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); Failure to Advance (2524)

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

Event Date 11/19/2023

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).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.

Event Description

As reported by the field, during a stent assist coil embolization, an eu 4.5x22mm intracranial stent 12 mm dw tip enc (b)(4) in the distal end of an unspecified microcatheter (mc), the stent could not pass through the microcatheter (mc).The physician retracted the stent and observed that the delivery wire broke into two pieces in introducer sheath.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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 information received on 07-dec-2023 indicated that the microcatheter used was a prowler select plus (606s255x, 3113003).There was no evidence of physical material within the device.No other devices were used with the concomitant device prior to the encountered resistance.It was not necessary to remove the mc with the enterprise, there was no cerebral target loss.No additional intervention was needed to remove the device from the patient.There was no evidence of fragments remaining in the patient.The distal tip of the enterprise was not re-shaped prior to use.There were no procedural delays due to the event.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).Complaint conclusion: as reported by the field, during a stent assist coil embolization, an eu 4.5x22mm intracranial stent 12 mm dw tip (enc452212, 8137618) in the distal end of an unspecified microcatheter (mc), the stent could not pass through the microcatheter (mc).The physician retracted the stent and observed that the delivery wire broke into two pieces in introducer sheath.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional information received on 07-dec-2023 indicated that the microcatheter used was a prowler select plus (606s255x, 3113003).There was no evidence of physical material within the device.No other devices were used with the concomitant device prior to the encountered resistance.It was not necessary to remove the mc with the enterprise, there was no cerebral target loss.No additional intervention was needed to remove the device from the patient.There was no evidence of fragments remaining in the patient.The distal tip of the enterprise was not re-shaped prior to use.There were no procedural delays due to the event.A non-sterile eu 4.5x22mm intracranial stent 12 mm dw tip stent was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent component was returned inside the introducer tube.Microscopic inspection revealed that the delivery wire was broken.No damages were noted in the stent.The introducer was found to be undamaged (i.E., no kinks, bents o elongations).Residues of dried saline solution were found inside the introducer.The issue reported regarding the stent being impeded in the distal end of the microcatheter could not be evaluated through a functional test; the broken condition of the delivery wire prevents the ability to move forward the delivery system and perform the proper functional analysis.However, the reported issue can be confirmed based on such damage, which suggests that the device was subjected to certain manipulation in an attempt to overcome the difficulties experienced that could also have caused the delivery wire to be broken during the withdrawal.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the manufacture of the device.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8137618.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent this type of damages from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.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.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.

• 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: 18256582
• MDR Text Key: 330462034
• Report Number: 3008114965-2023-00920
• 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,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: 8137618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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; UNKNOWN MICROCATHETER
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian