MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 132 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number IC71132CA

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Section a1.Patient identifier: cnv_2017_02: 01037-165 the device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31135803 number, and no non-conformances related to the malfunction were identified.Subarachnoid hemorrhage is a known potential complication associated with the use of the embovac large bore catheter and is listed in the instructions for use (ifu) as such.There were no alleged quality issues related to the used device, as the device performed as intended.There may have been patient and pharmacological factors, including intravenous tissue plasminogen activator (tpa) administration at the time of stroke presentation, and comorbidities of hyperlipidemia and hypertension, that may have contributed to the event of a subarachnoid hemorrhage.However, the event of a subarachnoid hemorrhage was assessed by the pi as probably related to the large bore catheter and possibly related to the primary surgical procedure; therefore, the correlating relationship between the event and the embovac large bore catheter cannot be ruled out entirely.Additionally, the severity of the event/impact to the patient is unknown, as the patient¿s 7-day post-procedure neurological assessment shows worsening capacity for independent activities of daily living (adl), as seen by comparison to the patient¿s baseline mrs score, 0 to 2.As explained in the referenced literature article, more than one third of sah survivors live with major neurologic deficits; cognitive deficits are present even in many patients considered to have a good outcome.Based on this information and the assessment of the pi, 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.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.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.

Event Description

As reported via the excellent study (cnv_2017_02), a 61-year-old male (subject 01037-165) with a history of hyperlipidemia, hypertension, and active smoking, presented with a witnessed stroke on 27-mar-2024 at 12:30.The patient was presented to the treating hospital on the same day at 13:07, where ct imaging confirmed an ischemic stroke.Intravenous tissue plasminogen activator (tpa) was administered at the time of stroke presentation.The suspected origin of the embolism was ¿undetermined etiologies.¿ the patient¿s baseline nihss score was 11 and modified rankin scale score mrs score was ¿0-no symptoms.¿ on 27-mar-2024, the patient underwent an endovascular mechanical thrombectomy using an embovac ic 71, 132 cm, ce, asp.Ind.(ic71132ca/31135803) for an occlusion at the m2 segment of the right middle cerebral artery (mca).The pre-pass mtici score was 0.The 1st pass was made using direct contact aspiration device alone, which resulted in a mtici score of 0, with no clot retrieval.Due to persistent clot, the 2nd and 3rd passes were made using a trevo stent-retriever, which resulted in a mtici score of 3, with clot retrieval in the stent retriever for the 3rd pass only.During the procedure, a guidewire was used, but the brand was not specified.A 0.021 headway microcatheter, a 0.058 axs catalyst and a 0.055 sofia intermediate catheters, and an 8 flowgate2 balloon guide were also used.It is unknown if there were any study device deficiencies during the procedure.The patient was admitted to the intensive care unit (icu) on (b)(6) 2024.The patient¿s 24-hour post-procedure nihss score was 5.On 28-mar-2024, the patient experienced the event of ¿subarachnoid hemorrhage in the right sylvian fissure,¿ which was made known to the site and sponsor on 08-apr-2024.The principal investigator (pi) assessed this event as not serious, moderate in severity, and as unrelated to the embotrap iii study device (not used), probably related to the large bore catheter, and possibly related to the primary surgical procedure.The event was not medically treated.The outcome is recorded as ¿recovered/resolved,¿ with an end date of 03-apr-2024.On (b)(6) 2024, the patient was discharged home for self-care, with a nihss score of 2 and a mrs score of ¿2-slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.¿.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional/modified information was received on 07-may-2024.Summary: regarding the event of ¿subarachnoid hemorrhage in the right sylvian fissure,¿ the severity was updated from "moderate" to "mild." a supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: IC 71, 132 CM, CE, ASP. IND.
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; 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: 19163639
• MDR Text Key: 340840372
• Report Number: 3008114965-2024-00421
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191237
• 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: 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Device Lot Number: 31135803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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: FLOWGATE2¿ 8F BALLOON GUIDE CATHETER (STRYKER); GUIDEWIRE (UNSPECIFIED BRAND); HEADWAY® 21 MICROCATHETER (MICROVENTION)
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male