MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120304
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	08/06/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: ding d, liu kc.Management strategies for intraprocedural coil migration during endovascular treatment of intracranial aneurysms.J neurointerv surg.2014 jul;6(6):428-31.Doi: 10.1136/neurintsurg-2013-010872.Epub 2013 aug 6.Pmid: 23921713.The expiration date of the device is not known as the device lot number is not available / not reported.The initial reporter phone is not available.The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Since the alleged coil migration resulted in cerebral thrombosis with the need for medical and surgical intervention to preclude further damage, the event is considered serious and mdr reportable.There is no indication of a device design or manufacturing issue.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
This complaint is from a literature source.The citation is as follows: ding d, liu kc.Management strategies for intraprocedural coil migration during endovascular treatment of intracranial aneurysms.J neurointerv surg.2014 jul;6(6):428-31.Doi: 10.1136/neurintsurg-2013-010872.Epub 2013 aug 6.Pmid: 23921713.Objective and methods: this article presents a particular management strategy for correction of a distal coil migration in a patient undergoing endovascular coil embolization of an anterior communicating artery aneurysm.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: 3mm x 4cm galaxy g3 xsft coil & prowler 10 microcatheter.Concomitant cerenovus devices that were also used in this study: galaxy g3 xsft coils; galaxy g3 mini coils.Concomitant non-cerenovus devices that were also used in this study: 6f chaperon guiding catheter (microvention); 0.014" transend microwire (boston scientific); 3/30 mm atlas 2 stent (stryker).Adverse event(s) and provided interventions: a (b)(6) male patient underwent endovascular coil embolization of a ruptured anterior communicating artery aneurysm.A prowler 10 microcatheter was carefully advanced over a 0.014 transend microwire (boston scientific) and positioned into the aneurysm sac.One 4/8 mm galaxy g3 xsft coil was then inserted and detached into aneurysm.At the beginning of the introduction of the second coil 3/4, the tip of the microcatheter descended to the aneurysm neck.As soon as it was detached, the flow carried a part of the coil from the aneurysm to a2 segment of the right anterior cerebral artery.The next contrast injection demonstrated thrombosis of the right a2 without flow distal to the migrated coil.The right a2 was then catheterized through the left a1 with an excelsior 10 microcatheter.The microcatheter was advanced proximal to the migrated coil, and 5 ml heparin solution was infused.The microcatheter was passed carefully distal to the coil, and a 3/30 mm atlas 2 stent (stryker) was deployed and successfully fixed and stabilized the migrated coil.Imaging demonstrated good repermeabilization of the right a2 segment.Angiographic occlusion of the aneurysm was obtained after the safe insertion and detachment of other two coils (2/ 8 mm galaxy g3 xsft and 1.5/ 4 mm galaxy g3 mini).A cerebral computed tomography (ct) scan was performed 7 days postoperatively and showed the total subarachnoid hemorrhage (sah) resorption.The patient was discharged home after 17 days of hospitalization in good neurological condition.

• Brand Name: GALAXY G3 XSFT 3MM X 4CM
• 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: 13667932
• Report Number: 3008114965-2022-00168
• Device Sequence Number: 5466492
• Product Code: KRD
• UDI-Device Identifier: 10886704077688
• UDI-Public: 10886704077688
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GLX120304
• Device Catalogue Number: GLX120304
• 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: 03/02/2022
• Initial Report FDA Received Date: 03/04/2022
• 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: 0.014" TRANSEND MICROWIRE (BOSTON SCIENTIFIC); 3/30 MM ATLAS 2 STENT (STRYKER); 6F CHAPERON GUIDING CATHETER (MICROVENTION); GALAXY G3 MINI COILS; GALAXY G3 XSFT COILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male