MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC402300

Device Problems Break (1069); Premature Activation (1484)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

As reported by the field, on the catheter table, the package of an enterprise2 4mmx23mm no tip intracranial stent ((b)(6)) was opened, and the device pulled from the hoop according to the instructions for use (ifu).When attempted to insert the enterprise 2 into the prowler select plus microcatheter (mc), found that delivery wire was protruded from distal part of introducer and the stent fell off onto the catheter table.The enterprise 2 was not clinically used.Since the same size was not available, replaced with a 4.0 x 16 mm enterprise 2, which was implanted to the lesion and the procedure was successfully completed.The physician¿s comment included that as always, both the introducer and delivery wire were held when pulling the enterprise 2 out of the hoop.Suspected that the stent part had been already slightly protruding from the introducer.A continuous flush was done.

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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.The company is seeking this information through the event investigation.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.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, on the catheter table, the package of an enterprise2 4mmx23mm no tip intracranial stent (enc402300, 8137627) was opened, and the device pulled from the hoop according to the instructions for use (ifu).When attempted to insert the enterprise 2 into the prowler select plus microcatheter (mc), found that delivery wire was protruded from distal part of introducer and the stent fell off onto the catheter table.The enterprise 2 was not clinically used.Since the same size was not available, replaced with a 4.0 x 16 mm enterprise 2, which was implanted to the lesion and the procedure was successfully completed.The physician¿s comment included that as always, both the introducer and delivery wire were held when pulling the enterprise 2 out of the hoop.Suspected that the stent part had been already slightly protruding from the introducer.A continuous flush was done.No additional information is available.A non-sterile 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent was already detached from the unit.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or elongations).Microscopic inspection was performed on the stent component.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, both ends can be noted as completely flared.The delivery wire was subjected to dimensional analysis and all measurements were found to be within specification, including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The customer complaint regarding a stent falling off into the catheter table was confirmed since the stent was noted as already separated from the delivery system.However, the dimensional analysis performed showed no issues that could have resulted in the premature detachment of the stent; additionally, the issue regarding the delivery wire protruding from the introducer was not confirmed since no such conditions were observed during the analysis.With the information available, the root cause of the failure encountered cannot be determined.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the enterprise device.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8137627.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.There is a 100% in-process inspection that requires verification of the marker position and marker band alignment on the stent.The inspection also requires visual verification of the strut integrity of the stent and verification that the stent can move in the introducer.There is also a 100% inspection performed by quality after manufacturing.The 100% quality inspection consists of verification of marker band position on the stent and visual inspection for strut integrity of the stent.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 partially deploy the stent from the introducer.Confirm that the delivery wire does not move relative to the introducer during the removal of the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.Confirm the tip of the delivery wire is entirely within the introducer.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 4MMX23MM 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: 18597231
• MDR Text Key: 334881587
• Report Number: 3008114965-2024-00147
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC402300
• Device Lot Number: 8137627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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: UNKNOWN PROWLER SELECT PLUS.