MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	GLX120306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Lot: the lot number is not reported.Initial reporter phone: (b)(6).This is one of five products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00310, 3008114965-2022-00311, 3008114965-2022-00313 and 3008114965-2022-00314.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that a patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an unruptured basilar tip aneurysm and experienced intraoperative aneurysm rupture.Details of the procedure: a 6f shuttle sheath was inserted via the femoral artery and delivered to the vertebral artery (va).A 6f sofia plus catheter (microvention) was then delivered to the proximal basilar artery as a distal access catheter (dac).The pulserider 10t, 2.7 ¿ 3.5mm anrd (211d/3056488803) was deployed via a prowler select plus microcatheter (606s255x/30250996), but torque was not applied well.The pulse rider direction was not proper, and the direction was adjusted by applying torque while retracting the device into the prowler select plus microcatheter.This was attempted three times, but the orientation did not change.The physician removed the pulserider from the patient once and reinserted into the prowler select plus microcatheter.The prowler select plus was replaced with a headway 27 microcatheter (microvention) because the complaint microcatheter did not orient in the same way when deployed and did not change even when torque was applied in the same way.When torque was applied to the headway 27 in the same way, the direction changed and the pulserider could be deployed as intended.Headway duo microcatheter (microvention) was then implanted via trans-cell technique.Coil embolization was started with a 5mm x 15cm galaxy g3 (gly120515/unknown lot number), a 4mm x 6cm galaxy g3 xsft (glx120406/unknown lot number), a 3mm x 6cm galaxy g3 xsft (glx120306/unknown lot number), and two 2mm x 4cm galaxy g3 mini (glm920040/30666652, 30415753).However, the aneurysm ruptured and "there was bleeding by using coil(s)".Heparin reversal was performed.The pulserider was detached, and the headway 27 was removed.The transform balloon catheter (stryker) was delivered to the basilar artery and inflation was done.Two coils (1mm x 2cm axium medtronic and 1mm x 2cm galaxy g3 mini) were implanted.Hemostasis was confirmed by angiography.The patient was monitored for ten minutes.Angiography was repeated, and hemostasis was confirmed so the procedure was completed.The patient was transferred to the intensive care unit (icu) under anesthesia.No additional treatment will be performed.The treating physician commented "when this event occurred, there was almost no resistance during coil insertion.Because the physician was holding the microcatheter down, the microcatheter may have entered the deep part of the aneurysm." the event was considered non-serious (moderate/minimal).It was further reported that "it is still difficult to say anything without observing neurological symptoms after awakening from anesthesia, but the amount of bleeding was small." the devices were allegedly used as per the instructions for use (ifu).Continuous flush was done.Additional information received indicated that the physician did not consider the prowler select plus microcatheter and pulserider anrd to be related to the aneurysm rupture.The patient did not experience any clinical symptoms due to the aneurysm rupture.The device remains implanted; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Aneurysm perforation is a known potential adverse event associated with coil embolization procedures.Manipulation of devices in or near the intracranial aneurysm increases the risk of rupturing the fragile aneurysm wall.With the information provided, it is not possible to draw a clinical conclusion between the devices and the reported aneurysm perforation.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device manipulation, device interaction, device selection, and operator technique that may have contributed rather than the design or manufacture of the devices.There is no report of a device malfunction or defect.The aneurysm perforation required surgical intervention to achieve hemostasis and preclude permanent impairment and damage.Furthermore, the relationship of the five cerenovus coils to the aneurysm perforation cannot be excluded (i.E., the aneurysm perforation occurred at the time of coiling).This complaint will be reassessed if new information becomes available.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.
Event or Problem Description
It was reported by a healthcare professional that a patient underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of an unruptured basilar tip aneurysm and experienced intraoperative aneurysm rupture.Details of the procedure: a 6f shuttle sheath was inserted via the femoral artery and delivered to the vertebral artery (va).A 6f sofia plus catheter (microvention) was then delivered to the proximal basilar artery as a distal access catheter (dac).The pulserider 10t, 2.7 ¿ 3.5mm anrd (211d/3056488803) was deployed via a prowler select plus microcatheter (606s255x/30250996), but torque was not applied well.The pulse rider direction was not proper, and the direction was adjusted by applying torque while retracting the device into the prowler select plus microcatheter.This was attempted three times, but the orientation did not change.The physician removed the pulserider from the patient once and reinserted into the prowler select plus microcatheter.The prowler select plus was replaced with a headway 27 microcatheter (microvention) because the complaint microcatheter did not orient in the same way when deployed and did not change even when torque was applied in the same way.When torque was applied to the headway 27 in the same way, the direction changed and the pulserider could be deployed as intended.Headway duo microcatheter (microvention) was then implanted via trans-cell technique.Coil embolization was started with a 5mm x 15cm galaxy g3 (gly120515/unknown lot number), a 4mm x 6cm galaxy g3 xsft (glx120406/unknown lot number), a 3mm x 6cm galaxy g3 xsft (glx120306/unknown lot number), and two 2mm x 4cm galaxy g3 mini (glm920040/30666652, 30415753).However, the aneurysm ruptured and "there was bleeding by using coil(s)".Heparin reversal was performed.The pulserider was detached, and the headway 27 was removed.The transform balloon catheter (stryker) was delivered to the basilar artery and inflation was done.Two coils (1mm x 2cm axium medtronic and 1mm x 2cm galaxy g3 mini) were implanted.Hemostasis was confirmed by angiography.The patient was monitored for ten minutes.Angiography was repeated, and hemostasis was confirmed so the procedure was completed.The patient was transferred to the intensive care unit (icu) under anesthesia.No additional treatment will be performed.The treating physician commented "when this event occurred, there was almost no resistance during coil insertion.Because the physician was holding the microcatheter down, the microcatheter may have entered the deep part of the aneurysm." the event was considered non-serious (moderate/minimal).It was further reported that "it is still difficult to say anything without observing neurological symptoms after awakening from anesthesia, but the amount of bleeding was small." the devices were allegedly used as per the instructions for use (ifu).Continuous flush was done.Additional information received indicated that the physician did not consider the prowler select plus microcatheter and pulserider anrd to be related to the aneurysm rupture.The patient did not experience any clinical symptoms due to the aneurysm rupture.

• Brand Name: GALAXY G3 XSFT 3MM X 6CM
• 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 ; 6465917981
• MDR Report Key: 14270035
• Report Number: 3008114965-2022-00312
• Device Sequence Number: 5907768
• Product Code: KRD
• UDI-Device Identifier: 10886704077695
• UDI-Public: 10886704077695
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GLX120306
• Device Catalogue Number: GLX120306
• 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: 04/11/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 1MM X 2CM AXIUM MEDTRONIC; 1MM X 2CM GALAXY G3 MINI; 6F SHUTTLE SHEATH; 6F SOFIA PLUS CATHETER (MICROVENTION); GALAXY G3 MINI 2MM X 4CM; GALAXY G3 MINI 2MM X 4CM; GALAXY G3 XSFT 4MM X 6CM; HEADWAY 27 MICROCATHETER (MICROVENTION); HEADWAY DUO MICROCATHETER (MICROVENTION); PROWLER SELECT PLUS 150/5CM; PULSERIDER T, 3MM, 10MM ARCH; TRANSFORM BALLOON CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown