BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY G3 MINI 1MM X 2.5CM

    MDR report key: 8153737 · Received December 11, 2018

    Report

    Report Number
    3008114965-2018-00822
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 26, 2018
    Report Date
    November 26, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    UDI-DI
    10886704080220
    PMA / PMN Number
    K171862
    Adverse Event
    Yes
    Product Problem
    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 SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY CERENOVUS PRODUCT ANALYSIS LAB ON 1/11/2019. THE RETURNED PRODUCT IS PENDING EVALUATION; WHEN THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO DOCUMENT THE INVESTIGATION RESULT OF THE EVALUATION PERFORMED ON THE RETURNED PRODUCT. UPDATED SECTIONS: PMA/510K, IF FOLLOW-UP, WHAT TYPE AND DEVICE EVALUATED BY MFR. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THAT TARGETED AN UNRUPTURED 5 MM ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH A 3.8MM NECK SIZE, AFTER THE 1.0MM X 2.5CM GALAXY G3 MINI COIL (GLM910025 / L12957) WAS DELIVERED VIA THE PHENOM¿ .017 MICROCATHETER (MEDTRONIC) AND SUCCESSFULLY DETACHED AT THE TARGET LESION, THE MICROCATHETER AND THE DELIVERY WIRE HERNIATED FROM THE ANEURYSM AND THE A1 SEGMENT INTO THE M1 SEGMENT UPON THE REMOVAL OF THE DELIVERY WIRE. A LOOP OF THE COIL WAS PULLED BACK INTO THE PARENT ARTERY AND RESULTED IN A THROMBUS FORMATION. INTEGRILIN WAS ADMINISTERED AS AN INTERVENTION TO CLEAR THE CLOT AROUND THE COIL LOOP. IT WAS REPORTED THAT THERE WAS NO TREATMENT FOR THE COIL LOOP THAT WAS PULLED INTO THE PARENT ARTERY. THE VESSEL TORTUOSITY WAS REPORTED TO BE LOW. THE CONCOMITANT PRODUCTS THAT WERE USED IN THE PROCEDURE INCLUDED THE ATLAS¿ STENT (STRYKER), 5X10 HYDROFRAME® HYDROGEL FRAMING COIL (MICROVENTION), AND TWO SPECTRA COILS. THE STENT HAD BEEN IMPLANTED WHEN THE REPORTED EVENT OCCURRED, AND IT REMAINED WELL OPPOSED TO THE VESSEL WALL WITH GOOD NECK COVERAGE. THERE WAS NO EVIDENCE OF DISTAL THROMBUS EMBOLIZATION. THE DELIVERY WIRE WAS SUCCESSFULLY RETRIEVED INTO THE MICROCATHETER AND WAS REMOVED FROM THE PATIENT WITHOUT PATIENT INJURY OR ANY ADDITIONAL INTERVENTION. THE ANEURYSM WAS SUCCESSFULLY TREATED. THE PATIENT WAS REPORTED TO BE ¿FINE¿ AFTER THE PROCEDURE. THERE WAS A REPORT OF A 30-MINUTE DELAY IN THE PROCEDURE, BUT THIS WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT. THE 1.0MM X 2.5CM GALAXY G3 MINI COIL WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE RETURN ORDER LABELS CONFIRMED THAT THE GALAXY G3 MINI 1MM X 2.5CM WAS THE REPORTABLE COMPLAINT UNIT OF (B)(4). THE COMPLAINT UNITS WERE RETURNED IN THE SAME PACKAGE WITH NO IDENTIFICATION. NO EMBOLIC COILS WERE SEEN ATTACHED TO ANY OF THE DEVICES OR RETURNED IN THE RECEIVED PACKAGE. A CONCOMITANT PHENOM MICROCATHETER WAS RETURNED WITH THE COMPLAINT UNITS. NO EXTERNAL DAMAGE WAS OBSERVED ON THE PHENOM