MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401612

Device Problem Failure to Advance (2524)

Patient Problem Extravasation (1842)

Event Date 03/30/2024

Event Type  Injury  

Event Description

The healthcare professional reported that during an angioplasty procedure, the 4mm x 16mm enterprise 2 vascular reconstruction device (encr401612 / 8582195) was impeded at the distal end of the concomitant 150cm x 5cm prowler select plus microcatheter (606s255x / 31093250) and could not pass through the microcatheter.The physician removed the stent and the microcatheter from the patient and tried to deliver the stent into the microcatheter in vitro, the stent could not pass through the microcatheter.The physician then attempted to use the same microcatheter to deliver the same stent in the patient, but the stent was impeded at the distal end of the microcatheter and could not pass through.The physician then removed both devices from the patient.It was then observed via imaging that the basilar artery was bleeding.The physician gave corresponding treatment with hemostatic medication and terminated the procedure.The patient was admitted into the intensive care unit (icu).The procedure was prolonged by approximately 30 minutes.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, 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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8582195.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Stent-impediment in microcatheter with loss of cerebral target position in the intracranial vasculature will require re-accessing the target site with increased potential for vessel trauma, vessel spasm, or ischemia/infarct.In this case, the target site was not re-accessed due a basilar artery bleed found ¿under imaging.¿ the events may have contributed to the vessel extravasation; the severity/impact of the event is unknown.In addition, hemostatic medication was required, and the procedure was prolonged by 30 minutes before ultimately being terminated, resulting in absence of treatment for the patient.The patient was admitted to the intensive care unit (icu) and will require prolonged hospitalization.Based on this information, this event meets us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00384.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 include the additional event information received on 29-apr-2024.[additional information]: on 29-apr-2024, additional information was received.Per the information, the procedure was targeting the basilar artery.There was no excessive vessel tortuosity or acute bends in the target vessel.The information indicated that the patient has been discharged from the hospital to a rehabilitation center.The residual symptom / deficit from the reported bleed is limb movement disorder.The patient¿s hospitalization was prolonged by 7 days.The information indicated that the bleed occurred after the physician took out the microcatheter and the stent to prepare for pre-release radiography.The bleed was at the location where the tip of the microcatheter was placed.The information indicated that the cause of the bleed may be due to the stent tip being pushed repeatedly in attempt to release the stent and the tip was against the vessel wall.The patient was administered tirofiban 6 ml/hr via sustained pump.The reported ¿corresponding treatment¿ provided to the patient to address the bleed was 30mg bolus intravenous (iv) protamine; protamine was the hemostatic medication administered to the patient.The procedure was confirmed as not completed.The information indicated that when the stent was removed from the patient, it was still on the delivery wire.There was no damage on the stent / stent delivery system when it was removed from the patient.The physician did consider the 30-minute procedure extension to be clinically significant; it was for effective neutralization of anticoagulant with protamine.Updated sections: b.4, e.1, e.3, g.3, g.6, h.2, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00383 and 3008114965-2024-00384.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 07-may-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: 3008114965-2024-00383 and 3008114965-2024-00384.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 4mm x 16mm enterprise 2 vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the delivery wire remained inside the concomitant 150cm x 5cm prowler select plus microcatheter.The introducer component was not returned for evaluation.The concomitant 150cm x 5cm prowler select plus microcatheter was flushed in order to try and remove the enterprise stent; however, strong resistance was felt.The microcatheter was dissected at different points; the stent was found inside, also residues of dried blood/biological material were found in the inner lumen.The delivery system was not able to be removed.The issue reported in the complaint that the enterprise device became impeded in the microcatheter was confirmed based on the condition of the returned device; however, with the information available and the evidence obtained from the returned devices, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.It is suggested that the flush may have not been adequate during the procedure, without an adequate flush, issues such as resistance between the delivery wire and the microcatheter can arise.Other circumstances or issues may occur while using the device that could not be replicated during the analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8582195.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 recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00383 and 3008114965-2024-00384.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 4MMX16MM
• 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: 19140686
• MDR Text Key: 340560246
• Report Number: 3008114965-2024-00383
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401612
• Device Lot Number: 8582195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male