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

Catalog Number IC71132CA

Device Problem Material Twisted/Bent (2981)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported, from personal interaction, that an embovac (ic 71, 132 cm, ce, asp.Ind.) (product code: ic71132ca, lot 30767688) aspiration catheter was used in combination with an embotrap (product code & lot number unknown) revascularization device during a mechanical thrombectomy procedure to treat an acute ischemic stroke (ais) in the middle cerebral artery.Per the event description, the microcatheter (mc) and its wire were inserted into the patient and crossed the lesion.Then the embotrap (et) and the embovac (ev) were inserted.The embotrap was ¿pulled with aspirating by ev¿ and then these were retrieved together.During the second pass, there was an attempt to insert the embotrap device via the embovac device, but this attempt failed since there was a kink in the embovac device.The embovac was pulled out and the second pass was done with only the embotrap device, but the thrombus was not collected.The procedure was completed after achieving blood flow.A continuous flush was done, and the other concomitant device used is unknown.After the procedure was completed, bleeding was noticed.At the time of this review, there is no information available regarding the impact on the patient.Additional information received on (b)(6) 2023.Summary of the information provided: the information notes the patient was of male gender and he is currently in the hospital for cancer treatment (as of (b)(6) 2023).The bleeding had stopped, and no problems to the patient.No additional endovascular treatment has been planned because partial recanalization was achieved.The patient¿s hospitalization for cancer treatment will be continued.The physician¿s assessment of the event was that it was a minor/moderate and not serious event.This additional information did not require changes to the reportability determination because the relationship between the event and devices used cannot be ruled out; therefore, no changes were made.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Section h4.Device manufacture date: not available at time of report.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2023-00106.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, e1, e3, g3, g6, h2, h4, h6 and h10.Section b5: additional information was received on 07-aug-2023.Summary of the provided information: the information supplied the lot number (30767688) for the embovac device.Additionally, the following event description was provided: ¿concomitant mc (microcatheter) and gw (guidewire) were advanced through the clot, and embotrap and embovac were advanced to the clot.The embotrap trapped the clot and withdrawn from patient body together with the embovac while the aspiration was contined through out the retreival.Then the event (embovac was confirmed to be kinked) ocured.After the procedure, hemorhage was confirmed¿.Section e1.Initial reporter phone: (b)(6).The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30767688 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

Product complaint # (b)(4), updated sections on this medwatch: b4, g3, g6, h2 and h10.Complaint conclusion: it was reported, from personal interaction, that an embovac (ic 71, 132 cm, ce, asp.Ind.) (ic71132ca/ 30767688.) aspiration catheter was used in combination with an embotrap (product code & lot number unknown) revascularization device during a mechanical thrombectomy procedure to treat an acute ischemic stroke (ais) in the middle cerebral artery.Per the event description, the microcatheter (mc) and its wire were inserted into the patient and crossed the lesion.Then the embotrap (et) and the embovac (ev) were inserted.The embotrap was ¿pulled with aspirating by ev¿ and then these were retrieved together.During the second pass, there was an attempt to insert the embotrap device via the embovac device, but this attempt failed since there was a kink in the embovac device.The embovac was pulled out and the second pass was done with only the embotrap device, but the thrombus was not collected.The procedure was completed after achieving blood flow.A continuous flush was done, and the other concomitant device used is unknown.After the procedure was completed, bleeding was noticed.At the time of this review, there is no information available regarding the impact on the patient.Additional information received on 27-jul-2023.Summary of the information provided: the information notes the patient was of male gender and he is currently in the hospital for cancer treatment (as of 27-jul-2023).The bleeding had stopped, and no problems to the patient.No additional endovascular treatment has been planned because partial recanalization was achieved.The patient¿s hospitalization for cancer treatment will be continued.The physician¿s assessment of the event was that it was a minor/moderate and not serious event.This additional information did not require changes to the reportability determination because the relationship between the event and devices used cannot be ruled out; therefore, no changes were made.Additional information was received on (b)(6), 2023.Summary of the provided information: the information supplied the lot number (30767688) for the embovac device.This information was been updated in the initial review above.Additionally, the following event description was provided: ¿concomitant mc (microcatheter) and gw (guidewire) were advanced through the clot, and embotrap and embovac were advanced to the clot.The embotrap trapped the clot and withdrawn from patient body together with the embovac while the aspiration was contined through out the retreival.Then the event (embovac was confirmed to be kinked) ocured.After the procedure, hemorhage was confirmed¿.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30767688 number, and no non-conformances related to the malfunction were identified.Intracranial hemorrhage is a known potential adverse event associated with the embovac aspiration catheter and the embotrap revascularization device.This is listed in the instructions for use (ifu) as such.Per the information provided, ¿bleeding¿ was noted after the procedure where both the embovac and the embotrap devices were used.Therefore, the relationship between the event of ¿bleeding¿ cannot be excluded from both devices.Therefore, this event does meet us fda reporting criteria under 21 cfr 803 under the 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.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: EMBOVAC ASPIRATION CATHETER
• 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: 17450555
• MDR Text Key: 320304346
• Report Number: 3008114965-2023-00554
• Device Sequence Number: 1
• Product Code: NRY
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30767688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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; UNSPECIFIED MICROCATHETER
• Patient Outcome(s): Life Threatening
• Patient Sex: Male