MICROCATHETER. A LAB SV-5 GUIDEWIRE WAS INSERTED COMPLETELY THROUGH THE MICROCATHETER AND NO RESISTANCE WAS FELT. THERE WAS EMBOLIC COIL ATTACHED TO THE DISTAL END OF THE DEVICE POSITIONING UNIT (DPU) OF THE RETURNED DEVICE. THE INTRODUCER HAD BEEN MOVED DISTALLY SO THAT THE PROXIMAL END OF THE INTRODUCER WAS SEEN POSITIONED INSIDE THE DISTAL ¿ZIPPER¿ SECTION OF THE RESHEATHING TOOL. THE DPU CORE WIRE WAS SEEN PROTRUDING FROM THE DISTAL END OF THE INTRODUCER SKIVE AND WAS EXPOSED FOR THE REMAINDER OF ITS LENGTH. KINKS WERE OBSERVED ON THE DEVICE POSITIONING UNIT (DPU) CORE WIRE AT APPROXIMATELY 65 CM FROM THE PROXIMAL END OF THE DEVICE. THE DISTAL, FLEXIBLE END OF THE DPU CORE WIRE WAS ALSO SEEN KINKED IN MULTIPLE PLACES. THE DEVICE WAS THEN INSPECTED UNDER A MICROSCOPE. THE DISTAL OUTER SHEATH WAS OBSERVED TO HAVE BEEN SOFTENED, INDICATING THAT THE RESISTANCE HEATING (RH) COIL HAD HEATED AND THE DETACHMENT PROCESS HAD BEEN INITIATED. THE INTRODUCER SKIVE WAS SEEN DAMAGED PROXIMAL TO THE AREA WHERE THE DPU WAS PROTRUDING. THE V-NOTCH OF THE RESHEATHING TOOL WAS SEEN UNDAMAGED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT: (L12957) 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. INVESTIGATION CONCLUSION: THE COMPLAINT OF COIL PROTRUSION INTO PARENT VESSEL CANNOT BE CONFIRMED. THE PRODUCT ANALYSIS LAB CANNOT REPLICATE THE ENVIRONMENT IN WHICH A DEVICE IS DEPLOYED. FURTHERMORE, THREE DEVICES WERE RETURNED, AND NONE COULD BE IDENTIFIED. NO DEVICE WAS RETURNED WITH AN ATTACHED EMBOLIC COIL, AND NO EMBOLIC COILS WERE RETURNED SEPARATELY. ALL DEVICES HAD GONE THROUGH THE THERMAL DETACHMENT PROCESS INDICATED BY THE SOFTENING OF THEIR DISTAL OUTER SHEATHES. NO PIECES OF THE EMBOLIC COIL WERE SEEN ATTACHED TO THE DISTAL END OF THE DPU. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THE REPORTED COMPLAINT. THE INSTRUCTION FOR USE (IFU) GIVES INSTRUCTIONS FOR CORRECT DELIVERY OF THE DEVICE. COIL PROTRUSION INTO THE PARENT VESSEL AND THROMBOSIS ARE KNOWN POTENTIAL COMPLICATIONS OF COIL EMBOLIZATION PROCEDURES. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE COIL HERNIATION; HOWEVER, SINCE A STENT HAD BEEN USED, THE NECK WAS MOST LIKELY WIDE-NECK WHICH WOULD INCREASE THE LIKELIHOOD OF COIL PROTRUSION. IN ADDITION, THE EVENT OCCURRED WHEN THE CATHETER AND DELIVERY WIRE MOVED INTO THE ADJACENT ARTERY SEGMENT INDICATING THERE MAY HAVE BEEN CATHETER KICKBACK DURING REMOVAL OF THE WIRE. THROMBUS ASSOCIATED WITH DEVICES WITHIN THE ANEURYSM (COIL HERNIATION) IS A KNOWN COMPLICATION. SINCE THE EVENT RESULTED IN A SERIOUS INJURY THAT REQUIRED INTERVENTION, THE EVENT MEETS MDR REPORTING CRITERIA. WITHOUT THE COIL BEING RETURNED WITH THE DEVICE, EVALUATION AND ANALYSIS COULD NOT BE PERFORMED. IN ADDITION, THE REPORTED ISSUE THAT THE COIL PROTRUDED IN THE PARENT VESSEL IS AN INDICATION THAT THE COIL HAS ALREADY BEEN DEPLOYED AND DETACHED. THE PRODUCT ANALYSIS LAB IS NOT ABLE TO REPLICATE A TEST ENVIRONMENT TO TEST A DEVICE THAT HAS ALREADY BEEN DEPLOYED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). INITIAL REPORTER PHONE IS NOT AVAILABLE/REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. COIL PROTRUSION INTO THE PARENT VESSEL AND THROMBOSIS ARE KNOWN POTENTIAL COMPLICATIONS OF COIL EMBOLIZATION PROCEDURES. