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 03/10/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31135803) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.Intracranial 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 factors, including a severe baseline stroke (nihss score of 19), advanced age of 84, intravenous tissue plasminogen activator (tpa) administration at the time of stroke presentation, and comorbidities of atrial fibrillation and hypertension, may have contributed to the event of an intracranial hemorrhage.However, the event of an intracranial hemorrhage was assessed by the pi as possibly 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.Based on this information and the assessment of the pi, 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.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 event was reported via the excellent study, the 84-year-old male patient with a history of atrial fibrillation and hypertension, presented with a witnessed stroke on (b)(6) 2024 at 20:10 hour.The patient was presented to the treating hospital on the same day at 23:30, where computed tomography (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 ¿cardioembolic.¿ the patient¿s baseline nih stroke scale (nihss) score was 19 and modified rankin scale score (mrs) score was ¿0-no symptoms.¿.On (b)(6) 2024, the patient underwent an endovascular mechanical thrombectomy using a132cm embovac 71 aspiration catheter (ic71132ca / 31135803) for an occlusion at the m1 segment of the left middle cerebral artery (mca).The pre-pass modified thrombolysis in cerebral infarction (mtici) score was 0.The 1st pass was made using the direct contact aspiration device alone, which resulted in an mtici score of 0 with no clot retrieval.The 2nd pass was made using a 4mm x 41mm trevo nxt¿ retriever (stryker), resulted in an mtici score of 0 with clot retrieval in the stent retriever.The third pass was made using the direct contact aspiration device alone, which resulted in a mtici score of 2c with clot retrieval in the stent retriever.During the procedure, a guidewire (unspecified brand), a trevo trak¿ 21 microcatheter (stryker), a flowgate2¿ balloon guide catheter (stryker), and a sofia¿ intermediate catheter (microvention) were also used.It is unknown if there were any study device deficiencies during the procedure.The patient¿s 24-hour post-procedure nihss score was 10.On 10-mar-2024, the patient experienced a subarachnoid hemorrhage in the left basal ganglia.The principal investigator (pi) it is unknown if there were any study device deficiencies during the procedure.The patient¿s 24-hour post-procedure nihss score was 10.On 18-mar-2024, the patient was discharged to a rehabilitation center with a nihss score of 3 and a mrs score of ¿2-slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.¿ on 04-apr-2024, additional information was received from the excellent clinical study team with the responses from the interventionalist (principal investigator).Per the information, the reported adverse event is a small intracranial bleed (icb) at the basal ganglia next to the position of the aspiration, it was not a subarachnoid hemorrhage (sah).There was no device performance issue related to the embovac itself.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the modified information received on 07-may-2024.[additional & modified information]: per modified information received on 07-may-2024, the severity of the adverse event ¿subarachnoid hemorrhage in the left basal ganglia¿ was updated from ¿moderate¿ to ¿mild.¿.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: 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 ; 303552-689
• MDR Report Key: 19071851
• MDR Text Key: 339722940
• Report Number: 3008114965-2024-00344
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• 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
• Date Manufacturer Received: 03/22/2024
• 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: 4MM X 41MM TREVO NXT¿ RETRIEVER (STRYKER); FLOWGATE2¿ BALLOON GUIDE CATHETER (STRYKER); GUIDEWIRE (UNSPECIFIED BRAND); SOFIA¿ INTERMEDIATE CATHETER (MICROVENTION); TREVO TRAK¿ 21 MICROCATHETER (STRYKER)
• Patient Outcome(s): Life Threatening
• Patient Age: 84 YR
• Patient Sex: Male