MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY 6F, MPD 90CM; PERCUTANEOUS CATHETER

Model Number	670-258-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth and weight were not provided.[conclusion]: the event was reported via the membrane study.The 80-year-old female subject with a medical history of coronary artery disease (cad), diabetes, hypertension, liver disease and previously smoking, underwent middle meningeal artery (mma) embolization of a left frontal subdural hematoma (sdh) on (b)(6) 2022.The patient was randomized into the non-surgical medical management (nsmm) and mma embolization cohort of the study.The patient¿s baseline markwalder grading scale (mgs) score was 2 and modified rankin scale (mrs) score was 2.The sdh thickness was 23.The mma embolization procedure was performed on (b)(6) 2022 via right radial access.Trufill n-bca 1x1 gram glue (631500 / lot # jn8395); (4:1 oil: n-bca ratio) was delivered beyond the midline via an excelsior® sl-10® microcatheter (stryker).A 6f, 90cm mpd envoy® guiding catheter (67025890 / 30688478) was used during the procedure.The anterior branch of the mma was embolized.During the procedure the patient experienced vasospasm of the external carotid artery (eca) for approximately 14 minutes.This event was treated medically.In the opinion of the treating physician the embolization was successful.The patient was discharged on (b)(6) 2022 with mini mental state exam (mmse) score of 20, a markwalder grading scale (mgs) score of 1 and modified rankin scale (mrs) score of 1.The patient¿s 1 month follow-up visit was performed on (b)(6) 2022 (via phone/telehealth).A computed tomography (ct) scan was performed on (b)(6) 2022, which revealed a maximum hematoma thickness 18, the markwalder grading scale (mgs) score was 1 and his modified rankin scale (mrs) score was 1.The patient¿s 3-month follow-up visit was performed on (b)(6) 2022.A ct scan was performed on 16-aug-2022, which revealed a maximum hematoma thickness 11, the markwalder grading scale (mgs) score was 0 and his modified rankin scale (mrs) score was 1.On (b)(6) 2022 the patient experienced left leg weakness and convulsion.The principal investigator (pi) assessed this event as moderate in severity, serious (in-patient or prolonged hospitalization), not related to the study device, to the mma embolization procedure, the medication used to treat the subdural hematoma (sdh), or the surgical procedure used to treat the sdh.The patient was hospitalized from (b)(6) 2022 to (b)(6) 2022.The patient recovered and the event was resolved on (b)(6) 2022.A head ct, ct angio head/neck, mri brain, and eeg were performed.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30688478) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.Vasospasm is a known complication associated with the use of the envoy distal access (da) guiding catheter and is mentioned in the instructions for use (ifu) as such.The device performed as intended and there was no evidence to suggest a device malfunction or quality issue.However, the relationship between envoy and the reported event cannot be excluded since the event occurred during the surgical procedure.Therefore, this event is considered serious and mdr reportable.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The event was reported via the membrane study.The 80-year-old female subject with a medical history of coronary artery disease (cad), diabetes, hypertension, liver disease and previously smoking, underwent middle meningeal artery (mma) embolization of a left frontal subdural hematoma (sdh) on (b)(6) 2022.The patient was randomized into the non-surgical medical management (nsmm) and mma embolization cohort of the study.The patient¿s baseline markwalder grading scale (mgs) score was 2 and modified rankin scale (mrs) score was 2.The sdh thickness was 23.The mma embolization procedure was performed on (b)(6) 2022 via right radial access.Trufill n-bca 1x1 gram glue (631500 / lot # jn8395); (4:1 oil: n-bca ratio) was delivered beyond the midline via an excelsior® sl-10® microcatheter (stryker).A 6f, 90cm mpd envoy® guiding catheter (67025890 / 67025890) was used during the procedure.The anterior branch of the mma was embolized.During the procedure the patient experienced vasospasm of the external carotid artery (eca) for approximately 14 minutes.This event was treated medically.In the opinion of the treating physician the embolization was successful.The patient was discharged on (b)(6) 2022 with mini mental state exam (mmse) score of 20, a markwalder grading scale (mgs) score of 1 and modified rankin scale (mrs) score of 1.The patient¿s 1 month follow-up visit was performed on (b)(6) 2022 (via phone/telehealth).A computed tomography (ct) scan was performed on (b)(6) 2022, which revealed a maximum hematoma thickness 18, the markwalder grading scale (mgs) score was 1 and his modified rankin scale (mrs) score was 1.The patient¿s 3-month follow-up visit was performed on (b)(6) 2022.A ct scan was performed on 16-aug-2022, which revealed a maximum hematoma thickness 11, the markwalder grading scale (mgs) score was 0 and his modified rankin scale (mrs) score was 1.On (b)(6) 2022 the patient experienced left leg weakness and convulsion.The principal investigator (pi) assessed this event as moderate in severity, serious (in-patient or prolonged hospitalization), not related to the study device, to the mma embolization procedure, the medication used to treat the subdural hematoma (sdh), or the surgical procedure used to treat the sdh.The patient was hospitalized from (b)(6) 2022 to (b)(6) 2022.The patient recovered and the event was resolved on (b)(6) 2022.A head ct, ct angio head/neck, mri brain, and eeg were performed.

• Brand Name: ENVOY 6F, MPD 90CM
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 15746903
• Report Number: 3008114965-2022-00723
• Device Sequence Number: 7075044
• Product Code: DQY
• UDI-Device Identifier: 10886704031758
• UDI-Public: 10886704031758
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 670-258-90
• Device Catalogue Number: 67025890
• Device Lot Number: 30688478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR® SL-10® MICROCATHETER (STRYKER); TRUFILL N-BCA-1 GRAM KIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White