MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF3575

Device Problem Activation Problem (4042)

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

Event Date 01/06/2022

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist embolization, a 4.5x22mm enterprise intracranial neurovascular stent 12mm dw tip (enc452212, 6610122) passed through the prowler select plus microcatheter (606s255x, 30452037).The physician tried to release the stent, but it could not be opened, the physician retracted the stent a little for adjusting and intended to open the stent again, but still failed.The enterprise was recaptured into the microcatheter and removed.A new stent was switched to complete the surgery.There was no patient injury report.Additional information received indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There had not been any resistance during advancement of the device.The stent did not appear damaged.There were no vessel or aneurysm factors that contributed to the incomplete expansion.There was no blood flow restriction.An adequate flush was maintained through the devices.There was no prolongation in the procedure due to the event.The concomitant devices functioned as expected.Based on the analysis of the device received, the stent was found bent.

Manufacturer Narrative

Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The stent of the device involved was found bent, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Complaint conclusion: as reported by the field, during a stent assist embolization, a 4.5x22mm enterprise intracranial neurovascular stent 12mm dw tip (enc452212, 6610122) passed through the prowler select plus microcatheter (606s255x, 30452037).The physician tried to release the stent, but it could not be opened, the physician retracted the stent a little for adjusting and intended to open the stent again, but still failed.The enterprise was recaptured into the microcatheter and removed.A new stent was switched to complete the surgery.There was no patient injury report.Additional information received indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There had not been any resistance during advancement of the device.The stent did not appear damaged.There were no vessel or aneurysm factors that contributed to the incomplete expansion.There was no blood flow restriction.An adequate flush was maintained through the devices.There was no prolongation in the procedure due to the event.The concomitant devices functioned as expected.A non-sterile unit eu 4.5x22mm stent 12 mm dw tip was received inside of a pouch.The stent component was returned separated from the delivery wire.The proximal delivery wire marker was noted to be kinked.One of the stent marker bands was noted to be kinked.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6610122.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The product was returned to cerenovus for further evaluation.Upon arrival, it was noted that the introducer was not returned for evaluation.The stent component was returned separated from the delivery wire; this condition might have occurred during the post-operative handling or decontamination process as it is not covered by the event description.The proximal delivery wire marker was noted to be kinked, under microscopic magnification, one of the stent marker bands was noted to be kinked.These damages could be related to the deployment difficulty encountered during the procedure and could be secondary to the manipulation required to advance and retract the stent from the microcatheter; however, since the stent component was returned separated from the unit for evaluation no further testing could be performed and no contributing factors could be identified from the components.Since the concomitant microcatheter was not facilitated in the lab, no additional evaluation could be performed.A device history record evaluation was performed, and no non-conformances were identified.It should be noted that product failure could be caused by multiple factors.Deployment difficulty is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The instructions for use (ifu) does contain the following recommendation: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: EU 4.5X22MM 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13869218
• MDR Text Key: 297705737
• Report Number: 3008114965-2022-00219
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009495
• UDI-Public: 10878528009495
• 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
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: 641CF3575
• Device Catalogue Number: ENC452212
• Device Lot Number: 6610122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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