MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 4MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120408
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the event was reported via (b)(6), a (b)(6) year-old male patient with a history of hypertension, coronary artery disease (cad), and active smoking underwent coil embolization of an unruptured anterior cerebral artery (aca) on (b)(6) 2021 and experienced a thromboembolic event during the procedure.Medication was administered as treatment.The patient was asymptomatic; the thromboembolic event was only observed angiographically.The patient was discharged home with self-care on (b)(6) 2021 with modified rankin scale (mrs) score of 0.Platelet reactivity testing was not performed.The dimensions of the aca bifurcation aneurysm were as follows: aneurysm height 3.7mm, dome 5mm, maximum aneurysm diameter 5.3mm, neck size 2.9mm, and dome-to-neck ratio of 1.7mm.The parent vessel diameter was 2.4mm.Coil embolization was performed with the implantation of two competitor (stryker) coils and a 4mm x 8cm galaxy g3 xsft (glx120408 / l13313) coil via an excelsior sl-10 microcatheter (stryker).There was microcatheter kickback (loss of access to aneurysm) experienced twice during the procedure.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coil was successfully implanted at the target site with 30% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class ii: residual neck = persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac.There were no reported study device deficiencies.180-day follow-up visit was performed in the clinic on (b)(6) 2021; his mrs score was 0.The complaint coil remains implanted and is thus not available for evaluation.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (l13313) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Cerebral thrombosis is a known potential adverse event associated with coil embolization procedures.With the information provided, it is not possible to determine the root cause of the thromboembolic event.However, there are patient, procedural, and pharmacological factors that may have contributed to the reported event.Based on the available information, there is no indication of any device performance or manufacturing issues related to the reported event.Since the intraoperative thromboembolic event required medical intervention to preclude permanent impairment or damage, and the relationship of the study coil to the reported event cannot be excluded.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.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 (b)(6), a (b)(6) year-old male patient with a history of hypertension, coronary artery disease (cad), and active smoking underwent coil embolization of an unruptured anterior cerebral artery (aca) on (b)(6) 2021 and experienced a thromboembolic event during the procedure.Medication was administered as treatment.The patient was asymptomatic; the thromboembolic event was only observed angiographically.The patient was discharged home with self-care on (b)(6) 2021 with modified rankin scale (mrs) score of 0.Platelet reactivity testing was not performed.The dimensions of the aca bifurcation aneurysm were as follows: aneurysm height 3.7mm, dome 5mm, maximum aneurysm diameter 5.3mm, neck size 2.9mm, and dome-to-neck ratio of 1.7mm.The parent vessel diameter was 2.4mm.Coil embolization was performed with the implantation of two competitor (stryker) coils and a 4mm x 8cm galaxy g3 xsft (glx120408 / l13313) coil via an excelsior sl-10 microcatheter (stryker).There was microcatheter kickback (loss of access to aneurysm) experienced twice during the procedure.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coil was successfully implanted at the target site with 30% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class ii: residual neck = persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac.There were no reported study device deficiencies.180-day follow-up visit was performed in the clinic on (b)(6) 2021; his mrs score was 0.The complaint coil remains implanted and is thus not available for evaluation.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 11-jan-2022.[additional information]: the event was reported via the sterling study, a 51-year-old male patient with a history of hypertension, coronary artery disease (cad), and active smoking underwent coil embolization of an unruptured anterior cerebral artery (aca) on (b)(6) 2021 and experienced a thromboembolic event during the procedure.Medication was administered as treatment.The patient was asymptomatic; the thromboembolic event was only observed angiographically.The patient was discharged home with self-care on (b)(6) 2021 with modified rankin scale (mrs) score of 0.Platelet reactivity testing was not performed.The dimensions of the aca bifurcation aneurysm were as follows: aneurysm height 3.7mm, dome 5mm, maximum aneurysm diameter 5.3mm, neck size 2.9mm, and dome-to-neck ratio of 1.7mm.The parent vessel diameter was 2.4mm.Coil embolization was performed with the implantation of two competitor (stryker) coils and a 4mm x 8cm galaxy g3 xsft (glx120408 / l13313) coil via an excelsior sl-10 microcatheter (stryker).There was microcatheter kickback (loss of access to aneurysm) experienced twice during the procedure.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete, and the study coil was successfully implanted at the target site with 30% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class ii: residual neck = persistence of any portion of the original defect of the arterial wall but without opacification of the aneurysmal sac.There were no reported study device deficiencies.180-day follow-up visit was performed in the clinic on (b)(6) 2021; his mrs score was 0.The complaint coil remains implanted and is thus not available for evaluation.On 11-jan-2022, additional information was received.Per the information, the physician attributed the cause of the event to a complex anatomy-fenestrated aca a1 segment.The relationship of the study coil to the reported event was deemed possible.When the thrombus was identified, immediate anti-thrombotic medication was administered until the clot was resolved.Intra-arterial integrilin bolus (2mg/ml with 6.8ml) and perfusor 0.75mg/ml 12ml/h for 6 hours were administered per standard protocol.The thrombus was not flow-limiting nor did it embolize.There was no coil protrusion into the parent vessel that may have contributed to the event.There was no evidence of parent artery nor side branch vessel occlusion.The thrombus did not result in an infarction.The event did not require prolonged hospitalization.The last two coils were associated with the microcatheter kickback; per the case report form (crf), a 2mm x 4cm target nano coil (stryker) (competitor) and the complaint coil were the last two coils placed.Based on the additional information received on 11-jan-2022, positioning problem was added in the medical device problem code to capture the reported microcatheter kickback associated with the cerenovus coil.The file will be re-reviewed if additional information is received at a later date.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: GALAXY G3 XSFT 4MM X 8CM
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13153731
• Report Number: 3008114965-2021-00701
• Device Sequence Number: 14472853
• Product Code: KRD
• UDI-Device Identifier: 10886704077732
• UDI-Public: 10886704077732
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 07/31/2021
• Device Model Number: GLX120408
• Device Catalogue Number: GLX120408
• Device Lot Number: L13313
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 4MM X 2CM TARGET NANO COIL (STRYKER); 6MM X 3CM TARGET COIL (STRYKER); EXCELSIOR® SL-10® MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 77 KG