BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 XSFT 2MM X 2CM

    MDR report key: 8888171 · Received August 13, 2019

    Report

    Report Number
    3008114965-2019-01133
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    July 19, 2019
    Report Date
    July 20, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077640
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2019. UPON REVIEW OF THE OPERATIVE REPORT, ONLY TWO OF THE FOUR GALAXY G3 XSFT COILS (4MM X 10CM & 2.5MM X 3.5CM) HAD BEEN INTRODUCED INTO THE PATIENT AT THE TIME OF THE ANEURYSM RUPTURE; THEREFORE, THE TWO REMAINING COILS (2MM X 2CM) TO DO NOT MEET THE CRITERIA FOR MEDICAL DEVICE REPORTING SINCE THE COILS WERE NOT IN THE PATIENT WHEN THE EVENT OCCURRED. NO FURTHER REPORTS WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT OF ANEURYSM RUPTURE WAS NOT EXPECTED BY THE INVESTIGATOR. COMPLAINT CONCLUSION: AS REPORTED BY THE STERLING STUDY, A 46-YEAR OLD FEMALE (PATIENT 992-010), WITH A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, CHRONIC BACK PAIN, PANIC ATTACKS, AND BREAST CANCER UNDERWENT COIL EMBOLIZATION OF A MIDLINE ANTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED SEVERE INTRAOPERATIVE ANEURYSM RUPTURE. HEPARIN REVERSAL WAS PERFORMED WITH THE ADMINISTRATION OF PROTAMINE SULFATE AND PLATELETS. IT WAS LAST REPORTED THAT THE PATIENT IS RECOVERING FROM THE EVENT. THE PRIMARY INVESTIGATOR FELT THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE (S). ON (B)(6) -2019, ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY BIFURCATION. THE ANEURYSM HEIGHT WAS 6.6MM AND DOME WAS 6.3MM. THE MAXIMUM ANEURYSM DIAMETER WAS 6.6MM, NECK SIZE WAS 2.8MM AND DOME-TO-NECK RATIO WAS 2.3MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XTRASOFT, ONE 2.5MM X 3.5CM GALAXY G3 XTRASOFT, TWO 2.0MM X 2.0CM GALAXY G3 XTRASOFT, AND SEVEN COMPETITOR COILS VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE PATIENT SUFFERED FROM AN INTRAOPERATIVE ANEURYSM RUPTURE, WHICH WAS CONSIDERED BY THE INVESTIGATOR WAS POSSIBLY RELATED TO THE STUDY DEVICE (S). THE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS II (RESIDUAL NECK); HOWEVER, IN THE OPINION OF THE INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE. NO FURTHER INFORMATION WAS REPORTED IN THE CASE REPORT FORM (CRF). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ANEURYSM RUPTURE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH COIL EMBOLIZATION AND IS LISTED IN THE IFU AS SUCH. MANIPULATION OF DEVICES IN OR NEAR THE INTRACRANIAL ANEURYSM INCREASES THE RISK OF RUPTURING THE FRAGILE ANEURYSM WALL. BASED ON THE MINIMAL INFORMATION AVAILABLE REPORTED IN THE CRF, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. MULTIPLE ATTEMPTS TO OBTAIN OPERATIONAL NOTES AND DISCHARGE NOTES HAVE BEEN UNSUCCESSFUL. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). PATIENT IDENTIFIER: (B)(6). PROCODE: KRD/HCG. MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2019-01131, 3008114965-2019-01132 AND 2954740-2019-00546. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    AS REPORTED BY THE STERLING STUDY, A (B)(6) YEAR OLD FEMALE (PATIENT 992-010), WITH A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, CHRONIC BACK PAIN, PANIC ATTACKS, AND BREAST CANCER UNDERWENT COIL EMBOLIZATION OF A MIDLINE ANTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED SEVERE INTRAOPERATIVE ANEURYSM RUPTURE. HEPARIN REVERSAL WAS PERFORMED WITH THE ADMINISTRATION OF PROTAMINE SULFATE AND PLATELETS. IT WAS LAST REPORTED THAT THE PATIENT IS RECOVERING FROM THE EVENT. THE PRIMARY INVESTIGATOR FELT THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE (S). ON (B)(6) 2019, ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY BIFURCATION. THE ANEURYSM HEIGHT WAS 6.6MM AND DOME WAS 6.3MM. THE MAXIMUM ANEURYSM DIAMETER WAS 6.6MM, NECK SIZE WAS 2.8MM AND DOME-TO-NECK RATIO WAS 2.3MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XTRASOFT, ONE 2.5MM X 3.5CM GALAXY G3 XTRASOFT, TWO 2.0MM X 2.0CM GALAXY G3 XTRASOFT, AND SEVEN COMPETITOR COILS VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE PATIENT SUFFERED FROM AN INTRAOPERATIVE ANEURYSM RUPTURE, WHICH WAS CONSIDERED BY THE INVESTIGATOR WAS POSSIBLY RELATED TO THE STUDY DEVICE (S). THE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS II (RESIDUAL NECK); HOWEVER, IN THE OPINION OF THE INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE. NO FURTHER INFORMATION WAS REPORTED IN THE CASE REPORT FORM (CRF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682846 GALAXY G3 XSFT 2MM X 2CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL L13229 10886704077640

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R 0.025 TERUMO GUIDEWIRE| ENVOY 6F, MPD 100CM| EXCELSIOR SL10 MICROCATHETER| SYNCHRO 2 SOFT MICROWIRE| EXCELSIOR SL10 MICROCATHETER