MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X28MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452812

Device Problems Failure to Advance (2524); Activation Failure (3270)

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

Event Date 11/03/2023

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.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.

Event Description

As reported by the field, during the use of an eu 4.5x28mm intracranial stent 12 mm dw tip ((b)(6)), the physician started to release stent after it was placed in target site.The distal markers of the stent did not fully open or expand as intended.It was withdrawn to deliver it again, but the stent was impeded in proximal of unspecified microcatheter (mc) and could not advance any more.Doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.

Manufacturer Narrative

Product complaint (b)(4).Section b5: additional information received on 21-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 prior to the incomplete expansion.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion.There was no additional intervention performed to attempt to expand the stent.There was no blood flow restriction.They were not able to move the device at all due to the resistance.There was no attempt to torque the device.There was no evidence of physical material within the device.Other devices were successfully used with the concomitant device prior to the encountered resistance.The microcatheter used was a prowler select plus (product and lot number unknown).The prowler select plus was not removed with the stent when impeded, therefore, there was no cerebral target loss.The mc did not kink or bent.The target vessel/site was the basilar tip.There were no procedural delays due to the event.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.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during the use of an eu 4.5x28mm intracranial stent 12 mm dw tip (enc452812, 8302859), the physician started to release stent after it was placed in target site.The distal markers of the stent did not fully open or expand as intended.It was withdrawn to deliver it again, but the stent was impeded in proximal of unspecified microcatheter (mc) and could not advance any more.Doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.Additional information received on 21-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 prior to the incomplete expansion.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion.There was no additional intervention performed to attempt to expand the stent.There was no blood flow restriction.They were not able to move the device at all due to the resistance.There was no attempt to torque the device.There was no evidence of physical material within the device.Other devices were successfully used with the concomitant device prior to the encountered resistance.The microcatheter used was a prowler select plus (product and lot number unknown).The prowler select plus was not removed with the stent when impeded, therefore, there was no cerebral target loss.The mc did not kink or bent.The target vessel/site was the basilar tip.There were no procedural delays due to the event.A non-sterile 4.5mm x 28mm enterprise® 12mm tip vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed and dried saline residues were noted inside the introducer tube.No appearance of damages was noted the stent remained attached to the delivery system.The delivery wire was inspected under microscope, and the distal coil tip was found slightly stretched and kinked.A considerable amount of residues of dried saline solution were noted along the delivery wire.A functional test was performed in which the enterprise system was secured into a lab sample microcatheter through a lab sample syringe and hemostasis valve (rhv).The system was flushed, and the enterprise system was advanced through the microcatheter without noticeable resistance.The stent was deployed and inspected under magnification.No abnormalities were found on it (i.E., no broken struts, no kinks).Both stent ends were noted to be completely expanded.The issue reported regarding the stent being impeded in the proximal section of the microcatheter was not able to be confirmed since the device performed successfully during the functional test.Is possible that the kink condition found in the delivery wire appeared during the retraction of the system into the introducer tube where the tip of the introducer was not properly engaged with the unspecified microcatheter hub, force may have been inadvertently applied in an attempt to overcome the difficulties experienced.The issue reported regarding the distal markers of the stent not being fully opened was not confirmed since the stent fully expanded during the analysis.It is possible that the marker bands may have converged together but apposed to the vessel wall.Although no product defect was identified, there may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.There is no indication that the issues reported in the complaint are a result of 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 8302859.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.Since no issues were encountered, 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: maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage.Position the stent for deployment by aligning the stent positioning marker of the delivery wire with the target site.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).Section b5: additional event information received indicated that a prowler select microcatheter was used with the enterprise stent.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EU 4.5X28MM STENT 12 MM DW 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: 18170726
• MDR Text Key: 328542556
• Report Number: 3008114965-2023-00873
• 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,Followup,Followup
• Report Date: 02/21/2024

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: ENC452812
• Device Lot Number: 8302859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 12/04/2023; 12/28/2023; 02/06/2024
• Supplement Dates FDA Received: 11/21/2023; 12/14/2023; 01/16/2024; 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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: PRODUCT SELECT PLUS MICROCATHETER.; UNSPECIFIED MICROCATHETER.