MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X37MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453712

Device Problems Difficult to Advance (2920); Activation Failure (3270)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted aneurysm embolization procedure, the physician encountered resistance when the complaint stent, a 4.5mm x 37mm enterprise® vascular reconstruction device (enc453712 / 7161632) was delivered to 2/3 of the 150cm x 5cm prowler select plus microcatheter (606s255x / 30887537).After the stent was placed in the target position, it was found that the stent tip was unable to open.The physician retracted the stent and the microcatheter and replaced both devices to complete the procedure.It was reported that the patient is currently stable.The procedure was prolonged about 30 minutes.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7161632.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00303.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 31-may-2023.[additional information]: on 31-may-2023, additional information was received.The information indicated that the location of the target aneurysm was not known; the target was an unruptured aneurysm.There was no evidence of obstructed blood flow due to the reported issue.The temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.During advancement of the stent, there was some resistance noted at approximately 100cm from the microcatheter hub.The incomplete expansion did not result in stent migration or embolization of the stent.Adequate continuous flush had been maintained through the microcatheter.There were no visible kinks or other damages observed on the microcatheter.The stent component was still on the delivery wire when it was removed from the patient.The stent / stent delivery system did not appear damage.Nothing unusual was noted about the system prior to use.The replacement stent and the replacement microcatheter were not the same stent and the same microcatheter as the complaint devices.There was no patient adverse event or complication.The physician did not consider the 30-minute extension of the procedure to be clinically significant.Updated sections: b.4, g.3, g.6, h.2, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00302 and 3008114965-2023-00303.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 03-jul-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00302 and 3008114965-2023-00303.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.5mm x 37mm enterprise® vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent component was already detached from the unit.The stent component was inspected under a microscope.No abnormalities were observed on it (i.E., no broken struts, no kinks).Both ends of the stent were noted to be completely expanded.The delivery wire was also inspected and it was observed kinked and slightly stretched at the distal portion.No other damages were observed.The reported issue documented in the complaint regarding the stent tip not being able to open 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 is suggested that this condition appeared during the post-operational/shipping handling since it was reported that the stent was still on the delivery wire during the removal; however, this finding is not a contributing factor to the stent's inability to open experienced 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.The reported issue regarding the resistance felt during the advancement of the device could not be evaluated through functional test; the stent must be still attached to the delivery wire and inside the introducer tube to perform the functional analysis.However, the returned condition of the delivery wire suggests that it may have been subjected to certain manipulation during the stent advancement, resulting in the resistance felt, causing the delivery wire damage as observed.Nevertheless, this remains speculative, and the root cause of the resistance remains unknown.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7161632.The history record indicates 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.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.¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.Section h.6: investigation findings / investigation conclusions: the ¿no device problem found¿ code was used in the investigational findings because based on the microscopic inspection of the stent component, the reported issue documented in the complaint regarding the stent tip not being able to open was not confirmed since the stent was noted as already expanded on both ends.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00302 and 3008114965-2023-00303.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: EU 4.5X37MM 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 ; 303552-689
• MDR Report Key: 17027899
• MDR Text Key: 317460840
• Report Number: 3008114965-2023-00302
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: ENC453712
• Device Lot Number: 7161632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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.