MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452200

Device Problem Activation Failure (3270)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 an endovascular embolization, an eu ent4.5mmd 22mml wno dstl tp intracranial stent (enc452200, 7332335) was placed in target position and started to release, but the distal markers of the stent were converged which could not be opened as expected.The doctor retracted the stent and the prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and then switched to new devices to complete the surgery.

Manufacturer Narrative

Product complaint (b)(4).Section b5: additional event information received on 22-apr-2024 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.The stent did not appear damaged.There were no procedural delays due the event.There was no alleged product malfunction with the prowler select.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 an endovascular embolization, an eu ent4.5mmd 22mml wno dstl tp intracranial stent (enc452200, 7332335) was placed in target position and started to release, but the distal markers of the stent were converged which could not be opened as expected.The doctor retracted the stent and the prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and then switched to new devices to complete the surgery.Additional event information received on 22-apr-2024 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.The stent did not appear damaged.There were no procedural delays due the event.There was no alleged product malfunction with the prowler select.A non-sterile eu ent4.5mmd 22mml wno dstl tp 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 introducer and the delivery wire were found to be in good conditions (i.E., no kinks, bents or elongations).The stent component was inspected under a microscope and no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the stent ends were noted to be completely expanded.No other damages were found.The customer complaint regarding stent marker bands not being fully opened was not confirmed since the stent was noted as already expanded on both ends.It is possible that the marker bands may have converged together but apposed to the vessel wall during the procedure.The stent detachment was not originally documented in the complaint, and the exact time when this condition occurred cannot be determined; however, this finding is not a contributing factor to the stent's inability to open during the procedure.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.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 7332335.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.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: ¿ maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage.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: EU ENT4.5MMD 22MML WNO DSTL TP
• 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: 19059208
• MDR Text Key: 340473575
• Report Number: 3008114965-2024-00376
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452200
• Device Lot Number: 7332335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2022
• 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
• Treatment: PROWLER SELECT PLUS 150/5CM
• Patient Age: 56 YR
• Patient Sex: Male