MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

As reported by the field, during an endovascular embolization, after delivering an unspecified stent to the target site and the stent implanted successfully, the same prowler select plus 150/5cm microcatheter (606s255x, 31168629) was used to deliver a second stent, an eu 4.5x14mm stent 12 mm dw tip intracranial stent (enc451412, 7507663) to the other posterior cerebral artery again.The stent became impeded at the distal end of the microcatheter (mc) and could not pass through the microcatheter.The physician removed the stent and microcatheter together from the patient's body, and then replaced it with a new microcatheter, a prowler select plus 150/5cm (606s255x, 31168629) to deliver the same stent.The stent was still impeded at the distal end of the second microcatheter and could not pass through the microcatheter.When attempting to deliver the stent, the stent was released in the microcatheter.The stent body was separated from the microcatheter prematurely, and the delivery wire of the stent was fractured.The physician removed the second microcatheter and stent from the patient and changed a new device to complete the surgery.The surgery was prolonged about 20 minutes.Additional event information received on 28-mar-2024 indicated that the microcatheters did not kinked/bent.The target site was the basilar tip.

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.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 three products involved with the complaint and the associated manufacturer report numbers are, 3008114965-2024-00378 and 3008114965-2024-00379.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, after delivering an unspecified stent to the target site and the stent implanted successfully, the same prowler select plus 150/5cm microcatheter (606s255x, 31168629) was used to deliver a second stent, an eu 4.5x14mm stent 12 mm dw tip intracranial stent (enc451412, 7507663) to the other posterior cerebral artery again.The stent became impeded at the distal end of the microcatheter (mc) and could not pass through the microcatheter.The physician removed the stent and microcatheter together from the patient's body, and then replaced it with a new microcatheter, a prowler select plus 150/5cm (606s255x, 31168629) to deliver the same stent.The stent was still impeded at the distal end of the second microcatheter and could not pass through the microcatheter.When attempting to deliver the stent, the stent was released in the microcatheter.The stent body was separated from the microcatheter prematurely, and the delivery wire of the stent was fractured.The physician removed the second microcatheter and stent from the patient and changed a new device to complete the surgery.The surgery was prolonged about 20 minutes.Additional event information received on 28-mar-2024 indicated that the microcatheters did not kinked/bent.The target site was the basilar tip.A non-sterile eu 4.5x14mm stent 12 mm dw tip was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the stent was detached from the delivery system and remained inside the introducer.The stent component was inspected under microscopic magnification and it was found disengaged from the delivery wire; no damages were observed on it.Further inspection revealed that the delivery wire was bent and broken off; the fragment of the delivery wire was within the stent inside the introducer.The conditions in which the enterprise system was returned precluded functional testing.However, these suggest that the delivery wire was pushed sufficiently to cause the delivery wire to bend and end up breaking.It is suggested that the delivery system was handled with the use of excessive force, enough to release the stent inside of the introducer tube.The issue reported was confirmed, however, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 7507663.The history records indicate 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) contain the following recommendations: ¿ if resistance is met during manipulation, determine the cause of resistance before proceeding.¿ the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.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 4.5X14MM 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: 19059528
• MDR Text Key: 340466980
• Report Number: 3008114965-2024-00377
• 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: 05/06/2024

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: ENC451412
• Device Lot Number: 7507663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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.
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: Asian