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

Model Number 641CF3575

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).The photos accompanied with the complaint file were visually analyzed.In them, it could be observed that the delivery wire was broken in two pieces inside the hoop dispenser, this condition is consistent with the customer complaint regarding a broken condition on the delivery wire.The costumer complaint regarding the device being impeded in the introducer could not be evaluated based on the photo provided since this failure requires functional test, however, the broken condition observed on the delivery wire, could be the result of the impeded condition reported.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6812660.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The customer complaint was confirmed.This investigation was performed based only on the photos provided and no further investigation will be performed since the device said to be involved was reported as discarded.The company is seeking this information through the event investigation.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.

Event Description

As reported by the field, during stent-assist coil embolization, a 4.5 x 22mm enterprise stent 12 mm dw tip (enc452212, 6812660) became impeded in the introducer sheath and could not be pushed out.The physician adjusted the stent, but the delivery wire broke into 2 pieces.The stent was not used in the patient, therefore there was no patient injury.A new device was changed to complete the surgery.Pictures have been provided.No further information is available at this time.

Manufacturer Narrative

Product complaint # (b)(4).Updated section on this medwatch report: b4, b5, g3, g6, h2 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that the introducer was properly engaged with the infusion catheter hub.They were able to torque the device.The advancement difficulty was felt at the bracket clips into the guide sheath.The stent is stuck in the guide sheath and cannot be seen with naked eyes.No excessive force was applied to the device.It was noted that the event was found during device check.The system was used with the recommended microcatheter, however, the microcatheter had not been pushed yet.The replacement stent was of the same size as the original one.Complaint conclusion: as reported by the field, during stent-assist coil embolization, a 4.5 x 22mm enterprise stent 12 mm dw tip (enc452212, 6812660) became impeded in the introducer sheath and could not be pushed out.The physician adjusted the stent, but the delivery wire broke into 2 pieces.The stent was not used in the patient, therefore there was no patient injury.A new device was changed to complete the surgery.Pictures have been provided.Additional information received indicated that the introducer was properly engaged with the infusion catheter hub.They were able to torque the device.The advancement difficulty was felt at the bracket clips into the guide sheath.The stent is stuck in the guide sheath and cannot be seen with naked eyes.No excessive force was applied to the device.It was noted that the event was found during device check.The system was used with the recommended microcatheter, however, the microcatheter had not been pushed yet.The replacement stent was of the same size as the original one.The photos accompanied with the complaint file were visually analyzed.In them, it could be observed that the delivery wire was broken in two pieces inside the hoop dispenser, this condition is consistent with the customer complaint regarding a broken condition on the delivery wire.The costumer complaint regarding the device being impeded in the introducer could not be evaluated based on the photo provided since this failure requires functional test, however, the broken condition observed on the delivery wire, could be the result of the impeded condition reported.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6812660.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Based on the visual analysis of the pictures receive, the customer complaint was confirmed.This investigation was performed based only on the photos provided and no further investigation will be performed since the device said to be involved was reported as discarded.Impeded-in introducer and fractured-separated during use are known potential product failures associated with the use of the device.The instructions for use (ifu) contain the following warnings: the device is designed to be manipulated while under high-quality fluoroscopic observation.If resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.If resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to un-sheath the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.The ifu also instructs to advance the delivery wire to transfer the stent from the introducer into the infusion catheter.Warns that the delivery wire should not be torqued to gain access into the aneurysm.Continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.Warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that device manipulation / interaction may have contributed to the reported issues.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14434686
• MDR Text Key: 294882810
• Report Number: 3008114965-2022-00350
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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 Expiration Date: 11/28/2023
• Device Model Number: 641CF3575
• Device Catalogue Number: ENC452212
• Device Lot Number: 6812660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2021
• 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