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)

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

Event Date 01/14/2024

Event Type  malfunction  

Event Description

As reported by the field, during an endovascular embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8254500) became impeded in proximal of a prowler select plus 150/5cm (606s255x, lot unknown) microcatheter (mc) and could not advance any more.The physician removed the microcatheter and stent from the patient and switched to new devices to complete the surgery.The stent body was found to be separated prematurely from the delivery wire.There was no patient injury reported.No additional information is available.

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) section h3 - 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.The company is seeking this information through the event investigation.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 3008114965-2024-00220.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8254500) became impeded in proximal of a prowler select plus 150/5cm (606s255x, lot unknown) microcatheter (mc) and could not advance any more.The physician removed the microcatheter and stent from the patient and switched to new devices to complete the surgery.The stent body was found to be separated prematurely from the delivery wire.There was no patient injury reported.No additional information is available.Additional event information received on 28-feb-2024 indicated that the indicated procedure was a stent-assist embolization of aneurysm.There were no procedural delays.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 noted that the stent was already detached from the unit.The delivery wire and the introducer were found to be in good condition (i.E., no kinks, bents, or elongations).The stent component was inspected under microscopic magnification, and it was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks).Both ends were noted as completely flared.The introducer was confirmed to be within specifications for the outer diameter (od) and the distal inner diameter (id).The delivery wire was subjected to dimensional analysis and all measurements were found to be within specification, including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The issue documented that the stent became impeded in the proximal section of the microcatheter cannot be evaluated through a functional test since during the analysis, the stent was found to be no longer on the delivery wire.Based on this condition the issue regarding a stent being prematurely detached was confirmed.It is possible that the delivery wire was pulled sufficiently to disengage it from the stent in the attempt to retract the stent; however, with the evidence available, a clear relationship between this finding and the issue reported cannot be drawn at this time.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the enterprise device.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8254500.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.Since there is no evidence to suggest that the issue encountered during the procedure is related to the design or manufacture of the device, no capa activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: ¿ the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional event information received on 28-feb-2024 indicated that the indicated procedure was a stent-assist embolization of aneurysm.There were no procedural delays.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: 18694842
• MDR Text Key: 335323927
• Report Number: 3008114965-2024-00220
• 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: Followup,Followup
• Report Date: 04/02/2024

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 Catalogue Number: ENC452212
• Device Lot Number: 8254500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 03/20/2024
• Supplement Dates FDA Received: 03/13/2024; 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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.