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

Catalog Number IC71132CA

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

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Embolism/Embolus (4438)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The lot number was not reported; udi unavailable.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 3011370111-2023-00015 and 3008114965-2023-00077.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported from a personal interaction that a patient underwent a thrombectomy, combined technique, procedure for an occlusion at the m1-m2 segment of the middle cerebral artery (mca) with a 5mm x 37mm embotrap iii (et309537/unknown lot) revascularization device and an embovac ic 71, 132 cm, ce, asp.Ind.(ic71132ca/unknown lot) aspiration catheter.Per details of the procedure, a phenom 27 (medtronic) microcatheter and a synchro (stryker) micro-guidewire with a knuckle-shaped tip were used.It was stated that the physician changed to another microcatheter, a trevo trak 21 (stryker, because the phenom27 got caught on the siphon and was unable to advance.It was stated that probably an embolization to new territory (ent) occurred at the time the microcatheter has crossed the occlusion region but went unnoticed.The complaint embotrap iii has been placed to the site where the obstruction was originally identified, and a first pass was performed.There was no resistance felt.Although a thrombus was removed, upon new angiography an ent and bleeding from three regions at the m2 segment of the mca were confirmed.N-butyl cyanoacrylate (nbca) was used to stop bleeding.It was stated how the new location thrombus was treated.It was further stated that the bleeding might be related not only by the complaint devices but also caused by a combination of various factors, such as the fact that it was unknown that the patient had three m2 branches until the thrombus was removed.It was reported that the patient experienced foot and hand paralysis.While the former has resolved, the latter remains.It is not known if a continuous flush was done.

Manufacturer Narrative

Product complaint#: (b)(4).Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported from a personal interaction that a patient underwent a thrombectomy, combined technique, procedure for an occlusion at the m1-m2 segment of the middle cerebral artery (mca) with a 5mm x 37mm embotrap iii (et309537/unknown lot) revascularization device and an embovac ic 71, 132 cm, ce, asp.Ind.(ic71132ca/unknown lot) aspiration catheter.Per details of the procedure, a phenom 27 (medtronic) microcatheter and a synchro (stryker) micro-guidewire with a knuckle-shaped tip were used.It was stated that the physician changed to another microcatheter, a trevo trak 21 (stryker, because the phenom27 got caught on the siphon and was unable to advance.It was stated that probably an embolization to new territory (ent) occurred at the time the microcatheter has crossed the occlusion region but went unnoticed.The complaint embotrap iii has been placed to the site where the obstruction was originally identified, and a first pass was performed.There was no resistance felt.Although a thrombus was removed, upon new angiography an ent and bleeding from three regions at the m2 segment of the mca were confirmed.N-butyl cyanoacrylate (nbca) was used to stop bleeding.It was stated how the new location thrombus was treated.It was further stated that the bleeding might be related not only by the complaint devices but also caused by a combination of various factors, such as the fact that it was unknown that the patient had three m2 branches until the thrombus was removed.It was reported that the patient experienced foot and hand paralysis.While the former has been resolved, the latter remains.It is not known if a continuous flush was done.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Distal embolization and hemorrhage are known potential complications associated with endovascular mechanical thrombectomy for acute ischemic stroke cases and are listed in the embotrap instructions for use (ifu) as such.Clinical and procedural factors, including vessel characteristics, device selection, device interaction, and operator technique, may have contributed rather than the design or manufacture of the device.Because of the loss of normal autoregulation in the vessels supplying the infarcted tissues with the inability to retain blood inside of the arteries, the risk of hemorrhage will occur with return of normal blood flow.Given the physician¿s assessment and the occurrence of the bleeding during devices usage, the relationship of the embotrap iii and the bleeding cannot be ruled out.Although there was no reported device performance issue/ malfunction, this event will be conservatively reported to the fda with the classification of ¿serious injury¿.Additionally, there was the need for additional intervention by usage of nbca to treat the bleeding.The complaint will be reassessed if additional information becomes available.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.

• 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: 16264267
• MDR Text Key: 308379695
• Report Number: 3008114965-2023-00077
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 5 MM X 37 MM.; PHENOM 27 (MEDTRONIC) MICROCATHETER.; SYNCHRO (STRYKER) MICRO-GUIDEWIRE.; TREVO TRAK 21 MICROCATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR