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

Catalog Number ENCR402312

Device Problems Premature Activation (1484); Activation Failure (3270)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).Information regarding patient identifier, date of birth, and weight were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section e.1: initial reporter facility name: the general hospital of the southern theater command of the people's liberation army of china.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 shows the stent already detached from the delivery system.The stent remained inside the hub of the microcatheter.The rest of the device is not shown / observed in the photo and no further damages could be noted.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8484769.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.The issue regarding a stent prematurely released was confirmed since the stent was noted already detached from the unit, however, the issue regarding incomplete expansion cannot be evaluated.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.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.

Event Description

The healthcare professional reported that during a thrombectomy and angioplasty procedure, after the thrombus was removed with a competitor stent, a 4mm x 23mm enterprise 2 (encr402312 / 8484769) was placed in the target site via a 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) and the physician attempted to release the stent.The physician observed that the distal markers of the stent were converged and could not be opened.The stent was retracted but it was observed to be prematurely released in the proximal section of the microcatheter; the stent component was prematurely separated from the delivery wire.The physician removed the stent, the microcatheter and the 125cm large bore catheter (ic71125ug / lot# unknown) from the patient.The large bore catheter was observed to be kinked; it was reported that prior to use, it was inspected by the physician and was found to be in good condition.The physician replaced all three devices to complete the procedure, which was reportedly prolonged by approximately 10 minutes.There was no report of any negative patient impact.A photo of a device was included in the complaint.On 14-mar-2024, additional information was received.Per the information, the patient is a 60-year-old male.The target vessel was the middle cerebral artery (mca) / the enterprise stent was targeting the mca.There were no vessel nor aneurysm factors that may have contributed to the reported incomplete expansion.There was no evidence of obstructed blood flow due to the reported issue.The temperature indicator label on the inner pouch of the stent was checked and found to be within acceptable criteria.The information indicated that there had been resistance during the advancement of the stent in the guiding catheter; the replacement stent was another 4mm x 23mm enterprise 2 (encr402312) and the replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter (606s255x).The embovac large bore catheter was replaced with another device of a different brand.The information confirmed there was no negative patient impact.The physician did not consider the 10-minute procedure extension to be clinically significant.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation 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.It was noted that only the stent was returned for evaluation; it was returned detached in the concomitant prowler select plus microcatheter as observed in the photo included in the complaint.The stent was removed from the microcatheter's hub and then inspected under a microscope, and no damages were found (i.E., no kinks, no bends, or broken struts).Both distal ends can be noted completely flared.The delivery wire was subjected to dimensional analysis and all measurements were found to be within specification, including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The issue documented in the complaint regarding a stent being prematurely released in the proximal section of the microcatheter was confirmed since the stent was found detached inside the microcatheter's hub; however, this condition suggests that the enterprise introducer was not fully seated in the hub of the microcatheter, causing the stent to expand in the microcatheter's hub, causing the resistance and resulting in the stent component being unable to advance further, where push/pull force was applied sufficiently to disengage the stent from the delivery wire.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.Based on this, the customer complaint was confirmed.The issue documented in the complaint regarding the stent not being fully opened or expanded was not confirmed since the stent was found fully expanded during the analysis.It is possible that the marker bands may have converged together but apposed to the vessel wall.There is no indication that the issues reported in the complaint result 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 8484769.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 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.¿ maintain adequate stent length (approximately 5mm) on each side of the aneurysm neck to ensure appropriate neck coverage.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 product analysis lab received the complaint device on 10-apr-2024.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): CERENOVUS, INC.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18975971
• MDR Text Key: 339272950
• Report Number: 3008114965-2024-00300
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 8484769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2023
• 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: 125CM LARGE BORE 71 CATHETER.; PROWLER SELECT PLUS 150/5CM.
• Patient Age: 60 YR
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian