MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 5MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLY120515

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

Patient Problem Thromboembolism (2654)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was not provided.Device 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 (b)(6) study, a (b)(6) female patient with a history of congestive heart failure (chf), diabetes, controlled hypertension, hypothyroidism, gastroesophageal reflux disease (gerd), sleep apnea, liver cirrhosis, esophageal varices, osteoporosis, idiopathic pulmonary fibrosis (ipf), chronic obstructive pulmonary disease (copd), and class 1 obesity (bmi 30 kg/m2) underwent stent-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm 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 the following day with modified rankin scale (mrs) score of 2, unchanged from baseline.Platelet reactivity testing was not performed.The dimensions of the acom bifurcation aneurysm were as follows: aneurysm height 9.7mm, dome 8.4mm, maximum aneurysm diameter 6.6mm, neck size 3.6mm, and dome-to-neck ratio of 2.3mm.The parent vessel diameter was 3.7mm.Stent-assisted coil embolization was performed with six cerenovus coils: a 10mm x 30cm galaxy g3 (gly121030 / 30386790), a 9mm x 14cm micrusframe 14 (mfr140914 / k10025), a 5mm x 15cm galaxy g3 (gly120515 / 30485194), a 4mm x 10cm galaxy g3 xsft (glx120410 / 30415769), a 3mm x 8cm galaxy g3 xsft (glx120308 / l14664), and a 2.00mm x 4.00cm galaxy g3 mini (glm920040 / l16385) via an excelsior sl-10 microcatheter (stryker).Two neuroform atlas stents (stryker) were placed for neck remodeling.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 22% 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.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 (30485194) 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 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: 3008114965-2021-00702, 3008114965-2021-00703, 3008114965-2021-00705, 3008114965-2021-00706, and 3008114965-2021-00707.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 Description

The event was reported via the (b)(6) study, a (b)(6) female patient with a history of congestive heart failure (chf), diabetes, controlled hypertension, hypothyroidism, gastroesophageal reflux disease (gerd), sleep apnea, liver cirrhosis, esophageal varices, osteoporosis, idiopathic pulmonary fibrosis (ipf), chronic obstructive pulmonary disease (copd), and class 1 obesity (bmi 30 kg/m2) underwent stent-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm 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 the following day with modified rankin scale (mrs) score of 2, unchanged from baseline.Platelet reactivity testing was not performed.The dimensions of the acom bifurcation aneurysm were as follows: aneurysm height 9.7mm, dome 8.4mm, maximum aneurysm diameter 6.6mm, neck size 3.6mm, and dome-to-neck ratio of 2.3mm.The parent vessel diameter was 3.7mm.Stent-assisted coil embolization was performed with six cerenovus coils: a 10mm x 30cm galaxy g3 (gly121030 / 30386790), a 9mm x 14cm micrusframe 14 (mfr140914 / k10025), a 5mm x 15cm galaxy g3 (gly120515 / 30485194), a 4mm x 10cm galaxy g3 xsft (glx120410 / 30415769), a 3mm x 8cm galaxy g3 xsft (glx120308 / l14664), and a 2.00mm x 4.00cm galaxy g3 mini (glm920040 / l16385) via an excelsior sl-10 microcatheter (stryker).Two neuroform atlas stents (stryker) were placed for neck remodeling.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 22% 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.The complaint coils remain implanted and are thus not available for evaluation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 18-jan-2022.The event was reported via the sterling study, a 76-year-old female patient with a history of congestive heart failure (chf), diabetes, controlled hypertension, hypothyroidism, gastroesophageal reflux disease (gerd), sleep apnea, liver cirrhosis, esophageal varices, osteoporosis, idiopathic pulmonary fibrosis (ipf), chronic obstructive pulmonary disease (copd), and class 1 obesity (bmi 30 kg/m2) underwent stent-assisted coil embolization of an unruptured anterior communicating artery (acom) aneurysm 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 the following day with modified rankin scale (mrs) score of 2, unchanged from baseline.Platelet reactivity testing was not performed.The dimensions of the acom bifurcation aneurysm were as follows: aneurysm height 9.7mm, dome 8.4mm, maximum aneurysm diameter 6.6mm, neck size 3.6mm, and dome-to-neck ratio of 2.3mm.The parent vessel diameter was 3.7mm.Stent-assisted coil embolization was performed with six cerenovus coils: a 10mm x 30cm galaxy g3 (gly121030 / 30386790), a 9mm x 14cm micrusframe 14 (mfr140914 / k10025), a 5mm x 15cm galaxy g3 (gly120515 / 30485194), a 4mm x 10cm galaxy g3 xsft (glx120410 / 30415769), a 3mm x 8cm galaxy g3 xsft (glx120308 / l14664), and a 2.00mm x 4.00cm galaxy g3 mini (glm920040 / l16385) via an excelsior sl-10 microcatheter (stryker).Two neuroform atlas stents (stryker) were placed for neck remodeling.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 22% 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.The complaint coils remain implanted and are thus not available for evaluation.[additional information]: on 18-jan-2022, additional information was received.Per the physician, the two neuroform atlas stents used for y-stenting, and decreased likelihood of coils caused or contributed to the reported thrombosis.The relationship of the study coils to the reported event is deemed as possible.When the thrombus was identified, the physician was just finishing the procedure (stenting and coiling).The thrombus was not flow-limiting; it was non-occlusive.The thrombus 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 or side branch vessel occlusion.The thrombosis did not result in an infarction.Heparin (2000 u), aspirin (300 mg), and clopidogrel (150 mg) were administered as treatment.The event did not require prolonged hospitalization.This is one of 6 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2021-00702, 3008114965-2021-00703, 3008114965-2021-00704, 3008114965-2021-00705, 3008114965-2021-00706, and 3008114965-2021-00707.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 5MM X 15CM
• 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: 13090774
• MDR Text Key: 288296479
• Report Number: 3008114965-2021-00704
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077510
• UDI-Public: 10886704077510
• 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
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: GLY120515
• Device Catalogue Number: GLY120515
• Device Lot Number: 30485194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; GALAXY G3 10MM X 30CM.; GALAXY G3 MINI 2MM X 4CM.; GALAXY G3 XSFT 3MM X 8CM.; GALAXY G3 XSFT 4MM X 10CM.; MICRUSFRAME14 9MMX14CM.; NEUROFORM ATLAS® STENT SYSTEM (STRYKER).; NEUROFORM ATLAS® STENT SYSTEM (STRYKER).
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White