MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

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

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

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (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.Two pictures were attached to the complaint file and the device was seen inside a plastic glove.It was noted that the delivery wire and the introducer are separated.The stent was not able to be seen in the picture, however, it was noted that it was already detached from the delivery wire.No damages were noted in the device.A device history record (dhr) was performed and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.The customer complaint was not able to be evaluated since a functional analysis needs to be performed and the stent was not able to be seen in the picture.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, this was a stent assist coil embolization to the internal carotid artery communicating segment aneurysm, confirmed by angiography.After a prowler select plus microcatheter (30743230, unknown lot) was delivered in place, an enterprise2 4mmx23mm intracranial stent (encr402312, 6441630) was delivered.When delivery wire was delivered to the y connector of the microcatheter more than 40 cm, the stent could not advance any more, and it can only be retracted.After several attempts, it still failed to advance.The physician withdrew the stent and tried to deliver it again, but it was impeded in y connector and could not advance or withdraw.After adjusting, the doctor tried to retract the stent to introducer sheath, but it failed to be back in the introducer sheath.The stent body was found to be deformed.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 the introducer was fully seated and secured in the y valve.A torque devise was not used.There was no evidence of physical material within the device.A synchro guide wire was successfully passed prior to the encountered resistance.The replaced stent was of the same size as the original one.No excessive force was used with the device.There were no procedural delays due to the event.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, this was a stent assist coil embolization to the internal carotid artery communicating segment aneurysm, confirmed by angiography.After a prowler select plus microcatheter (30743230, unknown lot) was delivered in place, an enterprise2 4mmx23mm intracranial stent (encr402312, 6441630) was delivered.When delivery wire was delivered to the y connector of the microcatheter more than 40 cm, the stent could not advance any more, and it can only be retracted.After several attempts, it still failed to advance.The physician withdrew the stent and tried to deliver it again, but it was impeded in y connector and could not advance or withdraw.After adjusting, the doctor tried to retract the stent to introducer sheath, but it failed to be back in the introducer sheath.The stent body was found to be deformed.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 the introducer was fully seated and secured in the y valve.A torque devise was not used.There was no evidence of physical material within the device.A synchro guide wire was successfully passed prior to the encountered resistance.The replaced stent was of the same size as the original one.No excessive force was used with the device.There were no procedural delays due to the event.Two pictures were attached to the complaint file and the device was seen inside a plastic glove.It was noted that the delivery wire and the introducer are separated.The stent was not able to be seen in the picture, however, it was noted that it was already detached from the delivery wire.No damages were noted in the device.A non-sterile enterprise2 4mmx23mm 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 delivery wire, as seen in the provided picture, and it was not returned for evaluation.The delivery wire and the introducer were found without damage (i.E., no kinks, bents, or elongations).The impeded condition and the stent damage, as reported, could not be evaluated in the lab due to the stent was not returned.The stent must be still inside the introducer tube to perform the functional analysis.The stent detachment was not originally reported in the complaint, the exact time when this condition occurred could not be determined and it is not considered secondary to the failure reported according to the information available.Even though the functional test could not be performed, no damages were found in the returned device that contributed to the reported failure.This suggests that the enterprise was not fully seated in the hub of the microcatheter, which caused the stent to be unable to advance through.The impeded condition in the y connector experienced during the procedure could not be replicated in the lab.Other circumstances or issues may occur while using the device that could not be replicated during the analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of lot 6441630.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) 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 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 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: ENTERPRISE2 4MMX23MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16094197
• MDR Text Key: 308624338
• Report Number: 3008114965-2023-00005
• 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: 01/26/2023

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: ENCR402312
• Device Lot Number: 6441630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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; SYNCHRO GUIDE WIRE
• Patient Sex: Female