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

Catalog Number ENC452212

Device Problems Material Separation (1562); Component Missing (2306)

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

Event Date 10/08/2022

Event Type  malfunction  

Event Description

As reported by the field, during the prepping of an eu 4.5x22mm stent 12 mm dw tip (enc452212, 6441605) was found that the marker of the tip of the stent was lost.Also, the delivery wire broke, which could not be used to deliver the stent.A new stent was changed to complete the surgery.There was no patient injury reported as the device was not used in the patient.There had been no difficulty attaching another device to the complaint device.No excessive force was applied to the device.The device was examined prior to use.No resistance was felt when using the device.The physician immediately changed a new device, there were no procedural delays.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).Device evaluated by mfr: 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.Three pictures were attached to the complaint file it can be noted that the delivery wire is broken in two parts.Also, it was noted the deployed stent, and due to the blurriness of the picture, it cannot be determined if one of the marker bands is lost.The distal ends can be noted as not completely flared.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.The customer complaint was confirmed based on the broken condition noted in the delivery wire.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during the prepping of an eu 4.5x22mm stent 12 mm dw tip (enc452212, 6441605) was found that the marker of the tip of the stent was lost.Also, the delivery wire broke, which could not be used to deliver the stent.A new stent was changed to complete the surgery.There was no patient injury reported as the device was not used in the patient.There had been no difficulty attaching another device to the complaint device.No excessive force was applied to the device.The device was examined prior to use.No resistance was felt when using the device.The physician immediately changed to a new device, there were no procedural delays.No additional information is available.Three pictures were attached to the complaint file it can be noted that the delivery wire is broken in two parts.Also, it was noted the deployed stent, and due to the blurriness of the picture, it cannot be determined if one of the marker bands is lost.The distal ends can be noted as not completely flared.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 delivery wire was separated into two fragments.The introducer was not returned for evaluation.No other damages were found.The stent component was inspected under a microscope, and it was noted that both of the distal ends were broken, and one of the marker bands was missing.The distal fragment of the delivery wire was noted to be in a bent condition next to the marker band.With the evidence available, the issue documented that the delivery wire broke can be confirmed based on the appearance of the returned device.Also, it was confirmed that one of the distal marker bands was missing due to the broken condition of the stent; these damages suggest that excessive force may have inadvertently been exerted on the enterprise system during prepping of the procedure.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.There is no indication that the issues reported in the complaint are a result of a defect inherently related to the enterprise device.The detached condition found in the stent was not originally reported in the complaint, and this may have occurred during the manipulation required during the prepping of the device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of lot 6441605.The historical 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.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15632500
• MDR Text Key: 307065221
• Report Number: 3008114965-2022-00672
• 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: 12/05/2022

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: 05/28/2023
• Device Catalogue Number: ENC452212
• Device Lot Number: 6441605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2022
• Initial Date FDA Received: 10/19/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• 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