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

Catalog Number ENCR402312

Device Problem Failure to Advance (2524)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted coil embolization procedure that was targeting an aneurysm on the a1 segment of the left anterior cerebral artery, after angiography was completed and access was established under the road map, the concomitant microcatheter (unspecified brand) was delivered to the target site, the 4mm x 23mm enterprise 2 stent (encr402312 / (b)(6)) was delivered to the target site.The physician released the stent slowly but encountered resistance after ½ of the stent was released.The physician attempted to deliver the stent again, resistance was significant.The physician attempted to retract the stent, but the stent was unable to be withdrawn.The microcatheter and the stent were removed from the patient; the physician switched to new devices to complete the procedure.The procedure was prolonged by approximately 25 minutes.There was no report of any negative patient impact.A photo of the device was included in the complaint.On 04-dec-2023, additional information was received.The information indicated that the patient is a 53-year-old female with no medical history.A continuous flush had been maintained through the microcatheter.When the stent was removed from the patient, it was still on the delivery wire.The stent / stent delivery system did not appear damaged.The replacement stent was another 4mm x 23mm enterprise 2 stent (encr402312).The replacement microcatheter was the same brand as the original microcatheter (brand of microcatheter not specified).The information confirmed there was no negative patient impact.The physician did not consider the 25-minute procedure extension to be clinically significant.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier and date of birth were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: 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.The product analysis team reviewed the photo included in the complaint.The review is documented below.[photo review]: the photo included in the complaint shows the enterprise system inside the microcatheter with what seems to be residues of dried blood that have adhered to one of the struts and a dried blood clot coming out of the microcatheter tip.The stent component is partially out of the introducer with the delivery wire tip still connected to it; however, it cannot be ascertained if the rest of the delivery wire is connected to the stent as it remains inside the microcatheter.No appearance of damage is observed on the enterprise system components.The issue reported cannot be evaluated based on the photo provided.Functional test will determine possible contributing factors once the device is returned for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028718.The history record indicates 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.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.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.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 product was received in the product analysis lab on 09-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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 the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4mm x 23mm enterprise 2 stent was received contained in the decontamination pouch.Visual inspection was performed and the delivery system was noted to be attached to a non-j&j microcatheter.The stent was noted to be partially outside the tip of the catheter, and it was noted to remain attached to the delivery system.A dried clot remained in the struts of the stent.No other damages or abnormalities were noted in the device.These conditions are consistent with the damages noted in the photo that was included in the complaint.The delivery system was tried to be removed from the non-j&j microcatheter, but strong resistance was felt.Then, the system was tried to be pushed forward, but it was impossible; the enterprise system was not moving.The issue reported regarding the stent component being impeded in the microcatheter was confirmed based on the findings.The dried clot observed suggests that an adequate flush was not maintained, resulting in resistance that could have led to the strong resistance felt during the advancement of the enterprise system.It could be reasonably suggested that the damages noted in the non-j&j microcatheter are the result of the difficulties experienced during the withdrawal of the stent as it became impeded in the microcatheter.With the limited information available, the root cause of the failure mode observed remains inconclusive; however, there is no indication that the issue reported in the complaint results from 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 8028718.The history record indicates 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.It should be noted that product failure could be caused by multiple factors.The instruction for use (ifu) contains the following recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.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.The cerenovus enterprise vascular reconstruction device and delivery system is designed for use under fluoroscopy with the prowler® select¿ plus infusion catheter, (a 0.021" inner diameter, 5 cm distal length infusion catheter manufactured by cerenovus).Caution: compatibility with other infusion catheters has not been established.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.

• 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): CERENOVUS, INC.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18332955
• MDR Text Key: 330959417
• Report Number: 3008114965-2023-00900
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 8028718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian