MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 7MM X 21CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLY120721

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

Patient Problem Thromboembolism (2654)

Event Date 01/11/2019

Event Type  Injury  

Event Description

The event was reported via the (b)(6) study, a (b)(6) male patient with a history of smoking (previous) and mandibular cancer underwent balloon-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm on (b)(6) 2019 and experienced a thromboembolic event during the procedure.Integrilin/aspirin was administered, and neuroform atlas stent (stryker) was implanted.The patient was asymptomatic; the thromboembolic event was only observed angiographically.The patient was discharged home with self-care on (b)(6) 2019 with modified rankin scale (mrs) score of 0.Platelet reactivity testing was not performed.The dimensions of the bifurcation aneurysm were as follows: aneurysm height 7.5mm, dome 7.2mm, maximum aneurysm diameter 7.5mm, neck size 5.9mm, and dome-to-neck ratio of 1.2mm.The parent vessel diameter was 1.9mm.Balloon-assisted coil embolization was performed with six cerenovus coils: a 7mm x 13.9cm micrusframe 10 (mfr100713 / l13000), a 7mm x 21cm galaxy g3 (gly120721 / l13249), a 5mm x 10cm galaxy g3 (gly120510 / l12927), a 3.00mm x 8.00cm galaxy g3 mini (glm930080 / l13613), a 2.00mm x 4.00cm galaxy g3 mini (glm920040 / l11233), and a 2.00mm x 3.00cm galaxy g3 mini (glm920030 / l13822) via an sl-10 microcatheter (stryker).There was no microcatheter kickback (loss of access to aneurysm) experienced 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 coils were successfully implanted at the target site with 18% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class iiia: residual aneurysm with contrast within coil interstices.The reason additional coils were not placed was ¿adequate occlusion/stasis¿.There were no reported study device deficiencies.The complaint coils remain implanted and are thus not available for evaluation.

Manufacturer Narrative

(b)(4).Information regarding patient date of birth was 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 the sterling study, a (b)(6) male patient with a history of smoking (previous) and mandibular cancer underwent balloon-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm on (b)(6)2019 and experienced a thromboembolic event during the procedure.Integrilin/aspirin was administered, and neuroform atlas stent (stryker) was implanted.The patient was asymptomatic; the thromboembolic event was only observed angiographically.The patient was discharged home with self-care on (b)(6) 2019 with modified rankin scale (mrs) score of 0.Platelet reactivity testing was not performed.The dimensions of the bifurcation aneurysm were as follows: aneurysm height 7.5mm, dome 7.2mm, maximum aneurysm diameter 7.5mm, neck size 5.9mm, and dome-to-neck ratio of 1.2mm.The parent vessel diameter was 1.9mm.Balloon-assisted coil embolization was performed with six cerenovus coils: a 7mm x 13.9cm micrusframe 10 (mfr100713 / l13000), a 7mm x 21cm galaxy g3 (gly120721 / l13249), a 5mm x 10cm galaxy g3 (gly120510 / l12927), a 3.00mm x 8.00cm galaxy g3 mini (glm930080 / l13613), a 2.00mm x 4.00cm galaxy g3 mini (glm920040 / l11233), and a 2.00mm x 3.00cm galaxy g3 mini (glm920030 / l13822) via an sl-10 microcatheter (stryker).There was no microcatheter kickback (loss of access to aneurysm) experienced 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 coils were successfully implanted at the target site with 18% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class iiia: residual aneurysm with contrast within coil interstices.The reason additional coils were not placed was ¿adequate occlusion/stasis¿.There were no reported study device deficiencies.The complaint coils remain implanted and are 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 (l13249) 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 and surgical intervention to preclude permanent impairment or damage, and the relationship of the study coils 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.This is one of 6 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00708, 3008114965-2021-00710, 3008114965-2021-00711, 3008114965-2021-00712, and 3008114965-2021-00713.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 13-jan-2022.The event was reported via the sterling study, a 60-year-old male patient with a history of smoking (previous) and mandibular cancer underwent balloon-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm on (b)(6) 2019 and experienced a thromboembolic event during the procedure.Integrilin/aspirin was administered, and neuroform atlas stent (stryker) was implanted.The patient was asymptomatic; the thromboembolic event was only observed angiographically.The patient was discharged home with self-care on (b)(6) 2019 with modified rankin scale (mrs) score of 0.Platelet reactivity testing was not performed.The dimensions of the bifurcation aneurysm were as follows: aneurysm height 7.5mm, dome 7.2mm, maximum aneurysm diameter 7.5mm, neck size 5.9mm, and dome-to-neck ratio of 1.2mm.The parent vessel diameter was 1.9mm.Balloon-assisted coil embolization was performed with six cerenovus coils: a 7mm x 13.9cm micrusframe 10 (mfr100713 / l13000), a 7mm x 21cm galaxy g3 (gly120721 / l13249), a 5mm x 10cm galaxy g3 (gly120510 / l12927), a 3.00mm x 8.00cm galaxy g3 mini (glm930080 / l13613), a 2.00mm x 4.00cm galaxy g3 mini (glm920040 / l11233), and a 2.00mm x 3.00cm galaxy g3 mini (glm920030 / l13822) via an sl-10 microcatheter (stryker).There was no microcatheter kickback (loss of access to aneurysm) experienced 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 coils were successfully implanted at the target site with 18% angiosuite packing density.Immediate post-procedure modified raymond-roy classification score was class iiia: residual aneurysm with contrast within coil interstices.The reason additional coils were not placed was ¿adequate occlusion/stasis¿.There were no reported study device deficiencies.The complaint coils remain implanted and are thus not available for evaluation.[additional information]: on 13-jan-2022, additional information was received.The information indicated that the physician attributed the cause of the event to the broad-necked aneurysm.The thrombus was identified during the coiling of the aneurysm.The thrombus was not flow-limiting and did not 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 thrombosis did not result in an infarction.Integrilin and aspirin were administered as treatment.The event did not require prolonged hospitalization.The relationship of the study coil to the reported event is possible.This is one of 6 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00708, 3008114965-2021-00710, 3008114965-2021-00711, 3008114965-2021-00712, and 3008114965-2021-00713.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include modified information received on 07-oct-2022.[modified information]: the previously reported thromboembolic event has been entered in the case report form (crf) as ¿intraoperative nonocclusive thrombus formation¿ and later on updated to ¿intraoperative anterior communicating artery nonocclusive thrombus formation¿.The value entered for the start date of the event is (b)(6)2019.And the awareness date has been updated from ¿(b)(6)2022¿ to ¿(b)(6)2019¿.It is also noted in the crf that the outcome for this ae has a data value of ¿recovered/resolved¿ with an end date of (b)(6) 2019.This is one of 6 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00708, 3008114965-2021-00709, 3008114965-2021-00710, 3008114965-2021-00711, 3008114965-2021-00712, and 3008114965-2021-00713.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 7MM X 21CM
• Type of Device: 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 ; 949789-868
• MDR Report Key: 13101695
• MDR Text Key: 285761344
• Report Number: 3008114965-2021-00709
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077565
• UDI-Public: 10886704077565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: GLY120721
• Device Catalogue Number: GLY120721
• Device Lot Number: L13249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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: GALAXY G3 5MM X 10CM; GALAXY G3 MINI 2MM X 3CM; GALAXY G3 MINI 2MM X 4CM; GALAXY G3 MINI 3MM X 8CM; MICRUSFRAME10 7MM X 13.9CM; NEUROFORM ATLAS® STENT SYSTEM (STRYKER); SL-10® MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White