MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 2.5MM X 5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLY122505

Device Problem Migration (4003)

Patient Problems Stroke/CVA (1770); Death (1802); Intracranial Hemorrhage (1891)

Event Date 08/24/2020

Event Type  Death  

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.The date of death was not reported.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.A review of manufacturing documentation associated with this lot (l13317) 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.Microcoil migration away from the aneurysm and death are known potential complications associated with coil embolization procedures.With the amount of information available and without films of the event, it is not possible to draw a conclusion between the device and the reported event.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 coil migration may result in a non-target site embolization, ischemia, or infarct, and may require additional intervention.The relationship of the device to the reported death cannot be excluded based on the initial information available.The file will be re-reviewed if the additional information is received at a later date.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2020-00438 and 3008114965-2020-00439.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 healthcare professional reported that during a procedure on (b)(6) 2020, two coils (a 2.5mm x 5cm galaxy g3 coil: gly122505 / l13317 and a 1.5mm x 2cm deltaxsft 10 coil: dlx100152 / k10051) became dislodged from the aneurysm during the procedure and migrated into other vascular territories.The patient had since expired but it is unknown if this incident caused or contributed to the fatal outcome.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to make a correction to the investigation conclusions.Corrected section: h.6 updated sections: g.3, g.6, h.2, h.6, h.10, and h.11.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are (b)(4).And (b)(4).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.H.6: investigation conclusions.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 30 november 2020.[conclusion]: the healthcare professional reported that during a procedure on (b)(6) 2020, two coils (a 2.5mm x 5cm galaxy g3 coil: gly122505 / l13317 and a 1.5mm x 2cm deltaxsft 10 coil: dlx100152 / k10051) became dislodged from the aneurysm during the procedure and migrated into other vascular territories.The patient had since expired but it is unknown if this incident caused or contributed to the fatal outcome.On 30 november 2020, additional information was received from the physician.The information indicated that the procedure on (b)(6) 2020 was targeting a recurrent aneurysm that was previously coiled on (b)(6) 2009.The target aneurysm was a 4.2mm x 2.7mm broad based recurrence anteriorly pointing nipple located on the anterior communicating artery (acom).Day 2, the patient had a wfns (world federation of neurosurgical societies): 4-5, and fischer scale grade 4 sah.Both coils became dislodged into the a2 segment of the anterior cerebral artery (aca).The physician was unable to get the larger coil and unable to cannulate the left a2 and left the smaller coil.There was no additional intervention performed to reposition the dislodged coils in the aneurysm or secure the detached coils to the vessel wall.The coils ended up in the right pericallosal and left a2 segment.The patient expired on (b)(6) 2020.The physician stated that he ¿does not have the death certificate to hand in, but the cause of death is likely to be sah and stroke.¿ per the physician, the dislodged coils may have contributed to the patient¿s death, but the patient ¿had poor grade sah and may have died anyway.¿ based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot: (l13317) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances 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.Microcoil migration away from the aneurysm and death are known potential complications associated with coil embolization procedures.With the amount of information available and without films of the event, it is not possible to draw a definite conclusion between the device and the reported event.However, there are clinical and procedural factors, including aneurysm / vessel characteristics, device selection, device interaction, and operator technique, that may have contributed rather than the design or manufacture of the device.Furthermore, the physician suspected that the dislodged coils could have contributed to the patient¿s death however he did indicate that ¿the patient had a poor grade sah and may have died anyway¿.The alleged coil migration meets mdr reporting criteria as a ¿malfunction¿ since this failure could result in non-target site embolization, ischemia, or infarct, and may require additional intervention.Since the event resulted in a serious health deterioration of the patient and his eventual death and since the relationship of the device to the reported event cannot be excluded; the event is considered mdr reportable with the classification of ¿death¿ for both complaint coils.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.H.6: component code: appropriate term/code not available (g07002) was used as there are no findings available because device was not returned.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2020-00439.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 24 march 2021.This mdr submission also includes a revision / correction of the health effect ¿ clinical code.On (b)(6) 2021, procedure imaging was received.The images underwent independent physician review on the same day.The results are as follows: "a series of ap and lateral oblique images are provided accompanied by a description of the procedure and event.There are 6 sets of images (ap/lat oblique projections) pre coiling, post first coil, post second coil, post second coil migration, post first coil migration and final coil migration images.There is a previously coiled acom aneurysm with a moderate 4-5 wide necked recurrence at the base of the aneurysm along with a sausage shaped pseudoaneurysm projecting anteriorly.On images two and three there has been interval placement of 2.5 mm x 5 cm galaxy g3 and a 1.5 mm x 2 cm deltasoft coil into the pseudoaneurysm.Images 4 shows migration of the deltasoft coil into the rt.A2 and image 5 migration of the g3 into the base of the aneurysm.Image 6 shows migration of the g3 into the left a2 and occlusion of the rt callosal marginal branch of the aca likely from the migrated deltasoft coil.There is no accompanying information or video loops to document if the physician thought the coils were in a stable position.Also, there is no presence of a balloon or stent across the wide neck aneurysm.Image 2 (post coil1) shows a random configuration of the coil loops with a few loops in the main aneurysm recurrence base and on image 3 (post coil 2) shows that the deltasoft coil is more towards the base and does not appear to be intertwined with coil loops at the dome of the pseudoaneurysm likely representing an unstable coil mass configuration.It is likely that upon detachment given the poor coil integration, large aneurysm base and flow in the aneurysm that the second coil dislodged followed by pulling of the first coil into the aneurysm base which then became unstable given the broad nature of the aneurysm and flow and was further dislodged in the left a2.These events likely occurred because of poor initial coil placement however it is impossible to say without fluoro loops showing the stability or instability of the coil mass.Given the patient's poor initial wfns grade at presentation, the patient likely expired from the sah.Without a follow up ct to show infarcts in the aca distributions (potentially caused by the migrated coils) it is impossible to state if the migrated coils contributed to the patient's demise." physician name and date reviewed: (b)(6)2021.Microcoil migration away from the aneurysm, stroke, and death are known potential complications associated with coil embolization procedures.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors, including aneurysm/vessel characteristics (i.E., wide neck), anatomical challenges, device selection, device interaction, and operator technique, that may have contributed rather than the design or manufacture of the device.Furthermore, the physician suspected that the dislodged coils could have contributed to the patient¿s death however he did indicate that ¿the patient had a poor grade sah and may have died anyway¿.The alleged coil migration meets mdr reporting criteria as a ¿malfunction¿ since this failure could result in non-target site embolization, ischemia, or infarct, and may require additional intervention.Since the device failures appear to have resulted in a serious health deterioration of the patient and his eventual death, the event is considered mdr reportable with the classification of ¿death¿ for both complaint coils.Corrected section: h.6.The health effect ¿ clinical code ¿intracranial hemorrhage¿ was revised / corrected to ¿stroke/cva¿.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are 3008114965-2020-00438 and 3008114965-2020-00439.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.H.6.The health effect ¿ clinical code ¿intracranial hemorrhage¿ was revised / corrected to ¿stroke/cva¿.

• Brand Name: GALAXY G3 2.5MM X 5CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10678927
• MDR Text Key: 211330332
• Report Number: 3008114965-2020-00438
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077411
• UDI-Public: 10886704077411
• Combination Product (y/n): N
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: GLY122505
• Device Catalogue Number: GLY122505
• Device Lot Number: L13317
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 11/30/2020; 12/10/2020; 03/24/2021
• Supplement Dates FDA Received: 12/08/2020; 12/10/2020; 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTAXSFT10 1.5MM X 2CM; DELTAXSFT10 1.5MM X 2CM
• Patient Outcome(s): Death
• Patient Age: 74 YR