MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problems Premature Activation (1484); Retraction Problem (1536); Failure to Advance (2524); Material Twisted/Bent (2981)

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

Event Date 02/03/2024

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted endovascular embolization targeting an anterior communicating artery aneurysm, when ½ of the stent component of the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 8512180) was delivered to the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / 31135554), the stent was impeded in the microcatheter and could not be further advanced.After several making several unsuccessful attempts, the physician tried to retract the stent, but the stent was stuck in the microcatheter.The physician removed the microcatheter and the stent from the patient and replaced them with new devices to complete the procedure.The stent component was observed to have prematurely detached from the delivery wire; the delivery wire was observed kinked / bent.There was no report of any negative patient impact.A photo was included in the complaint.On 05-feb-2024, additional information was received.The information confirmed the target aneurysm was an anterior communicating artery aneurysm.A continuous flush had been maintained through the microcatheter.The replacement stent was another 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212) and the replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter (606s255x).The reported event did not result in any delay in the procedure; the information confirmed no negative patient impact.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity 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 photo included in the complaint of the stent was reviewed by the product analysis team.The review is documented below.[photo review]: one of the photos included in the complaint shows the stent component already detached from the unit.Due to the resolution being blurry, it cannot be determined if the stent component is damaged.However, both ends of the stent were observed to be flared.One kinked area was noted on the distal portion of the delivery wire.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8512180.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 issues regarding a stent being prematurely detached and a delivery wire being kinked were confirmed during the photo inspection, and based on these conditions the issues regarding impeding and withdrawal difficulty were also confirmed since these damages may be the result of the difficulties experienced during the procedure.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 is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00193.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 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 4.5mm x 22mm enterprise® vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent was already detached from the unit, and it was not returned for evaluation.The introducer was in good condition (i.E., no kinks, bends, nor elongations).The delivery wire was inspected under a microscope, and the distal coil was found kinked and with residues of dried saline solution on it.This condition is consistent with the damage seen in the photo included in the complaint.The delivery wire was subjected to dimensional analysis and all measurements were found to be within specifications, 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 regarding strong resistance while using the stent cannot be evaluated through a functional test since the stent was found already separated from the delivery system.The stent must be inside the introducer tube to perform the functional analysis.However, it is possible that in an effort to overcome this resistance felt, excessive force was inadvertently applied during the device advancement/withdrawal which ultimately led to the kinked condition found in the delivery wire.Based on this, the customer complaint was confirmed.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.The reported issue documented in the complaint regarding a stent being prematurely detached was confirmed since the stent was noted as already separated from the delivery system.However, the dimensional analysis performed showed no issues that could have resulted in the premature detachment of the stent.With the information available, the root cause of the failure encountered cannot be determined.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 enterprise device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8512180.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) does contain the following recommendation: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.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.Updated sections: b.4, 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: 3008114965-2024-00193.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 12-mar-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00192 and 3008114965-2024-00193.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: EU 4.5X22MM STENT 12 MM DW TIP
• 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: 18744420
• MDR Text Key: 336869614
• Report Number: 3008114965-2024-00192
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Device Lot Number: 8512180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• 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: PROWLER SELECT PLUS 150/5CM