned to cerenovus for further evaluation.Visual inspection of the returned enterprise2 4mmx23mm revealed that only the stent and the delivery wire were returned for analysis.Introducer was not returned for analysis.The stent was inspected and found to be deployed and in good normal conditions.On the other hand, it was noted that delivery wire was missing its distal portion.Customer complaint regarding the separation of the delivery wire was confirmed due to the findings observed.Intraprocedural factors may have contributed to the findings, however it can not be determined if these were secondary or contributing factors to the impeded issue reported.The customer complaint as related to the stent being impeded on the microcatheter could not be confirmed since the failure could not be duplicated due to the conditions in which the stent was returned.Additionally, the concomitant microcatheter was not returned for evaluation and no further evidence could be obtained.The event description and device analysis do not provide clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.A device history review was made, and it indicates this product was final inspection tested and was determined to be acceptable.Impeded with no loss of cerebral target position and fractured-separated are potential product failures associated with the use of the device.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following precautions: do not partially deploy the stent from the introducer.Confirm that the delivery wire does not move relative to the introducer during removal of the codman enterprise 2 vascular reconstruction device from the dispenser hoop.Confirm that the tip of the delivery wire is entirely within the introducer.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.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.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13470963
• MDR Text Key: 295144867
• Report Number: 3008114965-2022-00079
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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: 6358010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: No
• 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; SYNCHRO-14 GUIDEWIRE