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE COIL HERNIATION; HOWEVER, SINCE A STENT HAD BEEN USED, THE NECK WAS MOST LIKELY WIDE-NECK WHICH WOULD INCREASE THE LIKELIHOOD OF COIL PROTRUSION. IN ADDITION, THE EVENT OCCURRED WHEN THE CATHETER AND DELIVERY WIRE MOVED INTO THE ADJACENT ARTERY SEGMENT INDICATING THERE MAY HAVE BEEN CATHETER KICKBACK DURING REMOVAL OF THE WIRE. THROMBUS ASSOCIATED WITH DEVICES WITHIN THE ANEURYSM (COIL HERNIATION) IS A KNOWN COMPLICATION. SINCE THE EVENT RESULTED IN A SERIOUS INJURY THAT REQUIRED INTERVENTION, THE EVENT MEETS MDR REPORTING CRITERIAL PENDING ADDITIONAL INFORMATION TO DETERMINE FACTORS RELATED TO ROOT CAUSE AND POSSIBLE TREATMENT OF THE EVENT. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L12957) 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. 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THAT TARGETED AN UNRUPTURED 5 MM ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH A 3.8MM NECK SIZE, AFTER THE 1.0MM X 2.5CM GALAXY G3 MINI COIL (GLM910025/L12957) WAS DELIVERED VIA THE PHENOM¿ .017 MICROCATHETER (MEDTRONIC) AND SUCCESSFULLY DETACHED AT THE TARGET LESION, THE MICROCATHETER AND THE DELIVERY WIRE HERNIATED FROM THE ANEURYSM AND THE A1 SEGMENT INTO THE M1 SEGMENT UPON THE REMOVAL OF THE DELIVERY WIRE. A LOOP OF THE COIL WAS PULLED BACK INTO THE PARENT ARTERY AND RESULTED IN A THROMBUS FORMATION. INTEGRILIN WAS ADMINISTERED AS AN INTERVENTION TO CLEAR THE CLOT AROUND THE COIL LOOP. IT WAS REPORTED THAT THERE WAS NO TREATMENT FOR THE COIL LOOP THAT WAS PULLED INTO THE PARENT ARTERY. THE VESSEL TORTUOSITY WAS REPORTED TO BE LOW. THE CONCOMITANT PRODUCTS THAT WERE USED IN THE PROCEDURE INCLUDED THE ATLAS¿ STENT (STRYKER), 5X10 HYDROFRAME® HYDROGEL FRAMING COIL (MICROVENTION), AND TWO SPECTRA COILS. THE STENT HAD BEEN IMPLANTED WHEN THE REPORTED EVENT OCCURRED, AND IT REMAINED WELL OPPOSED TO THE VESSEL WALL WITH GOOD NECK COVERAGE. THERE WAS NO EVIDENCE OF DISTAL THROMBUS EMBOLIZATION. THE DELIVERY WIRE WAS SUCCESSFULLY RETRIEVED INTO THE MICROCATHETER AND WAS REMOVED FROM THE PATIENT WITHOUT PATIENT INJURY OR ANY ADDITIONAL INTERVENTION. THE ANEURYSM WAS SUCCESSFULLY TREATED. THE PATIENT WAS REPORTED TO BE ¿FINE¿ AFTER THE PROCEDURE. THERE WAS A REPORT OF A 30-MINUTE DELAY IN THE PROCEDURE, BUT THIS WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989324 GALAXY G3 MINI 1MM X 2.5CM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD SEE H.10 L12957 10886704080220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R MEDTRONIC PHENOM¿.017 MICROCATHETER