BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAIA SECOND

    MDR report key: 12638016 · Received October 15, 2021

    Report

    Report Number
    3003775027-2021-00173
    Event Type
    Injury
    Date Received
    October 15, 2021
    Report Date
    October 15, 2021
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K171933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA. INVESTIGATION OF THE PAST GAIA SECOND COMPLAINTS RECEIVED AT ASAHI FOUND NO COMPLAINT OR ADVERSE EVENT REPORT THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. BASED ON THE OBTAINED INFORMATION FROM THE RESEARCH ARTICLE AS WELL AS THE KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT THE REPORTED VESSEL PERFORATION WAS ATTRIBUTED TO THE ANATOMICAL CONDITIONS AS WELL AS THE OPERATOR'S TECHNIQUE. NO ACTION IS TAKEN NOR IS PLANNED TO BE TAKEN AS THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. [MALFUNCTIONS AND ADVERSE EFFECTS] DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION. CARDIAC TAMPONADE DUE TO VESSEL PERFORATION..

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE TITLED "RETROGRADE ACCESS TO SEAL A LARGE CORONARY VESSEL BALLOON PERFORATION WITHOUT COVERED STENT IMPLANTATION (JOURNAL OF AMERICAN COLLEGE OF CARDIOLOGY (JACC) CASE REPORTS VOL.3, NO. 4, 2021; APRIL 2021: 542-5)" THAT AN ASAHI GAIA SECOND GUIDE WIRE MIGHT HAD CONTRIBUTED TO VESSEL PERFORATION. EXCERPT IS AS FOLLOWS: A (B)(6) WOMAN PRESENTED TO A PERIPHERAL HOSPITAL WITH ANGINA REFRACTORY TO MEDICAL TREATMENT. THE PATIENT HAD PREVIOUSLY ESTABLISHED CORONARY ARTERY DISEASE, WHICH CONSISTED OF PROXIMAL RIGHT CORONARY ARTERY (RCA) CHRONIC TOTAL OCCLUSION (CTO) IN CONJUNCTION WITH A SEVERE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) STENOSIS. SHE HAD REFUSED CORONARY BYPASS SURGERY. IN CONCORDANCE WITH PATIENT PREFERENCE AND HEART TEAM CONSENSUS, SHE WAS REFERRED FOR PERCUTANEOUS REVASCULARIZATION TO OUR HOSPITAL. THE PATIENT HAD WELL-CONTROLLED DIABETES MELLITUS AND HYPERTENSION. ALTHOUGH SHE HAD AN ANGIOGRAPHICALLY CONFIRMED CORONARY ARTERY DISEASE 6 MONTHS BEFORE, SHE HAD NO PRIOR HISTORY OF MYOCARDIAL INFARCTION. REVASCULARIZATION OF THE RCA CTO VIA THE ANTEGRADE APPROACH WAS CHOSEN AS THE FIRST STEP OF THE PROCEDURE BY THE HEART TEAM CONSENSUS. CORONARY ANGIOGRAPHY CONFIRMED THE KNOWN LESIONS: AN RCA CTO WITH RETROGRADE FILLING VIA SEPTAL COLLATERALS FROM THE LAD ALONG WITH A CRITICAL MID-LAD STENOSIS. A 6F JUDKINS RIGHT 4 GUIDING CATHETER WAS USED VIA THE RIGHT RADIAL APPROACH WITHOUT A CONTRALATERAL CATHETER IN THE LEFT SYSTEM. THE ANCHORING BALLOON TECHNIQUE WAS USED IN A PROXIMAL SIDE BRANCH TO STABILIZE THE CATHETER. AN ASAHI GAIA SECOND GUIDE WIRE WAS THEN CHOSEN AND WAS QUICKLY ADVANCED. NO RESISTANCE WAS FELT IN CROSSING AND A REPETITIVE COURSE OF THE GUIDEWIRE SEEMED TO TRACK THE ANGIOGRAPHIC COURSE OF THE RCA; TRUE-TO-TRUE CROSSING SUCCESS WAS ASSUMED. THE OCCLUSION WAS THEN PREDILATED WITH A BROSMED ARTIMES 1.25 X 10 MM BALLOON CATHETER, FOLLOWED BY A 2.5 X 30 MM BALLOON CATHETER. BOTH BALLOONS CROSSED WITHOUT ANY FEELING OF RESISTANCE. AFTER THE SECOND BALLOON INFLATION, THE PATIENT WAS IMMEDIATELY HEMODYNAMICALLY DESTABILIZED. CONTRAST INJECTION SHOWED EXTRAVASATION THROUGH THE HOLE CREATED BY THE BALLOON INFLATION INTO THE PERICARDIUM, CORRESPONDING TO AN ELLIS TYPE III PERFORATION AND TAMPONADE WITH TACHYCARDIA AND SEVERE HYPOTENSION RAPIDLY DEVELOPED. THE 2.5 X 30MM BALLOON WAS IMMEDIATELY INFLATED IN PROXIMAL RCA, FAR FROM THE PERFORATION SITE, TO PREVENT FURTHER BLOOD EXTRAVASATION. URGENT PERICARDIO CENTESIS WAS PERFORMED WITH PLACEMENT OF A PIGTAIL CATHETER INTO THE PERICARDIUM, AND REPEATED AUTOLOGOUS REINFUSION OF THE DRAINED PERICARDIAL BLOOD (400ML). SUBSEQUENTLY, THE PATIENT WAS HEMODYNAMICALLY STABILIZED. RETROGRADE ACCESS WAS URGENTLY OBTAINED THROUGH THE RIGHT FEMORAL ARTERY WITH PLACEMENT OF A 7-F EXTRA BACKUP 4 GUIDING CATHETER AT THE LEFT MAIN. CONTRAST INJECTION CONFIRMED THE PRESENCE OF THE GAIA SECOND WIRE INTO THE PERICARDIUM FAR FROM THE TRUE DISTAL RCA. AN ASAHI SION BLACK GUIDE WIRE SUCCESSFULLY CROSSED THE SEPTAL COLLATERALS, BUT ITS SUPPORTING ASAHI CORSAIR MICROCATHETER FAILED. THEREFORE, IT WAS REPLACED BY A FINECROSS MICROCATHETER, WHICH WAS SUCCESSFULLY ADVANCED TO THE DISTAL CAP. A GAIA SECOND WIRE SUCCESSFULLY PENETRATED THE DISTAL CAP, CROSSED THE OCCLUSION, AND REACHED THE PROXIMALLY INFLATED BALLOON. THE BALLOON WAS TRANSIENTLY DEFLATED, AND THE WIRE WAS ADVANCED TO THE ASCENDING AORTA; MEANWHILE, MORE BLOOD HAD TO BE DRAINED AND REINFUSED FROM THE PERICARDIUM TO THE PATIENT. THE SAME MANEUVER HAD TO BE PERFORMED UNTIL THE WIRE AND THE RETROGRADE MICROCATHETER WAS ADVANCED TO THE ANTEGRADE GUIDING CATHETER. FOLLOWING THAT, AN ASAHI RG3 GUIDE WIRE WAS EXTERNALIZED. THE OCCLUSION WAS PREDILATED WITH A SEMI-COMPLIANT BALLOON, AND A MEDTRONIC RESOLUTE 3.0 X 38 MM DRUG-ELUTING STENT (DES) WAS IMPLANTED OVER THE BALLOON-INDUCED HOLE, MINIMIZING CONTRAST EXTRAVASATION. A SECOND RESOLUTE 3.5 X 38 MM DES WAS IMPLANTED PROXIMALLY TO COVER THE ENTIRE LESION LENGTH. AFTER DILATION WITH 4.0 NONCOMPLIANT BALLOONS, COMPLETE SEALING OF THE PERFORATION WAS ACHIEVED WITHOUT COVERED STENT IMPLANTATION. THE LAD LESION WAS ALSO TREATED WITH A DES; THE FINAL ANGIOGRAPHIC RESULT WAS OPTIMAL. TOTAL PROCEDURE TIME WAS 90 MIN. THE PATIENT WAS THEN TRANSFERRED TO THE CORONARY CARE UNIT. PERICARDIAL DRAINAGE WAS PULLED THE NEXT DAY AFTER ECHOCARDIOGRAPHY REVEALED NO PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED 2 DAYS LATER IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539199 GAIA SECOND PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R