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

Catalog Number IC71132CA

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 10/04/2023

Event Type  Injury  

Event Description

As reported via the excellent study (b)(6) , a 90-year-old female (subject (b)(6)) with a medical history of atrial fibrillation and hypertension, presented with an unwitnessed wake up stroke.Last time seen well was on (b)(6) 2023 at 12:30.Symptoms were first observed on (b)(6) 2023 at 13:50.The patient was presented to the treating hospital on (b)(6)2023 at 15:01, where mri imaging confirmed an ischemic stroke.Intravenous tissue plasminogen activator (tpa) was not administered.The suspected origin of the embolism was ¿cardioembolic¿.The patient¿s baseline nihss score was 29 and the modified rankin scale (mrs) score was ¿4-moderately severe disability.Unable to walk without assistance and unable to attend to own bodily needs without assistance¿.On (b)(6) 2023, the patient underwent an endovascular mechanical thrombectomy using an embotrap iii 5 mm x 37 mm (et309537/ 23d047av), an ic 71, 132 cm, ce, asp.Ind./embovac large bore catheter (ic71132ca/ 31054023), and an unknown emboguard balloon (product code/lot # unknown) for occlusions at the m1 and m2 segments of the right middle cerebral artery (mca).The pre-pass mtici score was 0.The 1st pass was done using direct contact aspiration device alone, and resulted in an mtici score of 2a, with clot retrieval in the aspirate.The 2nd pass was done using the embotrap iii device, and resulted in an mtici score of 2a, with clot retrieval in the stent retriever.The 3rd pass was done using direct contact aspiration device alone due to ¿the target vessels being different¿, and resulted in an mtici score of 2a, with no clot retrieval.The 4th pass was made using the same embotrap iii device, ¿due to failure to obtain reopening¿, which resulted in an mtici score of 2b with no clot retrieval.During the procedure, a guidewire was used, but the brand was not specified.In addition, a 0.021 trevo microcatheter and a 0.070 sofia plus intermediate catheter were also used.There were no reported intraoperative study device deficiencies.The patient¿s 24-hour post-procedure nihss score was 27.On (b)(6) 2023, the patient experienced the event of ¿subarachnoid hemorrhage¿, which became known to the site on the same day.The event was assessed by the principal investigator (pi) as not serious, mild in severity, and possibly related to the embotrap iii study device, unrelated to the large bore catheter, and possibly related to the primary surgical procedure.The event was treated with medication, and the outcome of the event is recorded as ¿not recovered/not resolved¿.The patient¿s 7-day post-procedural nihss and mrs assessments were not performed.The patient¿s discharge information was not made available in the clinical database, the crf.On (b)(6) 2023, the patient was discontinued from the clinical study due to ¿death¿ caused by ¿suffocation¿.This death was not reported as an adverse event, but was noted in the clinical database, the crf, under the ¿subject completion/discontinuation¿ form tab.

Manufacturer Narrative

Product complaint # (b)(4).Section a1.Patient identifier: (b)(6).Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31054023 number, and no non-conformances related to the malfunction were identified.The event of ¿death¿ was discussed with the medical safety officer (mso) on 13-oct-2023.Per the mso, given the death occurred a week after the procedure, the outcome of death was likely secondary to the evolution of the patient¿s initial stroke, given the patient¿s poor baseline mrs score of 4 and the patient¿s medical history of atrial fibrillation and hypertension.The outcome of death was not related to the devices used nor to the surgical procedure.Subarachnoid hemorrhage and the outcome of ¿death¿ are both known potential complications associated with the embotrap iii device, the embovac large bore catheter, and the emboguard balloon guide catheter and are mentioned as such in the instructions for use (ifu) for all three devices.There were no alleged quality issues related to the cerenovus device used, as the device performed as intended.The principal investigator (pi) assessed the event of ¿subarachnoid hemorrhage¿ as possibly related to the embotrap iii study device and possibly related to the primary surgical procedure.However, the event occurred the same day, shortly after the surgical procedure, and the correlation between the event and used devices cannot be ruled out completely.Based on this information, the event of ¿subarachnoid hemorrhage¿ does meet us fda reporting criteria under 21 cfr 803 with a classification of a ¿serious injury¿.Regarding the outcome of death (which was not reported as an adverse event), given the death occurred a week after the procedure, this event was likely secondary to the evolution of the patient¿s stroke, given the patient¿s poor baseline mrs score of 4 and the patient¿s medical history of atrial fibrillation and hypertension.Additionally, the cause of death is clearly recorded as ¿suffocation¿, which would not be a complication associated with the use of the cerenovus devices.Based on this information and the assessment of the mso, the outcome of death was not related to the used devices nor to the surgical procedure.Therefore, the event of ¿death¿ does not meet us fda reporting criteria under 21 cfr 803.The file will be re-reviewed if additional information is received at a later date.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 three products involved with the complaint and the associated manufacturer report numbers are 3011370111-2023-00168 and 3011370111-2023-00169.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional/modified information was received on 08-apr-2024.Summary: regarding the adverse event of ¿subarachnoid hemorrhage,¿ the severity of "mild" was updated to "moderate." 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: CATHETER, PERCUTANEOUS
• 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: 18030698
• MDR Text Key: 326917143
• Report Number: 3008114965-2023-00783
• Device Sequence Number: 1
• Product Code: DQY
• 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,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Device Lot Number: 31054023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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: 0.021 TREVO MICROCATHETER; 0.070 SOFIA PLUS INTERMEDIATE CATHETER.; EMBOTRAP III 5 MM X 37 MM.; UNKNOWN EMBOGUARD BALLOON.; UNSPECIFIED GUIDEWIRE.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian