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

Catalog Number ENCR402312

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

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted aneurysm embolization procedure, a 4mm x 23mm enterprise 2 stent (encr402312 / 7599221) became impeded in the proximal portion of the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / 31014438) and could not be further advanced.The physician retracted the stent and observed that the delivery wire broke and a partial section remained in the microcatheter.The physician removed the microcatheter from the patient and switched to new devices to complete the procedure.The procedure was reportedly prolonged by about 10 minutes.There was no report of any negative patient impact.A photo was included in the complaint.On (b)(6) 2023, additional information was received.The information indicated that the patient is a 64-year-old female with a history of hypertension, diabetes and she had a sudden onset of severe headache that lasted for one hour before being admitted.The procedure was targeting a posterior communicating artery (pcoa) aneurysm.A continuous flush had been maintained through the microcatheter.There were no visible kinks or other damages observed on the microcatheter.Aside from the broken delivery wire, nothing unusual was noted on the stent component.The replacement stent was another 4mm x 23mm enterprise 2 stent of the same product code (encr402312) and the replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter (606s255x).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 patient identifier was 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]: one photo was included in the complaint; the stent was noted to be partially outside the introducer.No visible damages were noted on it.The delivery wire was noted to be broken in two and the distal portion was noted to be outside the introducer.No other damages were noted.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7599221.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The issue related to the delivery wire being impeded and broken was confirmed based on the broken condition observed.This broken condition may be the result of the delivery wire being reported as impeded.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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00571.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 01-sep-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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00570 and 3008114965-2023-00571.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.It was observed that the introducer contained the delivery wire and the stent.Microscopic inspection was performed.Under magnification, several stretched segments can be observed on the delivery wire tip segment.The tip of the introducer presented some fraying.A separation of the delivery wire tip segment from the rest of the device is observed.Crystallization was found within the introducer, mainly in the delivery wire segment proximal to the stent.The issue reported regarding the stent component being impeded in the microcatheter could not be evaluated through functional testing since the unfractured system must be still inside the introducer tube to perform the functional analysis.However, based on the observed condition of the returned device, the issue reported regarding a separated delivery wire was confirmed.The observed crystallization may be an indication of an insufficient flow volume during continuous flush, which can result in an increase in friction when maneuvering the stent delivery system.It is possible that in an effort to overcome this increased resistance, excessive force was inadvertently applied that ultimately led to the separation in the delivery wire.The fray damage noted on the introducer tip is likely the result of device handling for product return and is not considered to be a factor in the reported event.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the device.Based on this, the reported issue in the complaint was confirmed.(b)(6) medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7599221.The history record indicates this product was final inspection tested at (b)(6) 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) contains 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.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00570 and 3008114965-2023-00571.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: 17569376
• MDR Text Key: 321690395
• Report Number: 3008114965-2023-00570
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• 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: 7599221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• 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: PROWLER SELECT PLUS 150/5CM
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian