BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASTATO XS 20

    MDR report key: 18619786 · Received January 31, 2024

    Report

    Report Number
    3003775027-2024-00009
    Event Type
    Death
    Date Received
    January 31, 2024
    Report Date
    February 1, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K163426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. MULTIPLE ASAHI PRODUCTS WERE USED IN THIS STUDY; HOWEVER, HOW EACH MENTIONED PRODUCT HAD CAUSED OR CONTRIBUTED TO MACE WAS UNABLE TO BE DETERMINED BASED ON THE LIMITED WRITTEN INFORMATION. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENT ANATOMY AND PROCEDURAL CONTENTS WERE MOST LIKELY ASSOCIATED WITH ADVERSE EVENTS OCCURRED DURING THIS STUDY. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. 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. ~ NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. ~ IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. ~ USE THIS GUIDE WIRE CAREFULLY AS THE GUIDE WIRE MAY PENETRATE THE BLOOD VESSEL. OTHERWISE, IT MAY CAUSE ADVERSE EVENTS SUCH AS BLOOD VESSEL PERFORATION AND CORONARY ARTERY DISSECTION. THE HIGHER TORQUE PERFORMANCE, STIFFER DISTAL END, AND/OR HIGHER ADVANCEMENT FORCE MAY PRESENT A HIGHER RISK OF PERFORATION OR INJURY THAN IF USING A MORE FLEXIBLE GUIDE WIRE. THEREFORE, USE THE MOST FLEXIBLE GUIDE WIRE THAT WILL TREAT THE LESION (I.E., THE GUIDE WIRE WITH THE SMALLEST TIP LOAD THAT WILL TREAT THE LESION), AND TAKE DUE CARE TO MINIMIZE THE RISK OF PERFORATION OR OTHER DAMAGE TO BLOOD VESSELS. [MALFUNCTION AND ADVERSE EFFECTS] ~ TRAUMA, ~ DAMAGE TO A VESSEL, INCLUDING POSSIBLE VESSEL PERFORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITERATURE THAT ASAHI PRODUCTS - SION BLACK GUIDE WIRE, SUOH 03 GUIDE WIRE, CORSAIR MICROCATHETER, CORSAIR PRO MICROCATHETER, CARAVEL MICROCATHETER, ASTATO XS 20 GUIDE WIRE, AND SION GUIDE WIRE - MIGHT HAVE CAUSED OR CONTRIBUTED TO MACE. PUBLICATION: JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 16, NO. 22, 2023. NOVEMBER 27, 2023:2748-2762. TITLE: THE RETROGRADE APPROACH TO CHRONIC TOTAL OCCLUSION PERCUTANEOUS CORONARY INTERVENTIONS: TECHNICAL ANALYSIS AND PROCEDURAL OUTCOMES. EXCERPTS: [METHODS] THIS STUDY IS A RETROSPECTIVE STUDY USING THE PROGREDD-CTO REGISTRY ON RETROGRADE CTO PCIS PERFORMED BY EXPERIENCED 44 CENTERS BETWEEN 2012 AND MARCH 2023. THE BASELINE CLINICAL AND ANGIOGRAPHIC CHARACTERISTICS AND PROCEDURAL OUTCOMES (TECHNICAL SUCCESS, PROCEDURAL SUCCESS, AND IN-HOSPITAL MACE) WERE ANALYZED BY USE OF STATISTICAL METHODS. [RESULTS] OF THE 11,808 CTO PCIS RECORDED IN THE REGISTRY DURING THE STUDY PERIOD, RETROGRADE CROSSING WAS ATTEMPTED IN 4,058 (34.3%). MEAN AGE WAS 64.6?}10.4 YEARS, 84.0% OF THE PATIENTS WERE MEN, AND MEAN LEFT VENTRICULAR EJECTION FRACTION WAS 50.0%?