MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 6MM X 11.9CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the event was reported via the sterling study, a 35-year-old female patient with a history of hypertension (not controlled) and migraines, underwent coil embolization of a ruptured left internal carotid artery (ica) aneurysm with hunt & hess grade 2, modified rankin scale (mrs) score 0 on (b)(6) 2022.The dimension of the aneurysm was as follows: height 7mm, dome 5.7mm, maximum aneurysm diameter 7mm, neck size 1.0mm, and dome-to-neck ratio of 5.7mm.The parent vessel diameter was 4.5mm.Per the case report form (crf) and clinical database, the coil embolization was performed with the following three (3) cerenovus coils: a 6mm x 11.9cm micrusframe 10 (mfr100611 / 30686618), a 5mm x 10cm galaxy g3 (gly120510 / 30670811) and a 4mm x 6cm galaxy g3 xsft (glx120406 / 30370441).The coils were delivered and implanted via a concomitant excelsior® sl-10® microcatheter (stryker).In the opinion of the principal investigator, the treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site.Immediate post-procedure modified raymond-roy classification score was class i: complete obliteration.There were no reported study device deficiencies or intraoperative complications.The patient subsequently underwent aneurysm retreatment on (b)(6) 2022 due to a residual neck using a surpass flow diverter.Modified raymond-roy classification score following retreatment was class i: complete obliteration.There were no reported intraoperative complications or aneurysm rupture.The patient was discharged to home on 14-nov-2022 with an mrs = 0.An unscheduled visit was made on (b)(6) 2022 but no details are currently available.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (30686618) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, the investigation will be closed.Aneurysm recanalization is a condition requiring additional intervention or retreatment or can be reasonably expected to result in medical or surgical intervention, including hospitalization.Furthermore, the relationship of the study device to the reported aneurysm recanalization cannot be excluded.Thus, the event is considered serious and mdr reportable.This file will be reassessed if new information becomes available.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 is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00866, 3008114965-2022-00867, and 3008114965-2022-00868.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 sterling study, a 35-year-old female patient with a history of hypertension (not controlled) and migraines, underwent coil embolization of a ruptured left internal carotid artery (ica) aneurysm with hunt & hess grade 2, modified rankin scale (mrs) score 0 on (b)(6) 2022.The dimension of the aneurysm was as follows: height 7mm, dome 5.7mm, maximum aneurysm diameter 7mm, neck size 1.0mm, and dome-to-neck ratio of 5.7mm.The parent vessel diameter was 4.5mm.Per the case report form (crf) and clinical database, the coil embolization was performed with the following three (3) cerenovus coils: a 6mm x 11.9cm micrusframe 10 (mfr100611 / 30686618), a 5mm x 10cm galaxy g3 (gly120510 / 30670811) and a 4mm x 6cm galaxy g3 xsft (glx120406 / 30370441).The coils were delivered and implanted via a concomitant excelsior® sl-10® microcatheter (stryker).In the opinion of the principal investigator, the treatment of the target aneurysm was considered complete, and the study coils were successfully implanted at the target site.Immediate post-procedure modified raymond-roy classification score was class i: complete obliteration.There were no reported study device deficiencies or intraoperative complications.The patient subsequently underwent aneurysm retreatment on (b)(6) 2022 due to a residual neck using a surpass flow diverter.Modified raymond-roy classification score following retreatment was class i: complete obliteration.There were no reported intraoperative complications or aneurysm rupture.The patient was discharged to home on (b)(6) 2022 with an mrs = 0.An unscheduled visit was made on (b)(6) 2022 but no details are currently available.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 09-jan-2023.[additional information]: on 09-jan-2023, additional information was received.The information confirmed that the third cerenovus coil was incorrectly documented as 4mm x 8cm galaxy g3 xtrasoft through a data entry error.The correct coil size is 4mm x 6cm galaxy g3 xtrasoft.The coils did remain within the aneurysm sac.There was no evidence of coil compaction.The reason for the retreatment was the patient received a standard of care magnetic resonance angiography (mra) on post-operative day 2 (pod #2), after the original procedure that showed evidence of filling of the neck and the body of the aneurysm.Although the post-procedural angiographic run for index treatment showed completion occlusion of the aneurysm, based on the mra findings, the principal investigator (pi) decided to perform another digital subtraction angiography (dsa) on (b)(6) 2022 to examine.This showed residual filling of the neck in addition to some filling in the coil interstices.Based on this profile, he decided to re-treat with a surpass device.The information indicated the following, ¿we have defined the reasons for retreatment as, "residual neck" and "other, recurrence of aneurysm.¿ regarding the % of aneurysm occlusion when the recanalization was diagnosed, the response received was, ¿we rated the aneurysm as raymond-roy class iiia with a central core open to flow upon diagnosis on the dsa on (b)(6) 2022.¿ the patient was not symptomatic as a result of the recanalization.Modified information was also received on 09-jan2-2023.The retreatment of target aneurysm was updated in the case report form (crf) from ¿no¿ to ¿yes.¿ reason for "retreatment of target aneurysm" has also been updated in the case report form (crf) to "recurrence of aneurysm".This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00866, 3008114965-2022-00867, and 3008114965-2022-00868.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.

• Brand Name: MICRUSFRAME10 6MM X 11.9CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16078062
• Report Number: 3008114965-2022-00866
• Device Sequence Number: 12302035
• Product Code: KRD
• UDI-Device Identifier: 10886704077855
• UDI-Public: 10886704077855
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 01/10/2023

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: MFR100611
• Device Catalogue Number: MFR100611
• Device Lot Number: 30686618
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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); GALAXY G3 5MM X 10CM; GALAXY G3 XSFT 4MM X 6CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American