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

Catalog Number ENC402312

Device Problem Failure to Advance (2524)

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

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref no: (b)(4).Information regarding the patient identifier and ethnicity was not provided.Race: the patient¿s race is reported to be mestizo.The 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.(b)(4) medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot: 7091646.The history record indicates this product was final inspection tested at (b)(4) medical and was determined to be acceptable.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that the patient with an aneurysm on the anterior communicating artery (acom) underwent a stent-assisted endovascular embolization procedure.The treatment plan involved two (2) stents and coils.For access, a sofia¿ 6f intermediate catheter (microvention) was used along with an 80cm cerebase da guide sheath (gs9080sd).After placing the guide catheters with their respective irrigation systems in each catheter, a 150cm x 5cm prowler select plus microcatheter (606s255x / 30704043) is passed with a hybrid 1214d guidewire (balt).There was difficulty in reaching the target site, the guidewire was changed to a mirage¿ 0.008" hydrophilic guidewire (medtronic), which is left in the target site.The 4mm x 20mm solitaire¿ stent retriever (medtronic) was raised, but due to the size of the vessel, it was removed and replaced with the complaint device, a 4.0mm x 23mm enterprise® 2 vascular reconstruction device (vrd) (enc402312 / 7091646).An attempt was made to pass the enterprise 2 vrd, but it could not be advanced even through the first third of the microcatheter.As a result, the stent and the microcatheter were removed and the microcatheter was flushed.Another attempt was made to advance the enterprise 2 vrd through the prowler select plus microcatheter, but the same issue occurred.It was introduced into the microcatheter but it could not be advanced beyond 30% of the microcatheter.The physician decided to remove the enterprise 2 vrd and used a competitor stent, a 3mm x 20mm solitaire¿ stent retriever (medtronic), which was introduced, delivered, and implanted in the target position.Subsequently, another competitor stent was placed on the other side of the aneurysm; this stent was also delivered via the prowler select plus microcatheter; there was no difficulty using the two competitor stents.Coil embolization was initiated with the required coils placed in the aneurysm via an echelon¿ 14 microcatheter (medtronic).There was no report of any negative patient impact.On 21-dec-2022, additional information was received.The information indicated that the patient is a 60-year-old male in good health, not taking any medication.Continuous flush was maintained through the microcatheter.When the stent component of the enterprise system was removed, it was still on the delivery wire; it did not advance beyond 30% of the microcatheter.The stent / stent delivery system was not damaged; this was the reason they proceeded to use the 4.0mm x 23mm enterprise stent again.Nothing unusual was noted about the system prior to use.The information indicated that ¿event after initially inserting the stent into the microcatheter twice and no more than the first third of the microcatheter, an attempt was made to open the stent in a bowl of water.The stent was seen to be opening without a problem, not even applying pressure.That's why he tried again to insert it through the microcatheter; but there was no success.It did not go beyond the same point, 30% of the microcatheter.¿ the same prowler select plus microcatheter was used to place the two stents that were finally placed in the patient.The prowler select plus microcatheter was used throughout the procedure and will be returned with the enterprise stent.The reported issue did not result in any procedure delay, nor any harm to the patient.The procedure was continued with the use of the competitor stents.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that the patient with an aneurysm on the anterior communicating artery (acom) underwent a stent-assisted endovascular embolization procedure.The treatment plan involved two (2) stents and coils.For access, a sofia¿ 6f intermediate catheter (microvention) was used along with an 80cm cerebase da guide sheath (gs9080sd).After placing the guide catheters with their respective irrigation systems in each catheter, a 150cm x 5cm prowler select plus microcatheter (606s255x / 30704043) is passed with a hybrid 1214d guidewire (balt).There was difficulty in reaching the target site, the guidewire was changed to a mirage¿ 0.008" hydrophilic guidewire (medtronic), which is left in the target site.The 4mm x 20mm solitaire¿ stent retriever (medtronic) was raised, but due to the size of the vessel, it was removed and replaced with the complaint device, a 4.0mm x 23mm enterprise® 2 vascular reconstruction device (vrd) (enc402312 / 7091646).An attempt was made to pass the enterprise 2 vrd, but it could not be advanced even through the first third of the microcatheter.As a result, the stent and the microcatheter were removed and the microcatheter was flushed.Another attempt was made to advance the enterprise 2 vrd through the prowler select plus microcatheter, but the same issue occurred.It was introduced into the microcatheter but it could not be advanced beyond 30% of the microcatheter.The physician decided to remove the enterprise 2 vrd and used a competitor stent, a 3mm x 20mm solitaire¿ stent retriever (medtronic), which was introduced, delivered, and implanted in the target position.Subsequently, another competitor stent was placed on the other side of the aneurysm; this stent was also delivered via the prowler select plus microcatheter; there was no difficulty using the two competitor stents.Coil embolization was initiated with the required coils placed in the aneurysm via an echelon¿ 14 microcatheter (medtronic).There was no report of any negative patient impact.On 21-dec-2022, additional information was received.The information indicated that the patient is a 60-year-old male in good health, not taking any medication.Continuous flush was maintained through the microcatheter.When the stent component of the enterprise system was removed, it was still on the delivery wire; it did not advance beyond 30% of the microcatheter.The stent / stent delivery system was not damaged; this was the reason they proceeded to use the 4.0mm x 23mm enterprise stent again.Nothing unusual was noted about the system prior to use.The information indicated that ¿event after initially inserting the stent into the microcatheter twice and no more than the first third of the microcatheter, an attempt was made to open the stent in a bowl of water.The stent was seen to be opening without a problem, not even applying pressure.That's why he tried again to insert it through the microcatheter; but there was no success.It did not go beyond the same point, 30% of the microcatheter.¿ the same prowler select plus microcatheter was used to place the two stents that were finally placed in the patient.The prowler select plus microcatheter was used throughout the procedure and will be returned with the enterprise stent.The reported issue did not result in any procedure delay, nor any harm to the patient.The procedure was continued with the use of the competitor stents.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.0mm x 23mm enterprise® 2 vascular reconstruction device and the concomitant 150cm x 5cm prowler select plus microcatheter were received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.All components were received in good condition.Further inspection was performed under a microscope.The delivery wire was inspected along its entire length, and no damages were found.The stent component was found still inside the introducer.The stent was observed in good condition, with no structural damage (i.E., no broken struts, no kinks).Some residues of dried saline solution were found inside the introducer.The functional test was performed.The concomitant prowler select plus was flushed using a lab sample syringe.After that, the 4.0mm x 23mm enterprise® 2 vascular reconstruction device was introduced, and it was advanced.There was no resistance / friction was felt during the advancement.The stent exited out from the distal tip of the microcatheter without difficulties.As the functional test was performed without issues, the reported impeded condition encountered during the procedure could not be confirmed.However, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the laboratory during the analysis.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7091646.The history record indicates 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.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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the complaint product and the concomitant microcatheter that was used throughout the procedure were received in the product analysis lab on 09-feb-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 ; 303552-689
• MDR Report Key: 16036099
• MDR Text Key: 308554201
• Report Number: 3008114965-2022-00852
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC402312
• Device Lot Number: 7091646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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: GS 90, 80 CM, STRAIGHT, DISTAL; HYBRID 1214D GUIDEWIRE (BALT); MICROCATHETER; MIRAGE¿ 0.008" HYDROPHILIC GUIDEWIRE (MEDTRONIC); SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION)
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 85 KG