MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452200

Device Problems Premature Activation (1484); Material Separation (1562); Failure to Advance (2524)

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

Event Date 09/25/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).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.Based on the visual analysis of the photos provided for this complaint, it can be determined that the delivery wire of the eu ent4.5mmd 22mml wno dstl tp has a broken condition; the distal body of the delivery wire could be noted separated in two parts.The stent could be noted deployed outside from the introducer and no damages could be noted in it.No other damages could be noted.The introducer was not shown in the picture.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6357987.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The reported condition ¿delivery wire- impeded in microcatheter with no loss of cerebral target position¿ could not be evaluated based on the pictures.The reported condition ¿stent - deployment difficulty-premature/in microcatheter hub¿ could not be evaluated based on the pictures.The reported condition ¿delivery wire- fractured/separated-during use¿ was confirmed since the delivery wire could be noted broken in two parts.The dhr suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed once the device returns for analysis.Complaint trends are monitored on a monthly basis as part of the company post market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00517.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-assisted coil embolization of aneurysms, the delivery wire of an enterprise 4.5mmd x 22mml with no distal tip (enc452200 , 6357987 ) was not able to arrive at distal of a prowler select lpes microcatheter (606s155x, 30499442).The microcatheter was removed.It was found to be kinked, switched to another one.The enterprise stent was impeded and could not advance anymore during its delivery to microcatheter.The physician inspected and observed the stent had released in y connector, withdrew the device, found the delivery wire was broken.Changed to another stent to complete the surgery.There was no patient injury.Pictures have been provided.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that the introducer was fully seated and secured in the hub.They were able to torque the device.There was no evidence of physical material within the devices.No other devices were successfully used with the concomitant device after the encountered resistance.The prowler mc was removed with the enterprise and not used to complete the procedure.No additional intervention was needed to remove the device from the patient.The event did not cause prolongation during the procedure.There were no damages to the prowler select.It is unknown if the replacement stent was of the same size as the original one.There was resistance felt within the mc.There was no evidence of fragments remaining in the patient.The distal tip of the enterprise was not re-shaped prior to use.No excessive force was applied to the device.Adequate flush was maintained through the devices.Treatment was to a basilar artery apical aneurysm.

Manufacturer Narrative

Product complaint #(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.

Manufacturer Narrative

Product complaint # (b)(4).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 a stent-assisted coil embolization of aneurysms, the delivery wire of an enterprise 4.5mmd x 22mml with no distal tip (enc452200 , 6357987 ) was not able to arrive at distal of a prowler select lpes microcatheter (606s155x, 30499442).The microcatheter was removed.It was found to be kinked, switched to another one.The enterprise stent was impeded and could not advance anymore during its delivery to microcatheter.The physician inspected and observed the stent had released in y connector, withdrew the device, found the delivery wire was broken.Changed to another stent to complete the surgery.There was no patient injury.Additional information received indicated that the introducer was fully seated and secured in the hub.They were able to torque the device.There was no evidence of physical material within the devices.No other devices were successfully used with the concomitant device after the encountered resistance.The prowler mc was removed with the enterprise and not used to complete the procedure.No additional intervention was needed to remove the device from the patient.The event did not cause prolongation during the procedure.There were no damages to the prowler select.It is unknown if the replacement stent was of the same size as the original one.There was resistance felt within the mc.There was no evidence of fragments remaining in the patient.The distal tip of the enterprise was not re-shaped prior to use.No excessive force was applied to the device.Adequate flush was maintained through the devices.Treatment was to a basilar artery apical aneurysm.Based on the visual analysis of the photos provided for this complaint, it can be determined that the delivery wire of the eu ent4.5mmd 22mml wno dstl tp has a broken condition; the distal body of the delivery wire could be noted separated in two parts.The stent could be noted deployed outside from the introducer and no damages could be noted in it.No other damages could be noted.The introducer was not shown in the picture.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6357987.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The product was returned to cerenovus for evaluation.A visual inspection was conducted on the returned device.The visual analysis of the returned sample revealed that the delivery wire was apparently mechanically broken off at the tip section, the introducer was inspected, and it was found in good normal conditions.No other damages or anomalies were found during the analysis.Due to the apparent mechanical breakage condition noted on the delivery wire, scanning electron microscope (sem) testing was performed, the results of the scanning electron microscope (sem) test are as follows: there is evidence of mechanical damage.These damages could be related to excessive force used during the procedure; however, this cannot be conclusively determined.No other anomalies were observed.Due to the broken condition observed on the delivery wire, the customer complaint regarding ¿delivery wire - fractured/separated-during use¿ was confirmed.The customer complaint regarding ¿delivery wire - impeded in microcatheter with no loss of cerebral target position¿ could not be evaluated, due to the stent was not returned for evaluation.Although the stent was not returned for analysis, the customer complaint regarding ¿stent - deployment difficulty-premature/in microcatheter hub¿ was confirmed, due to the photos provided by the customer, the stent was detached out of the target position, however there is no evidence of a detachment inside the microcatheter hub.A device history record evaluation was performed, and no non-conformances were identified.Impeded in microcatheter, premature deployment and fracture during use are potential complications when using this device.It should be noted that product failure is multifactorial.The instructions for use contain the following warnings: ¿ the device is designed to be manipulated while under high-quality fluoroscopic observation.If resistance is met during manipulation, determine the cause of resistance before proceeding.¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to un-sheath the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.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 ENT4.5MMD 22MML WNO DSTL TP
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12648016
• MDR Text Key: 281217799
• Report Number: 3008114965-2021-00518
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: ENC452200
• Device Lot Number: 6357987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT LPES.