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

Catalog Number ENC452212

Device Problem Failure to Advance (2524)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 6812660) became impeded in a prowler select plus 150/5cm (606s255x, 30654776) microcatheter (mc) and could not advance anymore.The physician retracted the stent and microcatheter and switched to new devices to complete the surgery.There was no patient injury reported.Additional information received indicated that the resistance was felt at the body/shaft of the device.The mc did not become kinked prior to the encountered resistance.No other devices were successfully used with the concomitant device prior to the encountered resistance.The replacement stent was of the same size as the original one (4.5mm x 22mm).Adequate flush was maintained through the devices.There were no procedural delays due to the vent.

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 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.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00719.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).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a stent assist coil embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 6812660) became impeded in a prowler select plus 150/5cm (606s255x, 30654776) microcatheter (mc) and could not advance anymore.The physician retracted the stent and microcatheter and switched to new devices to complete the surgery.There was no patient injury reported.Additional information received indicated that the resistance was felt at the body/shaft of the device.The mc did not become kinked prior to the encountered resistance.No other devices were successfully used with the concomitant device prior to the encountered resistance.The replacement stent was of the same size as the original one (4.5mm x 22mm).Adequate flush was maintained through the devices.There were no procedural delays due to the vent.No additional information is available.A non-sterile eu 4.5x22mm stent 12 mm dw tip was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was observed that the stent was returned detached from the delivery wire.The stent component was inspected under microscopic magnification, and it was observed to be undamaged.The impeded condition, as reported, could not be tested in the lab due to the stent detachment.The complaint information detailed that the resistance was felt at the body/shaft of the device; it would be unlikely that the stent became detached as a result of excessive force exerted on the enterprise system to make the stent pass through the microcatheter, as the stent would have become detached inside the microcatheter.The stent detachment was not originally reported in the complaint and the most likely time when this condition occurred may be during the post-operative handling as it was received expanded and deployed outside the introducer and microcatheter.The appearance of the stent component does not suggest that it was subjected to excessive force/manipulation because of the impeded condition encountered during the procedure.It is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.The customer complaint in relation to the stent becoming impeded in the microcatheter cannot be evaluated.With the amount of information available, there is no indication that the issue reported in the complaint results from a defect inherently related to the enterprise device.A device history record (dhr) of lot number 6812660 was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15727825
• MDR Text Key: 306989957
• Report Number: 3008114965-2022-00718
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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 Catalogue Number: ENC452212
• Device Lot Number: 6812660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PROWLER SELECT PLUS 150/5CM