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

Catalog Number IC71132CA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event: the date of the event was not reported.(b)(6).(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during a mechanical thrombectomy procedure, the physician encountered difficulty advancing the 132cm embovac 71 (ic71132ca/c51239) aspiration catheter and excelsior xt-27 (stryker) microcatheter distally after two passes, and the devices appeared to be stuck in the internal carotid artery (ica) over the ophthalmic.The devices then jumped forward in the m1 segment of the middle cerebral artery (mca), ¿probably perforating¿.After diagnostic check, he tried to go distal again with the embovac using the excelsior xt-2 microcatheter but the microcatheter did not advance and became damaged.The procedure was successfully completed with a sofia plus (microvention) catheter that was occlusive and stopped the bleeding.There were reportedly no consequences for the patient at the end of the procedure.Visual inspection of the embovac catheter after the procedure revealed kinking proximal to the tip (light purple segment).The physician highlighted that the neuron max (penumbra) long guide sheath (lgs) was very proximal (extracranial carotid) because he had to place a carotid stent before, so he positioned the lgs below that.He suggested that perhaps the embovac ¿was really stressed¿ because of the lack of neuron max support.The first pass was made with an embotrap revascularization device and the second pass was made with only aspiration.Photos of the embovac catheter were received.Additional information received on 15-apr-2020 indicated that the segment of the mca involved was the origin of the m2 and the vessel was not perforated, but ¿delaminated¿.After the vessel became ¿delaminated¿, the physician replaced the device with a sofia plus catheter in order to inject glue; however, no additional treatment was required because the sofia plus catheter was occlusive and stopped the bleeding.He did not aspirate again with the sofia plus because he had already performed two passes with the embovac.Final mtici score is reportedly unknown.Additional information received on 16-apr-2020 indicated that the catheter kinked immediately outside the tip of the neuron max lgs in the ica.The catheter was kinked at the distal body/shaft (white/light purple segment).There was no difficulty removing the catheter from the patient; however, it was reported that target position was lost.The physician replaced the catheter with a sofia plus that navigated to the target vessel without any issue.The catheter had not been re-shaped after removal from the packaging.No further relevant details were provided.Based on the photos provided, it can determine that the 132cm embovac 71 asp.Catheter has a compressed condition on the body.Also, a curvy condition with residues of dry blood on the distal section was noted.No other damages could be observed.A manufacturing record evaluation was performed for the finished device c51239 number, and no non-conformances related to the reported complaint condition were identified the reported condition ¿catheter (body/shaft) - kinked/bent-in patient¿ was confirmed, some damages could be noted on the distal section of the device, based on the images received.The reported condition ¿catheter (body/shaft) - tracking difficulty¿ could not be evaluated based on the images.Difficulty tracking a catheter through the vasculature is a known procedural occurrence.The consequences of tracking difficulty occurring during clinical use of the device are usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient anatomy, operator technique, and appropriate device selection.Vessel injury or dissection is a known potential procedural complication associated with the embovac aspiration catheter and is listed in the instructions for use (ifu) as such.With the amount of information available and without films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, clinical and procedural factors, including patient anatomy, vessel characteristics, and operator technique/manipulation, may have contributed to the event rather than the design or manufacture of the device.Additional information may be available at a later date if case imaging is returned for evaluation.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

Event Description

A report from the field indicated that during a mechanical thrombectomy procedure, the physician encountered difficulty advancing the 132cm embovac 71 (ic71132ca/c51239) aspiration catheter and excelsior xt-27 (stryker) microcatheter distally after two passes, and the devices appeared to be stuck in the internal carotid artery (ica) over the ophthalmic.The devices then jumped forward in the m1 segment of the middle cerebral artery (mca), ¿probably perforating¿.After diagnostic check, he tried to go distal again with the embovac using the excelsior xt-2 microcatheter but the microcatheter did not advance and became damaged.The procedure was successfully completed with a sofia plus (microvention) catheter that was occlusive and stopped the bleeding.There were reportedly no consequences for the patient at the end of the procedure.Visual inspection of the embovac catheter after the procedure revealed kinking proximal to the tip (light purple segment).The physician highlighted that the neuron max (penumbra) long guide sheath (lgs) was very proximal (extracranial carotid) because he had to place a carotid stent before, so he positioned the lgs below that.He suggested that perhaps the embovac ¿was really stressed¿ because of the lack of neuron max support.The first pass was made with an embotrap revascularization device and the second pass was made with only aspiration.The embovac catheter is not available for analysis; however, photos of the catheter have been returned which confirm the alleged damage.Reportedly, case imaging will also be sent for evaluation.No further information was provided at the time of complaint initiation.Additional information received on 15-apr-2020 indicated that the segment of the mca involved was the origin of the m2 and the vessel was not perforated, but ¿delaminated¿.After the vessel became ¿delaminated¿, the physician replaced the device with a sofia plus catheter in order to inject glue; however, no additional treatment was required because the sofia plus catheter was occlusive and stopped the bleeding.He did not aspirate again with the sofia plus because he had already performed two passes with the embovac.Final mtici score is reportedly unknown.Additional information received on 16-apr-2020 indicated that the catheter kinked immediately outside the tip of the neuron max lgs in the ica.The catheter was kinked at the distal body/shaft (white/light purple segment).There was no difficulty removing the catheter from the patient; however, it was reported that target position was lost.The physician replaced the catheter with a sofia plus that navigated to the target vessel without any issue.The catheter had not been re-shaped after removal from the packaging.No further relevant details were provided.

• Brand Name: 132CM EMBOVAC 71 ASP. CATHETER
• 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 Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9981579
• MDR Text Key: 195648675
• Report Number: 3008114965-2020-00118
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: IC71132CA
• Device Lot Number: C51239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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
• Patient Outcome(s): Life Threatening; Required Intervention