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

Catalog Number ENCR402312

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Transient Ischemic Attack (2109); Coma (2417); Thromboembolism (2654)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.[conclusion]: the healthcare professional reported that an intra-procedure thrombus occurred during a vascular stent placement procedure performed on the 58-year-old female patient who suffered from basilar artery stenosis.The patient underwent stent dilation for intracranial stenosis.During the procedure, a 4mm x 23mm enterprise 2 stent (encr402312 / 7107635) was placed from the right posterior cerebral artery to the basilar artery.When the stent was fully opened, severe ischemia occurred in the stent, and the entire posterior cerebral artery was not visualized.Since the stent had been completely released and could not be removed, only medications could be administered for the endovascular treatment.Finally, the distal end of the vessel was still not visualized, and the procedure was deemed completed.It was reported that the procedure was delayed for approximately one (1) hour.At the time of the complaint initiation, the patient was still in a coma.Procedural imaging was included in the complaint for review.The procedural image included in the complaint was reviewed by senior medical affairs director ¿ dr.(b)(6), on (b)(6) 2022.The assessment reads as follows: the description provided highlights a problem with an enterprise stent in the basilar artery.The occurrence of clot in a stent is not uncommon but obviously an unwanted complication.There is no description of the pre-operative treatment with dual antiplatelet medication, nor is mentioned if heparin was administered.The reason for the narrowing of the basilar artery (vasospasm, icad, dissection) is not clear from the description.Based on the single image that is provided, the enterprise looks opened, the distal markers are visible.Clotting in this situation can be secondary to numerous causes such as: 1) no premedication, 2) inadequate response to premedication, 3) heparin induced thormocytopenia, 4) patient related coagulation disturbance, 5) refractory icad with stent narrowing, 6) cheese-grating of a soft plaque, 7) platelet adherence to the stent or 8) other causes.A distinction cannot be made on the basis of the available information.If additional information is provided at a later date the review can be reopened and assessed for its impact on the above analysis.Physician name and date reviewed: (b)(6) md, (b)(6) 2022 based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7107635.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Stenosis of stented segment is a well-known potential adverse event following stent implantation and is listed in the enterprise 2 instructions for use (ifu) as such.The act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation.The enterprise 2 vascular reconstruction device (vrd) is intended for use with occlusive devices in the treatment of intracranial aneurysms.It is not intended for use as a stand-alone device, i.E., without subsequent coil embolization of the aneurysm.This stent was used off-label for the treatment of an intracranial basilar artery stenosis.Since the cerebral thrombosis required medical intervention, had led to prolongation of the surgery and appears to have led to the comatose state of the patient, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ there is no indication that the enterprise malfunctioned or that the event is related to the device design or manufacturing process.Based on the review of the manufacturing documentation, 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 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 an intra-procedure thrombus occurred during a vascular stent placement procedure performed on the 58-year-old female patient who suffered from basilar artery stenosis.The patient underwent stent dilation for intracranial stenosis.During the procedure, a 4mm x 23mm enterprise 2 stent (encr402312 / 7107635) was placed from the right posterior cerebral artery to the basilar artery.When the stent was fully opened, severe ischemia occurred in the stent, and the entire posterior cerebral artery was not visualized.Since the stent had been completely released and could not be removed, only medications could be administered for the endovascular treatment.Finally, the distal end of the vessel was still not visualized, and the procedure was deemed completed.It was reported that the procedure was delayed for approximately one (1) hour.At the time of the complaint initiation, the patient was still in a coma.Procedural imaging was included in the complaint for review.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information and a correction on the patient info received on (b)(6) 2022.[additional information]: on (b)(6) 2022, additional information was received.The information contains a correction on the patient¿s age and gender and indicated that the 56-year-old male patient has regained consciousness and is no longer in a coma.The patient was reported to be in a coma for a duration of two (2) days.The medication administered to address the intra-procedure thrombus was tirofiban; the dosage was not included.It was unknown if the patient was prescribed medication before the procedure.The information indicated that the issue was not related to the distal end of the vessel not being visualized due to the thrombus.There was no issue associated with the enterprise stent during the procedure.The concomitant microcatheter used was a 150cm x 5cm, 2 markers prowler select plus microcatheter (606s255x).The physician deemed the 1-hour prolongation clinically significant because of the thrombolysis intervention with the administration of tirofiban.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.A.2: patient age at the time of event is 56.It was originally reported as 58.A.3: gender: male.It was originally reported as female.

• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 15821077
• MDR Text Key: 303901332
• Report Number: 3008114965-2022-00757
• 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
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 7107635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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 Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male