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 10/20/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was 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 (31041010) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The event of ¿right mca hemorrhagic infarction¿ was discussed with the medical safety officer (mso) on 17-nov-2023.Per the mso, the possibility of a hemorrhage or an occlusion formation as a result of trauma from the procedure site cannot be absolutely ruled out.Given the 2-day interval between the procedure and the reported event, as well as the location of the procedure and event, the adverse event of ¿right mca hemorrhagic infarction¿ cannot be ruled out completely, regardless of the assessment given by the pi.Cerebral hemorrhage and cerebral infarction are both known potential complications associated with the use of the embotrap iii and embovac devices and are listed in the instructions for use (ifu) as such.There were no alleged quality issues related to the devices used, as the devices performed as intended.Although the pi assessed the event as unrelated to the study device, unrelated to the large bore catheter, and unrelated to the surgical procedure, the event occurred at the same location as the use of the devices, with a temporal gap of just two days.As such, the relationship between the devices and the adverse event of ¿right mca hemorrhagic infarction¿ cannot be ruled out completely.Based on this information and the assessment of the mso, this event will be conservatively reported to the us fda reporting 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.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.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 is one of 2 products involved with the reported complaint.The associated manufacturer report number is: 3011370111-2023-00192.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 92-year-old male patient with no medical history presented with a witnessed stroke on (b)(6) 2023 at 18:30 hour.The patient was presented to the treating hospital on the same day at 19:15 hour.Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was cardioembolic.The patient presented a baseline nih stroke scale (nihss) score of 33 and a modified rankin scale (mrs) score of ¿3-moderate disability.Requires some help, but able to walk without assistance.¿ on (b)(6) 2023, the patient underwent an endovascular mechanical thrombectomy procedure using a 5mm x 37mm embotrap iii revascularization device (et309537 / 23e007av) and a 132cm embovac 71 aspiration catheter (ic71132ca / 31041010).The pre-pass modified treatment in cerebral infarction (mtici) score was 0.The first pass was made via a rebar¿ 18 microcatheter (medtronic) that targeted an occlusion at the right carotid terminus resulted in an mtici score of 0 with clot retrieval in the aspirate.Due to difficulty accessing/crossing the clot, a 2nd pass was done using a direct contact aspiration device alone, which resulted in a mtici score of 0, with clot retrieval in the aspirate.Due to difficulty accessing/crossing the clot, a 3rd pass was done using a 40mm solitaire¿ revascularization device (medtronic) which resulted in a mtici score of 2a, with clot retrieval in the aspirate.Due to persistent clot, a 4th pass was made using the same embotrap iii device, which resulted in a mtici score of 2b, with clot retrieval in the aspirate.The first three passes targeted the occlusion in the right carotid terminus, the fourth pass targeted the occlusion in the right m2 segment of the middle cerebral artery (mca).The 24-hour post-procedure nihss score was 35.On (b)(6) 2023, the patient experienced a right middle cerebral artery (mca) hemorrhagic infarction.The principal investigator (pi) assessed the event as not serious, mild in severity, and as not related to the embotrap iii study device, not related to the large bore catheter, and not related to the primary surgical procedure.The event was treated with medication, and the outcome is recorded as ¿recovering/resolving¿ with no end date listed.On (b)(6) 2023, the patient¿s seven-day post-procedural assessments were done with the following scores: nihss score of 33 and a modified rankin scale (mrs) score of ¿5-severe disability.Bedridden, incontinent, and requiring constant nursing care and attention.¿ the patient¿s discharge information has not been entered into the case report form (crf) at the time of this review.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 12-dec-2023.[additional information]: on 12-dec-2023, additional information was received.The information indicated that the right mca hemorrhagic infarction experienced by the patient 2-day post-procedure is the same site as where the procedure was performed.There was no device performance issues related to neither the embotrap iii device nor the embovac balloon catheter.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2023-00192 and 3008114965-2023-00875.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 07-dec-2023.[additional information]: modified information was received on 07-dec-2023.The modified information is related to the outcome of the reported adverse event ¿right mca hemorrhagic infarction¿ and the site awareness date of the event.The outcome has been updated from ¿recovering / resolving¿ to ¿not recovered / not resolved.¿ the site awareness date has been updated from "20 oct 2023" => "19 oct 2023".This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2023-00192 and 3008114965-2023-00875.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the modified information received on 08-apr-2024.[modified information]: on 08-apr-2024, modified information was received.The modified information is related to the severity of the adverse event ¿right mca hemorrhagic infarction.¿ severity was updated from ¿mild¿ to ¿moderate.¿ this is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2023-00192.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 07-feb-2024.[additional information]: on 07-feb-2024, additional information was received from the excellent study clinical team.Per the information, the event was attributed to the natural progression of the index stroke.In addition, there was vessel trauma associated with the event.This additional information has been reviewed.Since there was vessel trauma associated with the event, the used devices cannot be ruled out as a contributing factor.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2023-00192 and 3008114965-2023-00875.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: 18212151
• MDR Text Key: 329042569
• Report Number: 3008114965-2023-00875
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/09/2024

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: 31041010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/07/2023; 12/12/2023; 02/07/2024; 04/08/2024
• Supplement Dates FDA Received: 12/11/2023; 12/13/2023; 02/07/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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: 8FR OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL); EMBOTRAP III 5 MM X 37 MM; GUIDEWIRE (UNSPECIFIED BRAND); REBAR¿ 18 MICROCATHETER (MEDTRONIC); TREVO TRAK 21 MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian