MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 MINI 2MM X 4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLM920040
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a cerebral aneurysm stent-assisted coil embolization procedure with a 4.7mm x 5.4mm aneurysm on the vertebral artery-posterior inferior cerebella artery (va-pica), a system approached was made to the lesion without any problem.A neuroform atlas® stent system (stryker) was implanted to start the coil embolization.The first coil used was a 4 mm x 8 cm target® soft coil (stryker) followed by a 3.5mm x 7.5cm galaxy g3 xsft coil as the second coil.The complaint coil, a 2.00mm x 4.00cm galaxy g3 mini coil (glm920040 / 30407099) was used as the third coil.Preparation was completed as per the instructions for use (ifu).The complaint coil began to wind out of the target lesion.The physician thought that the position of the concomitant sl-10® microcatheter (stryker) was not proper, and therefore, an attempt to resheath the coil was made but the sheath became damaged.The complaint coil was replaced with a 2.5mm x 2.5cm galaxy g3 xsft coil.A 1.5mm x 2cm target® nano¿ coil (stryker) was used and the procedure was completed without further issue.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30407099) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Coil herniation is a known potential complication associated with the galaxy g3 mini coil.With the limited information provided in the complaint and without the product available for analysis, the reported issue as related to the complaint coil during the procedure cannot be confirmed.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.Review of the available information does not allow for an exact determination of the 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.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.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 healthcare professional reported that during a cerebral aneurysm stent-assisted coil embolization procedure with a 4.7mm x 5.4mm aneurysm on the vertebral artery-posterior inferior cerebella artery (va-pica), a system approached was made to the lesion without any problem.A neuroform atlas® stent system (stryker) was implanted to start the coil embolization.The first coil used was a 4 mm x 8 cm target® soft coil (stryker) followed by a 3.5mm x 7.5cm galaxy g3 xsft coil as the second coil.The complaint coil, a 2.00mm x 4.00cm galaxy g3 mini coil (glm920040 / 30407099) was used as the third coil.Preparation was completed as per the instructions for use (ifu).The complaint coil began to wind out of the target lesion.The physician thought that the position of the concomitant sl-10® microcatheter (stryker) was not proper, and therefore, an attempt to resheath the coil was made but the sheath became damaged.The complaint coil was replaced with a 2.5mm x 2.5cm galaxy g3 xsft coil.A 1.5mm x 2cm target® nano¿ coil (stryker) was used and the procedure was completed without further issue.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to include the additional event information received on 27 may 2021.E.1: the initial reporter phone: +(b)(6).[additional information]: the healthcare professional reported that during a cerebral aneurysm stent-assisted coil embolization procedure with a 4.7mm x 5.4mm aneurysm on the vertebral artery-posterior inferior cerebella artery (va-pica), a system approached was made to the lesion without any problem.A neuroform atlas® stent system (stryker) was implanted to start the coil embolization.The first coil used was a 4 mm x 8 cm target® soft coil (stryker) followed by a 3.5mm x 7.5cm galaxy g3 xsft coil as the second coil.The complaint coil, a 2.00mm x 4.00cm galaxy g3 mini coil (glm920040 / 30407099) was used as the third coil.Preparation was completed as per the instructions for use (ifu).The complaint coil began to wind out of the target lesion.The physician thought that the position of the concomitant sl-10® microcatheter (stryker) was not proper, and therefore, an attempt to resheath the coil was made but the sheath became damaged.The complaint coil was replaced with a 2.5mm x 2.5cm galaxy g3 xsft coil.A 1.5mm x 2cm target® nano¿ coil (stryker) was used and the procedure was completed without further issue.There was no report of any patient adverse event or complication.On 27 may 2021, additional information was received indicated that excessive force was not applied during the attempt to resheath the complaint device.Updated sections: e.1, e.3, g.3, g.6.H.2, and h.10.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 MINI 2MM 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
• MDR Report Key: 11798885
• Report Number: 3008114965-2021-00168
• Device Sequence Number: 1020485
• Product Code: KRD
• UDI-Device Identifier: 10886704080305
• UDI-Public: 10886704080305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: GLM920040
• Device Catalogue Number: GLM920040
• Device Lot Number: 30407099
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.5 MM X 2 CM TARGET® NANO¿ COIL (STRYKER); 4 MM X 8 CM TARGET® SOFT COIL (STRYKER); GALAXY G3 XSFT 2.5MM X 2.5CM; GALAXY G3 XSFT 3.5MM X 7.5CM; NEUROFORM ATLAS® STENT SYSTEM (STRYKER); SL-10® MICROCATHETER (STRYKER)