MAUDE Adverse Event Report: CERENOVUS, INC. IC 71, 132 CM, CE; CATHETER, ASPIRATION CATHETER

Catalog Number NIC71132C

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d4.Lot: the lot number was not reported.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Difficulty tracking a catheter (body/shaft) 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.Therefore, the potential for patient injury/death occurring as a result of any tracking difficulty is remote.However, the event occurred along with withdrawal difficulty (distal tip) from the vessel, which could require the use of significant force and can result in device separation, dissection, perforation, or other vessel damage.In this case, the event resulted in a cerebral hemorrhage.A cerebral hemorrhage is a known potential complication associated with the use of the cereglide intermediate catheter and is mentioned in the instructions for use (ifu) as such.Per the ifu, excessive aspiration with the distal tip of the intermediate catheter covered by the vessel wall may cause vessel injury.Carefully investigate location of the distal tip under fluoroscopy prior to aspiration.Based on the physician¿s comment on the small diameter of the patient¿s vessel, this may have been the cause of the cerebral hemorrhage.Despite the physician attributing the event to the small diameter size of the vessel, the occlusion sites were the m1 and m2 segments of the middle cerebral artery (mca), which are considered large vessels that are within the indications of use for the cereglide intermediate catheter.Therefore, the events of ¿brite tip/distal tip - withdrawal difficulty - from vessel¿ and the resulting event of a ¿cerebral hemorrhage¿ does meet us fda reporting criteria 21 cfr 803 with a classification of ¿serious injury.¿ 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.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 3011370111-2023-00208.

Event Description

It was reported, via a personal interaction, that an embotrap iii 5 mm x 37 mm (et309537/lot # unknown) and an ic 71, 132 cm, ce cereglide intermediate catheter (nic71132c/lot # unknown) was used for a mechanical thrombectomy procedure to treat an occlusion of the middle cerebral artery (mca) by combined technique.During the procedure, ¿after confirming distal m1 occlusion, the first pass was performed with a combination of embotrap and cereglide, and recanalization of m1 occlusion was achieved.Then, m2 occlusion was confirmed, so the second pass was made.During the second pass, after the embotrap deployed at m2, the cereglide was advanced and got stuck at the proximal side of m2, so aspiration was conducted at that point.Partial recanalization was confirmed.It was confirmed that no blood was aspirated via cereglide, and there was a strong resistance during the withdrawal of the embotrap and the cereglide.The balloon was deflated to prompt a blood return.Then, hemorrhage was confirmed, which probably occurred due to the m1 straightened during the withdrawal.The procedure was terminated.¿ the events of cereglide- difficulty tracking and withdrawal difficulty, and embotrap iii -withdrawal difficulty into guide/intermediate catheter, was assessed by the treating physician, further commenting, ¿the vessel diameter was small, so the vessel may have shrunk and the embotrap may have been immobilized during the withdrawal, and the withdrawal difficulty occurred due to procedural factor, and nothing wrong with the devices.¿ regarding post-procedure changes in the patient, it was said ¿no additional treatment was taken to the patient, and the patient was under monitoring.¿ a continuous flush was done.Other concomitant devices were a trak microcatheter (stryker) and an optimo 9fr guiding catheter (tokai).The event was reported as such: ¿the procedure was a mechanical thrombectomy of middle cerebral artery cerebral infarction by combined technique using embotrap and cereglide.After confirming distal m1 occlusion, the first pass was performed with a combination of embotrap and cereglide, and recanalization of m1 occlusion was achieved.Then, m2 occlusion was confirmed, so the second pass was made.During the second pass, after the embotrap deployed at m2, the cereglide was advanced and got stuck at the proximal side of m2, so aspiration was conducted at that point.Partial recanalization was confirmed.It was confirmed that no blood was aspirated via cereglide, and there was a strong resistance during the withdrawal of the embotrap and the cereglide.The balloon was deflated to prompt a blood return.Then, hemorrhage was confirmed, which probably occurred due to the m1 straightened during the withdrawal.The procedure was terminated.The physician commented that the vessel diameter was small, so the vessel may have shrunk and the embotrap may have been immobilized during the withdrawal, and the withdrawal difficulty occurred due to procedural factor, and nothing wrong with the devices.No additional treatment was taken to the patient, and the patient was under monitoring.Continuous flush was done.Other concomitant devices were trak microcatheter, optimo 9fr guiding catheter.No further information was made available at the time of this review.

Manufacturer Narrative

Product complaint # (b)(4).Section e1.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).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.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
• Type of Device: CATHETER, ASPIRATION CATHETER
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• 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: 18313104
• MDR Text Key: 330328979
• Report Number: 3007628272-2023-00005
• Device Sequence Number: 1
• Product Code: DQY
• 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,Followup
• Report Date: 01/24/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NIC71132C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/19/2023; 01/12/2024
• Supplement Dates FDA Received: 01/08/2024; 01/24/2024
• 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.; OPTIMO 9F BALLOON CATHETER.; TRAK MICROCATHETER.
• Patient Outcome(s): Life Threatening