MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403912

Device Problem Failure to Advance (2524)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00390 and 3008114965-2024-00391.

Event Description

As reported by the field, during an endovascular embolization to the middle cerebral artery, an enterprise2 4mmx39mm intracranial stent ((b)(6)) became impeded at the distal end of a prowler select plus 150/5cm microcatheter ((b)(6) lot unknown) and could not pass through the microcatheter (mc).The physician retracted the stent and switched a new stent, an enterprise2 4mmx39mm ((b)(6)) to be delivered with the same microcatheter.The second stent had the same issue.The physician removed the stent and microcatheter from the patient.The physician replaced a new stent and a new microcatheter (non- j&j products) to complete the procedure.The surgery was prolonged about 10 minutes.Additional event information received on (b)(6) 2024 indicated that the mc did not kink or bent.There was vessel tortuosity.The 10-minute procedural delay was not clinically significant.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization to the middle cerebral artery, an enterprise2 4mmx39mm intracranial stent (encr403912, 8314217) became impeded at the distal end of a prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not pass through the microcatheter (mc).The physician retracted the stent and switched to a new stent, an enterprise2 4mmx39mm (encr403912, 8314217) to be delivered with the same microcatheter.The second stent had the same issue.The physician removed the stent and microcatheter from the patient.The physician replaced a new stent and a new microcatheter (non- j&j products) to complete the procedure.The surgery was prolonged about 10 minutes.Additional event information received on (b)(6)2024 indicated that the mc did not kink or bent.There was vessel tortuosity.The 10 minute procedural delay was no clinically significant.A non-sterile enterprise2 4mmx39mm stent was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent component was returned inside the introducer tube.Microscopic inspection revealed that the delivery wire was broken.No damages were noted in the stent.The introducer was found to be undamaged (i.E., no kinks, bents o elongations).Residues of dried saline solution were found inside the introducer.The issue reported regarding a stent being impeded at the distal end of the microcatheter could not be evaluated through a functional test; the broken condition of the delivery wire prevents the ability to move forward the delivery system and perform the proper functional analysis.The broken condition on the delivery wire could be the result of the enterprise system being retracted from the microcatheter with excessive force applied and this is not considered related to the reported issue.It is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.However, with the limited information available, the root cause remains speculative, and the customer complaint cannot be evaluated.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8314217.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 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.

• Brand Name: ENTERPRISE2 4MMX39MM
• 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: 19088599
• MDR Text Key: 340697289
• Report Number: 3008114965-2024-00390
• 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: 05/02/2024

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: ENCR403912
• Device Lot Number: 8314217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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