MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GALAXY G3 XSFT HEL 2MM X 8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number GLX120208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ruptured Aneurysm (4436)

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Patient identifier - (b)(6).Date of death ¿ not reported.Procode: krd/hcg.Lot: the lot number was not reported.Initial reporter phone: is (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of eight products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00723, 3008114965-2021-00724, 3008114965-2021-00726, 3008114965-2021-00727, 3008114965-2021-00728, 3008114965-2021-00729 and 3008114965-2021-00730.

Event Description

As reported via the (b)(6) study, a (b)(6) male patient (subject (b)(6)) with a past medical history of coronary artery disease (cad), renal insufficiency, smoking (previous), and atherosclerosis underwent endovascular coil embolization of an infrarenal 53.6 mm abdominal aortic aneurysm (aaa) on an unknown date and expired secondary to aaa rupture 300 days following the procedure.The study procedure was reintervention after abdominal endovascular aneurysm repair (evar) of aaa for endoleak repair.The etiology of the aaa was atherosclerosis.The study procedure occurred 2,582 days after the initial evar of aaa.A total of 8 spectra (cerenovus) coils were implanted at the lumbar artery: three 2 mm x 2 cm galaxy g3 xsft (glx120202/unknown lot number), two 2 mm x 4 cm galaxy g3 xsft hel (glx120204/unknown lot number), and three 2 mm x 8 cm galaxy g3 xsft hel (glx120208/unknown lot number).Fluoroscopy time was 33 minutes.There were no reported procedural complications.The coil embolization was considered successful.The patient was hospitalized four days.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via the aaa study, a 79-year-old male patient (subject (b)(6)) with a past medical history of coronary artery disease (cad), renal insufficiency, smoking (previous), and atherosclerosis underwent endovascular coil embolization of an infrarenal 53.6mm abdominal aortic aneurysm (aaa) on an unknown date and expired secondary to aaa rupture 300 days following the procedure.The study procedure was reintervention after abdominal endovascular aneurysm repair (evar) of aaa for endoleak repair.The etiology of the aaa was atherosclerosis.The study procedure occurred 2,582 days after the initial evar of aaa.A total of 8 spectra (cerenovus) coils were implanted at the lumbar artery: three 2mm x 2cm galaxy g3 xsft (glx120202/unknown lot number), two 2mm x 4cm galaxy g3 xsft hel (glx120204/unknown lot number), and three 2mm x 8cm galaxy g3 xsft hel (glx120208/unknown lot number).Fluoroscopy time was 33 minutes.There were no reported procedural complications.The coil embolization was considered successful.The patient was hospitalized four days.No further information is available.The device was implanted; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Aneurysm rupture leading to death is a known potential adverse event associated with coil embolization procedures and is listed in the spectra coil instructions for use (ifu) as such.Persistent endoleak and sac pressurization are among the possible mechanisms of aaa rupture after evar.With the information provided, the root cause of the event cannot be determined.However, there are patient and procedural factors that may have contributed to the reported event.There is no indication that the coils malfunctioned or that it is related to the device design or manufacturing process.The relationship of the coils to the fatal aneurysm rupture cannot be excluded.The file will be re-reviewed if additional information is received at a later date.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.

• Brand Name: GALAXY G3 XSFT HEL 2MM X 8CM
• Type of Device: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13025372
• MDR Text Key: 282392040
• Report Number: 3008114965-2021-00725
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077763
• UDI-Public: 10886704077763
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLX120208
• Device Catalogue Number: GLX120208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GALAXY G3 XSFT 2MM X 2CM; GALAXY G3 XSFT HEL 2MM X 4CM; GALAXY G3 XSFT HEL 2MM X 4CM; GALAXY G3 XSFT HEL 2MM X 8CM; GALAXY G3 XSFT HEL 2MM X 8CM
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male