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 Problems Intracranial Hemorrhage (1891); Ischemia Stroke (4418)

Event Date 11/25/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device was discarded, therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31093998 number, and no non-conformances related to the malfunction were identified.Cerebral hemorrhage and cerebral infarction are both known potential complications associated with the use of the embovac device and are listed in the instructions for use (ifu) as such.There were no alleged quality issues related to the device used, as the device performed as intended.Although the pi assessed the event as not related to the large bore catheter and not related to the primary surgical procedure, the event occurred the same day as the devices use, therefore, the correlation between used device to the event cannot be ruled out at this time.Since a cerebral hemorrhage and a cerebral infarction are considered serious injuries, this event does meet us fda reporting criteria under criteria 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.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.

Event Description

As reported via the excellent study (b)(6) a 75-year-old male (subject (b)(6)) with a medical history of hyperlipidemia and hypertension, presented with an unwitnessed wake up stroke.Last time seen well was on (b)(6) 2023 at 23:00.Symptoms were first observed on (b)(6) 2023 at 06:00.The patient was presented to the treating hospital on (b)(6) 2023 at 07:20.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 19 and an mrs score of ¿0-no symptoms.¿ the patient underwent an endovascular mechanical thrombectomy on (b)(6) 2023 using an embovac ic 71, 132 cm, ce, asp.Ind.(ic71132ca/ 31093998) device for an occlusion at the m1 segment of the right middle cerebral artery (mca).The pre-pass mtici score was 0.The 1st pass was done using a direct contact aspiration device alone, resulting in a mtici score of 2b, with clot retrieval in the aspirate.During the procedure, a guidewire was used, but the brand was not specified.In addition, a 0.021 trevo microcatheter, and an 8 optimo balloon guide catheter were also used.It is unknown if there were any intraoperative device deficiencies.On (b)(6) 2023, the same day as the procedure, the patient experienced the adverse event of a ¿m1 hemorrhagic cerebral infarction,¿ which became known to the site on the same day and sponsor on (b)(6) 2023.The principal investigator (pi) assessed this event as not serious, mild in severity, and as not related to the study device, not related the large bore catheter, and not related to the primary surgical procedure.This event was not medically treated, and the outcome is recorded as ¿recovered/resolved,¿ with an end date of (b)(6) 2023.The patient¿s 24-hour post-procedure nihss score was 17.On (b)(6) 2023, the patient¿s 7-day post-procedural assessments were performed, which resulted with a nihss score of 8 and a mrs score of ¿4-moderately severe disability.Unable to walk without assistance and unable to attend to own bodily needs without assistance.¿ the patient¿s discharge information has not yet been entered into the clinical database at the time of this review.

• 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: 18312863
• MDR Text Key: 330328781
• Report Number: 3008114965-2023-00935
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 31093998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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: OPTIMO 8F BALLOON CATHETER; TREVO 0.021" MICROCATHETER; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian