MAUDE Adverse Event Report: REFER TO SECTION H10 GALAXY G3 MINI 3MM X 4CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	GLM930040
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(4).Concomitant med products due to character limitation: 2 mm x 3 cm galaxy g3 mini (glm920030/s15138), enterprise 2 stent (enf402300/unk lot), prowler select lp/es (606-s155x/17687035) microcatheter.Initial reporter first name, phone, fax, and e-mail were not reported.(b)(4).Complaint conclusion: as reported by a healthcare professional, during an enterprise 2 stent-assisted coil embolization of a 4.9 mm x 4.6 mm (4.4 mm neck) left ophthalmic internal carotid artery (ica) aneurysm, the 2 mm x 3 cm galaxy g3 mini (glm920030/s15138) thermo-mechanical coil was advanced to the microcatheter tip in the existing coil mass, but the physician felt the coil was no longer responding to advancement or withdrawal and may have stretched.The prowler lp/es (606-s155x/17687035) microcatheter and coil were pulled back together as a unit from the coil mass.Upon their withdrawal, the proximal 1 cm of the previous 3 mm x 4 cm galaxy g3 mini (glm930040/unk lot) coil came out of the aneurysm.The microcatheter and 2 mm x 3 cm galaxy g3 mini coil were removed from the patient.The embolic coil was still attached to the delivery system when removed from the patient.Angiography was performed and the physician determined that the coil embolization was complete.A 4 mm x 23 mm enterprise 2 stent (enf402300/unk lot) was implanted across the neck of the aneurysm.The sales representative gently removed the coil from the microcatheter and no visible damage was noted to the embolic coil.Reportedly, no additional intervention was performed to address the coil that protruded from the aneurysm and there are no plans to perform additional coil embolization at a later date.The coil was left in place to endothelialize.There was no evidence of thrombus formation at the site of the protruded coil and no sign of flow restriction/reduction.The surgery was delayed five minutes due to the event.The sales representative indicated that the exact issue remains unclear but the event may have been related to coil entanglement.The suspected cause of coil entanglement was not reported.No visible product damage was noted prior to the event.The devices were stored, handled, and prepped according to the instructions for use (ifu).The coil delivery systems were prepped without any difficulty.There was no resistance between the guidewire and microcatheter when accessing the target site.Prior to the 2 mm x 3 cm galaxy g3 mini coil, five coils went through the same microcatheter without resistance.No resistance was encountered during advancement of the through the microcatheter.An adequate continuous flush was maintained through the microcatheter.The microcatheter was not repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.A one-to-one relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning.The microcoil was not positioned at a relative sharp angle to the microcatheter.The user did not apply excessive force at any time during the case.No further information was provided.The 3 mm x 4 cm galaxy g3 mini remains implanted in the patient and is thus not available for analysis.Additionally, the sterile lot number is not known.No further analysis can be performed for complaints reported without a lot number and for which the associated products will not be returned.With the information available and without the product available for analysis, the reported customer complaint that the coil protruded into the parent vessel post-detachment could not be confirmed.In addition, the complaint of coil - protrusion into parent vessel is specific to the operational context and cannot be evaluated in the lab.Without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.Coil prolapse into the parent vessel is a known procedural complication associated with the thermo-mechanical coil family and coil embolization procedures.Recent advancements in vascular reconstruction devices and coils have allowed for the application of coil embolization for even relatively wide-neck aneurysms.Despite tight coil packing, protrusion of coil segments out of the aneurysm and into the parent artery still occurs.The root cause cannot be conclusively determined; however, it is possible that the aneurysm neck size/vessel characteristics, coil entanglement/device interaction, and circumstances of the procedure may have contributed to the reported event.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.This is one of three products involved with the reported complaint and the associated manufacturer report numbers are 3008114965-2018-00678, this report, and 1226348-2018-00649.
Event or Problem Description
As reported by a healthcare professional, during an enterprise 2 stent-assisted coil embolization of a 4.9 mm x 4.6 mm (4.4 mm neck) left ophthalmic internal carotid artery (ica) aneurysm, the 2 mm x 3 cm galaxy g3 mini (glm920030/s15138) thermo-mechanical coil was advanced to the microcatheter tip in the existing coil mass, but the physician felt the coil was no longer responding to advancement or withdrawal and may have stretched.The prowler lp/es (606-s155x/17687035) microcatheter and coil were pulled back together as a unit from the coil mass.Upon their withdrawal, the proximal 1 cm of the previous 3 mm x 4 cm galaxy g3 mini (glm930040/unk lot) coil came out of the aneurysm.The microcatheter and 2 mm x 3 cm galaxy g3 mini coil were removed from the patient.The embolic coil was still attached to the delivery system when removed from the patient.Angiography was performed and the physician determined that the coil embolization was complete.A 4 mm x 23 mm enterprise 2 stent (enf402300/unk lot) was implanted across the neck of the aneurysm.The sales representative gently removed the coil from the microcatheter and no visible damage was noted to the embolic coil.Reportedly, no additional intervention was performed to address the coil that protruded from the aneurysm and there are no plans to perform additional coil embolization at a later date.The coil was left in place to endothelialize.There was no evidence of thrombus formation at the site of the protruded coil and no sign of flow restriction/reduction.The surgery was delayed five minutes due to the event.The sales representative indicated that the exact issue remains unclear but the event may have been related to coil entanglement.The suspected cause of coil entanglement was not reported.No visible product damage was noted prior to the event.The devices were stored, handled, and prepped according to the instructions for use (ifu).The coil delivery systems were prepped without any difficulty.There was no resistance between the guidewire and microcatheter when accessing the target site.Prior to the 2 mm x 3 cm galaxy g3 mini coil, five coils went through the same microcatheter without resistance.No resistance was encountered during advancement of the through the microcatheter.An adequate continuous flush was maintained through the microcatheter.The microcatheter was not repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.A one-to-one relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning.The microcoil was not positioned at a relative sharp angle to the microcatheter.The user did not apply excessive force at any time during the case.The 3 mm x 4 cm galaxy g3 mini remains implanted in the patient and is thus not available for analysis.No further information was provided.

• Brand Name: GALAXY G3 MINI 3MM X 4CM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7686566
• Report Number: 3008114965-2018-00679
• Device Sequence Number: 16493367
• Product Code: KRD
• UDI-Device Identifier: 10886704080329
• UDI-Public: 10886704080329
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K171862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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 Catalogue Number: GLM930040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1