MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EMBOGUARD 87, 95 CM; EMBOGUARD BALLOON GUIDE CATHETER

Model Number BG8795U

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 05/25/2023

Event Type  Injury  

Event Description

As reported via the excellent study (cnv_2017_02), a 58-year-old male (subject 01282-026) with a history of atrial fibrillation, congestive heart failure, diabetes, and actively smoking presented with a witnessed stroke on (b)(6) 2023.The patient was presented to the treating hospital on the same day.Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was cardioembolic.The patient¿s baseline nihss score was 18 and an mrs score of 0.The patient underwent an endovascular mechanical thrombectomy on 25-may-2023 using an ic 71, 132 cm, ce, asp.Ind (ic71132ca/ 30927534) device for occlusion at the m1 segment of the right middle cerebral artery (mca).The pre-pass mtici score was 0.The 1st pass resulted in an mtici score of 3 with clot retrieval in the aspirate.During the procedure, a guidewire was used, but the brand was not specified.In addition, a 0.050 axs microcatheter and an emboguard balloon guide catheter were also used.There were no reported intraoperative study device deficiencies.On the same day as the procedure, the patient experienced a subarachnoid hemorrhage.The principal investigator (pi) assessed this event as mild, not serious, and possibly related to the study device and primary surgical procedure.This event was not treated.The patient recovered and the event was resolved on 26-may-2023.The patient¿s 24-hour post-procedure nihss score was 10.The patient was discharged to another hospital on(b)(6) 2023 with an nihss score of 8 and an mrs score of 4.Additional information was received on (b)(6) 2023.Summary of relevant information provided: the question ¿if event is both serious and device or procedure related, in the opinion of the investigator and in accordance with the list of expected events in the protocol and instructions for use, is the adverse event:¿ was updated to ¿n/a (does not meet above criteria).¿.

Manufacturer Narrative

Product complaint # : (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section a1.Patient identifier: (b)(6).Section d3 ¿ the product catalog and lot numbers were not reported; udi unavailable.Section e1.Initial reporter phone: (b)(6).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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00460 and 3008114965-2023-00461.

Manufacturer Narrative

(b)(4).Updated sections on this medwatch: b4, d1, d2a, d2b, d4, g3, g4, h2, h6 and h10.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Subarachnoid hemorrhage is a known complication associated with both the use of the embovac device and the emboguard device and is mentioned in the instructions for use (ifu) as such for both devices.Per the principal investigator¿s assessment, the adverse event of ¿subarachnoid hemorrhage¿ was possibly related to the use of the study device and the primary surgical procedure.Therefore, this event does meet 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.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: EMBOGUARD 87, 95 CM
• Type of Device: EMBOGUARD BALLOON GUIDE CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; block 3 ballybritt business pa; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17256635
• MDR Text Key: 318556289
• Report Number: 3008114965-2023-00461
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704082743
• UDI-Public: 10886704082743
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K212340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BG8795U
• Device Catalogue Number: BG8795U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 0.050 AXS MICROCATHETER.; IC 71, 132 CM, CE, ASP. IND.; UNSPECIFIED GUIDEWIRE.
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian