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

Catalog Number IC71132CA

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/17/2022

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of death: not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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 4.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2022-00099.

Event Description

It was reported from a personal interaction that a patient underwent thrombectomy for an obstruction between the internal carotid artery (ica) and the m1 segment of the middle cerebral artery (mca) where embotrap iii revascularization device (et309537/ 21k060av) and 132cm embovac 71 aspiration catheter (ic71132ca/ 30729953) were used per their respective instructions for use (ifus).Per event description, the embotrap iii was deployed, and an attempt was made by the physician to retract it; however, the embotrap iii got stuck and an intense resistance was felt.A balloon guiding catheter (optimo) was then inserted causing dissociation/ dissection of the ica.There was reported difficulty in pulling the embotrap iii and the embovac devices.As a result, a microcatheter was ¿put on and removed together¿ then the procedure was completed.It was reported that the patient was unstable and hospitalized, however no specific adverse event/ patient injury was mentioned.The treating physician commented that the ¿degree of seriousness is serious¿.No stenosis was noted, and it was claimed that the thrombus ¿may have been hard¿.The physician is seeking advise on what to do in such a case as the course of the patient¿s surgery has been recorded.It is unknown if a continuous flush was done or if there were any other concomitant device/s used.Additional information was received on (b)(6) 2022.It was claimed that when the optimo balloon guiding catheter was used during the procedure, it caused ¿damaging the balloon part¿ in addition to the ica dissection.A 4mm trevo stent was also deployed alternately.Resistance was still experienced however it was possible to retract the device.Two passes were done.Recanalization was obtained at the mca.Although there was ica dissociation noted, the blood flow through the anterior communication artery was good based on the angiography images obtained.Procedure was then completed.It was reported that ¿the mca was reopened¿ and the patient expired due to cardiac failure.It is unclear from the additional information provided what is meant by ¿the mca was reopened¿ and when it was done.The optimo balloon guiding catheter used was 8fr.The only demographic information provided for this patient is the gender as male.Additional information was received on (b)(6) 2022 regarding the physician¿s assessment of the patient¿s death.The doctor commented that the patient already had a history of heart failure.It was likely that the patient expired because his heart failure ¿progressed¿.In case the vascular dissection did not occur during the surgery, the physician claims ¿death from heart failure would have been considered¿.

Manufacturer Narrative

Product complaint # (b)(4).Updated section on this medwatch report: b2, b4, b5, e1, e3, g3, g6, h2, h6 and h10.Section b5: additional information received on 25-oct-2022 indicated that event occurred on 17-sep-2022.The brand and lot number of the microcatheter used are unknown.The statement ¿the mca was reopened¿ meant "recanalization at mca was obtained" and not that the patient underwent an additional surgical procedure.Withdrawal of the embotrap was performed as per ifu.There is no patient information available.Complaint conclusion: it was reported from a personal interaction that a patient underwent thrombectomy for an obstruction between the internal carotid artery (ica) and the m1 segment of the middle cerebral artery (mca) where embotrap iii revascularization device (et309537/ 21k060av) and 132cm embovac 71 aspiration catheter (ic71132ca/ 30729953) were used per their respective instructions for use (ifus).Per event description, the embotrap iii was deployed, and an attempt was made by the physician to retract it; however, the embotrap iii got stuck and an intense resistance was felt.A balloon guiding catheter (optimo) was then inserted causing dissociation/ dissection of the ica.There was reported difficulty in pulling the embotrap iii and the embovac devices.As a result, a microcatheter was ¿put on and removed together¿ then the procedure was completed.It was reported that the patient was unstable and hospitalized, however no specific adverse event/ patient injury was mentioned.The treating physician commented that the ¿degree of seriousness is serious¿.No stenosis was noted, and it was claimed that the thrombus ¿may have been hard¿.The physician is seeking advice on what to do in such a case as the course of the patient¿s surgery has been recorded.It is unknown if a continuous flush was done or if there were any other concomitant device/s used.Additional information received on 11-oct-2022 indicated that when the optimo balloon guiding catheter was used during the procedure, it caused ¿damaging the balloon part¿ in addition to the ica dissection.A 4mm trevo stent was also deployed alternately.Resistance was still experienced however it was possible to retract the device.Two passes were done.Recanalization was obtained at the mca.Although there was ica dissociation noted, the blood flow through the anterior communication artery was good based on the angiography images obtained.Procedure was then completed.It was reported that ¿the mca was reopened¿ and the patient expired due to cardiac failure.It is unclear from the additional information provided what is meant by ¿the mca was reopened¿ and when it was done.The optimo balloon guiding catheter used was 8fr.The only demographic information provided for this patient is the gender as male.The lot numbers of the embotrap iii and the embovac devices were also provided and included in the narrative above.Additional information received on 12-oct-2022 regarding the physician¿s assessment of the patient¿s death.The doctor commented that the patient already had a history of heart failure.It was likely that the patient expired because his heart failure ¿progressed¿.In case the vascular dissection did not occur during the surgery, the physician claims ¿death from heart failure would have been considered¿.Additional information received on 25-oct-2022 indicated that event occurred on 17-sep-2022.The brand and lot number of the microcatheter used are unknown.The statement ¿the mca was reopened¿ meant "recanalization at mca was obtained" and not that the patient underwent an additional surgical procedure.Withdrawal of the embotrap was performed as per ifu.There is no patient information available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30729953 number, and no non-conformances related to the malfunction were identified.Vessel dissection and death are included in the possible complications associated with the use of the embotrap iii revascularization device and the embovac aspiration catheter as listed in its respective ifus.The treating physician accounts the death being caused by the patient¿s medical history of heart failure and would have occurred regardless of an internal carotid artery dissection resulting from the procedure.There were device performance issues reported during the use of embotrap iii and embovac.Such device issues can critically prolong the surgery especially when there is loss of access to the occluded treatment site, thereby increasing the patient¿s risk for vessel damage, vasospasm, creation of emboli, ischemia and/or infarct.It may also require additional intervention.Therefore, this meets the mdr reporting criteria.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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): CODMAN AND SHURTLEFF INC.(MIRAMAR); 3260 executive way; miramar FL 33025
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15632134
• MDR Text Key: 302003959
• Report Number: 3008114965-2022-00671
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30729953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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: 4MM TREVO STENT.; EMBOTRAP III 5 MM X 37 MM.; OPTIMO BALLOON GUIDING CATHETER.; UNSPECIFIED MICROCATHETER.
• Patient Outcome(s): Death
• Patient Sex: Male