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 11/11/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Section a1.Patient identifier: (b)(6).The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30898467 number, and no non-conformances related to the malfunction were identified.Subarachnoid hemorrhage is a known potential complication associated with the use of the embotrap iii and embovac devices and is listed in the instructions for use (ifu) as such for both devices.There were no alleged quality issues related to the devices used, as the device performed as intended.The pi assessed the event as possibly related to the embotrap iii study device, not related to the embovac large bore catheter, and possibly related to the surgical procedure.Since the event occurred the day after the procedure, the relationship between both devices and the adverse event of ¿subarachnoid hemorrhage,¿ cannot be ruled out completely.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.Per the additional information received on 28-nov-2023, despite the event being assessed as not serious and mild in severity, more than one third of sah survivors have major neurologic deficits.Cognitive deficits are present even in many patients considered to have a good outcome.Therefore, the event remains reportable to the usfda, as the event meets the definition of a serious injury and the correlating relationship of the event to the used device cannot be ruled out completely.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.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2023-00203 and 3008114965-2023-00921.

Event Description

It has been reported by the excellent clinical team that a technical issue is preventing automatic alerts from being sent by the normal data entry triggers.A report was received on 19-nov-2023 summarizing changes and entries to the registry.The following information summary was taken from the clinical database, the crf, for the most updated information: as reported via the excellent study ((b)(6)), a (b)(6) year-old female (subject (b)(6)) with a medical history of congestive heart failure (chf), hyperlipidemia, and hypertension, presented with an unwitnessed wake-up stroke.Last time seen well was on (b)(6) 2023, time unknown.Symptoms were first observed on (b)(6) 2023 at 10:00.The patient was presented to the treating hospital on (b)(6) 2023 at 11:53, where mri imaging confirmed an ischemic stroke.Intravenous tissue plasminogen activator (tpa) was not administered.The suspected origin of the embolism was ¿cardioembolic.¿ the patient¿s baseline nihss score was 21 and modified rankin scale score (mrs) score was ¿2-slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.¿ on (b)(6) 2023, the patient underwent an endovascular mechanical thrombectomy using an embotrap iii 6.5 mm x 45 mm (et309645/23e168av) and an ic 71, 132 cm, ce, asp.Ind.(ic71132ca / 30898467) for occlusions at the right carotid t, right internal carotid artery (ica), and m2 segment of the right middle cerebral artery (mca).The pre-procedure tici score was 0.The first three passes were done using a direct contact aspiration device alone and resulted in a mtici score of 1 for the carotid t occlusion and a mtici score of 0 for the ica occlusion, with clot retrieval in the aspirate for the 2nd pass only.Due to difficulty accessing/crossing the clot, the 4th, 5th, and 6th passes were made using the embotrap iii device and resulted in a mtici score of 2b for the ica occlusion, with clot retrieval in the aspirate for the 5th pass only.Due to ¿treating non-target occlusion location,¿ the 7th and 8th passes were made using a solitaire 4 mm x 40 mm and resulted in a mtici score of 2c for the mca occlusion, with clot retrieval in the stent retriever for both passes.During the procedure, a guidewire was used, but the brand was not specified.A 0.021 trevo microcatheter, a 0.070 sofia plus intermediate catheter, and an 8 optimo balloon guide catheter were also used.It is unknown if there were any device deficiencies during the procedure.The patient¿s 24-hour post-procedure nihss score was 18.On (b)(6) 2023, the patient experienced the event of a ¿subarachnoid hemorrhage,¿ which was made 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 possibly related to the embotrap iii study device, unrelated to the large bore catheter, and possibly related to the primary surgical procedure.The event was not medically treated.The outcome is recorded as ¿recovering/resolving¿ with no end date listed.On (b)(6) 2023, the patient was seen for the seven-day post-procedure assessments, which resulted with a nihss score of 12 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 was not made available at the time of this review.Additional information from the excellent clinical team was received on 28-nov-2023.Summary: per the information, the adverse event of ¿subarachnoid hemorrhage¿ was not serious, and thus the hospitalization was not prolonged.As the severity of the event was mild, it is uncertain if this will lead to a new stroke.The outcome was said to be, the ¿subject is recovering and per the nihss trend, the subject¿s neurological status appears to be improving.¿.

• 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: 18259761
• MDR Text Key: 329673677
• Report Number: 3008114965-2023-00921
• 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: 12/04/2023

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 Expiration Date: 01/31/2024
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30898467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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: EMBOTRAP III 6.5 MM X 45 MM; OPTIMO 8F BALLOON CATHETER; TREVO 0.021IN MICROCATHETER; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian