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

Catalog Number ENC452212

Device Problems Premature Activation (1484); Failure to Advance (2524); Material Twisted/Bent (2981)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (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.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.

Event Description

As reported by the field, during treatment to the right middle cerebral artery (m1 segment stenosis), an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8028680) was passed through y connector and the hub of a prowler select plus microcatheter (606s255x, 31024383).However, the stent became impeded in proximal of the microcatheter and could not advance any more.The stent was removed for inspection, the physician delivered the stent, however, encountered resistance in the introducer sheath.The physician added some force to deliver the delivery wire, the stent body was separated from the delivery wire.The delivery wire of the stent was found to be kinked/bent.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional information was received indicating that no prior coils had been advanced through the same microcatheter.After the resistance, the physician retracted the device into introducer sheath.The device was able to be torqued.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.It was not necessary to remove the microcatheter with the enterprise.The microcatheter did not kink.There were no procedural delays due to the event.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during treatment to the right middle cerebral artery (m1 segment stenosis), an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8028680) was passed through y connector and the hub of a prowler select plus microcatheter (606s255x, 31024383).However, the stent became impeded in proximal of the microcatheter and could not advance any more.The stent was removed for inspection, the physician delivered the stent, however, encountered resistance in the introducer sheath.The physician added some force to deliver the delivery wire, the stent body was separated from the delivery wire.The delivery wire of the stent was found to be kinked/bent.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional information was received indicating that no prior coils had been advanced through the same microcatheter.After the resistance, the physician retracted the device to introducer sheath.The device was able to be torqued.There was no evidence of physical material within the device.No other devices were successfully used with the concomitant device prior to the encountered resistance.It was not necessary to remove the microcatheter with the enterprise.The microcatheter did not kink.There were no procedural delays due to the event.Four pictures accompanied the complaint file, and it was noted that the stent already detached from the unit and both ends can be noted as completely flared.The delivery wire was observed to have a kinked condition.No other damages were noted.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of the lot 8028680.The history records indicate 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.Therefore, no capa activity is required.The described event was confirmed based on the detachment condition of the stent and the damaged condition of the delivery wire; this can be the result of the force applied once it became stuck.This investigation was performed based only on the photos provided.The device was reported as discarded.No further evaluation of contributing factors can be conducted.The instructions for use (ifu) contain the following recommendations: ¿ do not apply undue force if resistance is encountered at any point during stent manipulation.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18216803
• MDR Text Key: 329126822
• Report Number: 3008114965-2023-00890
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Device Lot Number: 8028680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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.