MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 1.5MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM915040
Medical Device Problem Codes	Separation Failure (2547); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the sterling study, a 36-year-old male (subject 01418-003) with no significant medical history underwent coil embolization of a ruptured left middle cerebral artery aneurysm on (b)(6) 2022.Hunt & hess grade score was 1 and modified rankin scale (mrs) score was 0.Discharge information was not provided.Immediate pre-procedure digital subtraction angiography performed on (b)(6) 2022 revealed a ruptured left middle cerebral artery aneurysm with the following dimensions: height 3.3mm, dome 6.9mm, maximum aneurysm diameter 7.0mm, neck size 3.0mm, and dome-to-neck ratio 2.3mm.The parent vessel diameter was 2mm.Per the case report form (crf), the following coils were implanted via an excelsion sl-10 (stryker) microcatheter: one 4mm x 10mm galaxy g3 (gly120410/30550298), one 2mm x 4mm galaxy g3 xtrasoft (glx120204/30371925), one 2mm x 4 cm galaxy g3 mini (glm920040/30392248) and one 1.5mm x 4cm galaxy g3 mini (glm915040/30409519).During coiling of the 1.5mm x 4cm galaxy g3 mini (glm915040/30409519) a coil prolapse/herniation occurred intra-procedure.After the coil was ¿detached¿, when the microcatheter was removed from the sac, the coil was in fact partially detached and was pulled out of the aneurysm, leaving 1 large loop outside.The movement of the microcatheter completed the detachment by inducing more kink on the detachment zone which ruptured after the coil was partially pulled out of the aneurysm, leaving no possibility for coil repositioning.This device deficiency did not result in a device-related sae.A balloon was used, but not implanted.Once complete, the balloon and sl-10 were removed from the guide catheter.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy score of class i: complete (complete obliteration) and angiosuite packing was not done.There was no reported intraoperative aneurysm rupture or thromboembolic event.Platelet reactivity testing was not performed.
Additional Manufacturer Narrative
Product complaint # pc- (b)(4).Patient identifier: cnv_2017_01: 01418-003.Procode: krd/hcg.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Complaint conclusion: as reported by the sterling study, a 36-year-old male (subject 01418-003) with no significant medical history underwent coil embolization of a ruptured left middle cerebral artery aneurysm on (b)(6) 2022.Hunt & hess grade score was 1 and modified rankin scale (mrs) score was 0.Discharge information was not provided.Immediate pre-procedure digital subtraction angiography performed on 09-mar-2022 revealed a ruptured left middle cerebral artery aneurysm with the following dimensions: height 3.3mm, dome 6.9mm, maximum aneurysm diameter 7.0mm, neck size 3.0mm, and dome-to-neck ratio 2.3mm.The parent vessel diameter was 2mm.Per the case report form (crf), the following coils were implanted via an excelsion sl-10 (stryker) microcatheter: one 4mm x 10mm galaxy g3 (gly120410/30550298), one 2mm x 4mm galaxy g3 xtrasoft (glx120204/30371925), one 2mm x 4 cm galaxy g3 mini (glm920040/30392248) and one 1.5mm x 4cm galaxy g3 mini (glm915040/30409519).During coiling of the 1.5mm x 4cm galaxy g3 mini (glm915040/30409519) a coil prolapse/herniation occurred intra-procedure.After the coil was ¿detached¿, when the microcatheter was removed from the sac, the coil was in fact partially detached and was pulled out of the aneurysm, leaving 1 large loop outside.The movement of the microcatheter completed the detachment by inducing more kink on the detachment zone which ruptured after the coil was partially pulled out of the aneurysm, leaving no possibility for coil repositioning.This device deficiency did not result in a device-related sae.A balloon was used, but not implanted.Once complete, the balloon and sl-10 were removed from the guide catheter.Heparin was administered during the procedure.In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy score of class i: complete (complete obliteration) and angiosuite packing was not done.There was no reported intraoperative aneurysm rupture or thromboembolic event.Platelet reactivity testing was not performed.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30409519 number, and no non-conformances related to the malfunction were identified.Coil difficulty to detach and protrusion into parent vessel are known potential complications associated with the use of embolic coils in endovascular embolization of intracranial aneurysms and are listed in the instructions for use (ifu) as such.Review of the available information does not allow for an exact determination of root cause; however, there are clinical and procedural factors, including aneurysm/vessel characteristics, device selection, device interaction, and operator technique, that may have contributed to the reported event rather than the design or manufacture of the device.The alleged product failures could result in non-target site embolization, ischemia or infarct and could have led to non-target site embolization, resulting in ischemia or infarct, or may have require additional intervention.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, g6, g3, h2 and h10.Section b5: additional information was received on 21-jun-2022 indicated that the description of the device deficiency was updated reporting that the coil was partially detached and was pulled out of the aneurysm.The detachment induced more kink on the detachment zone which ruptured leaving no possibility for coil repositioning.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: GALAXY G3 MINI 1.5MM 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14396819
• Report Number: 3008114965-2022-00335
• Device Sequence Number: 5537892
• Product Code: KRD
• UDI-Device Identifier: 10886704080152
• UDI-Public: 10886704080152
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171862
• 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: Foreign,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: GLM915040
• Device Catalogue Number: GLM915040
• Device Lot Number: 30409519
• 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: 04/26/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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: EXCELSION SL-10 (STRYKER) MICROCATHETER; GALAXY G3 4MM X 10CM; GALAXY G3 MINI 2MM X 4CM; GALAXY G3 XSFT HEL 2MM X 4CM; UNSPECIFIED BALLOON CATHETER
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 113 KG