}12.7%. THE RETROGRADE APPROACH WAS THE PRIMARY CROSSING STRATEGY IN 40.4% OF THE LESIONS. THE RETROGRADE APPROACH WAS SUCCESSFUL IN 60.5% OF THE ATTEMPTED CASES. ANTEGRADE DISSECTION RE-ENTRY (ADR) WAS THE SECOND MOST SUCCESSFUL STRATEGY (11.5%), FOLLOWED BY ANTEGRADE WIRING (9.6%). CTO CROSSING FAILED IN 18.4% OF THE CASES. THE MOST COMMON REASON FOR FAILURE OF THE RETROGRADE APPROACH WAS FAILURE OF COLLATERAL CROSSING WITH A GUIDEWIRE (64.2%), FOLLOWED BY FAILED RE-ENTRY INTO THE TRUE LUMEN (19.7%) AND FAILED COLLATERAL MICROCATHETER CROSSING (9.7%). THE OVERALL TECHNICAL AND PROCEDURAL SUCCESS WERE 78.7% AND 76.6%, RESPECTIVELY. WHEN RETROGRADE CROSSING FAILED, TECHNICAL SUCCESS WAS ACHIEVED IN 50.3% OF CASES USING THE ANTEGRADE APPROACH. THE INCIDENCE OF IN-HOSPITAL MACE, CLINICAL CORONARY PERFORATION (DEFINED AS ACTIONABLE PERFORATIONS THAT REQUIRED ANY INTERVENTION), AND ANY CORONARY PERFORATION WERE 3.5%, 5.8%, AND 9.5%, RESPECTIVELY. THE INCIDENCE OF PERICARDIOCENTESIS WAS 1.3%. THERE WAS NO SIGNIFICANT DIFFERENCE IN IN-HOSPITAL MACE BASED ON SUCCESSFUL CROSSING STRATEGY (2.3% FOR ANTEGRADE WIRING, 3.5% FOR ADR, AND 3.4% FOR RETROGRADE; P = 0.38). WHEN CTO CROSSING FAILED, THE RATES OF ANY CORONARY PERFORATION, CLINICAL CORONARY PERFORATION, SUBSEQUENT PERICARDIOCENTESIS, AND EMERGENCY CABG WERE 14.1%, 7.9%, 2.1%, AND 0.5%, RESPECTIVELY. THE SION, SION BLACK, AND SUOH 03 (ASAHI INTECC) WERE THE MOST USED WIRES AND THE CORSAIR/CORSAIR PRO (ASAHI INTECC), TURNPIKE LP (TELEFLEX), AND CARAVEL (ASAHI INTECC) WERE THE MOST USED MICROCATHETERS FOR SUCCESSFUL RETROGRADE COLLATERAL CROSSING. CLINICAL CORONARY PERFORATION OCCURRED IN 5.8% OF THE CASES; HOWEVER, ONLY 1.4% OF THE PATIENTS REQUIRED PERICARDIOCENTESIS OR EMERGENCY CABG. [CONCLUSIONS] RETROGRADE CTO PCI IS UTILIZED IN PATIENTS WITH HIGH LESION COMPLEXITY AND IS ASSOCIATED WITH MODERATE-TO HIGH SUCCESS RATES IN THE HANDS OF EXPERIENCED OPERATORS. RETROGRADE CTO PCI CARRIES INCREASED RISK OF COMPLICATIONS; HOWEVER, MOST CORONARY PERFORATIONS CAN BE MANAGED CONSERVATIVELY OR PERCUTANEOUSLY. USE OF SEPTAL COLLATERALS AND TRUE LUMEN CROSSING, WHEN FEASIBLE, WERE THE SAFEST STRATEGIES IN RETROGRADE CTO PCI. CONVENTIONAL REVERSE CART AND EXTENDED REVERSE CART WERE ASSOCIATED WITH THE HIGHEST, AND CONTEMPORARY REVERSE CART WITH THE LOWEST, RATES OF CLINICAL CORONARY PERFORATION. CONSIDERING INCREASING UTILIZATION OF GUIDE EXTENSION-ASSISTED REVERSE CART OVER TIME AND ITS ASSOCIATION WITH A RELATIVELY LOW IN-HOSPITAL MACE, IT APPEARS TO HAVE A GOOD BALANCE OF FEASIBILITY AND SAFETY AMONG RETROGRADE DISSECTION REENTRY TECHNIQUES. [FIGURE 2] SUCCESSFUL RETROGRADE CROSSING STRATEGIES: RETROGRADE TRUE LUMEN CROSSING WAS ACHIEVED IN 31.8%, FOLLOWED BY CONVENTIONAL REVERSE CART (34.4%), GUIDE EXTENSION-ASSISTED REVERSE CART (19.4%), ANTEGRADE CROSSING USING THE RETROGRADE WIRE AS MARKER (5.4%), AND CONTEMPORARY REVERSE CART (4.4%). EXTENDED REVERSE CART AND CART WERE USED IN 2.0% AND 2.1%, RESPECTIVELY. ELECTROCAUTERY REVERSE CART WAS USED IN ONLY 5 CASES (0.2%) OF WIRE-IMPENETRABLE PROXIMAL OR DISTAL CAP DESPITE THE USE OF STIFF-TIP GUIDEWIRES (ASTATO 20 [ASAHI INTECC] WAS USED IN 4 OF 5 CASES). [TABLE 3] PROCEDURAL OUTCOMES OF THE STUDY LESIONS: ALL RETROGRADE CASES (N=4,058). IN-HOSPITAL MACE 141 (3.5%), DEATH 32 (0.8%), ACUTE MYOCARDIAL INFARCTION 45 (1.1%), STROKE 9 (0.2%), ANY CORONARY PERFORATION 385 (9.5%), CLINICAL CORONARY PERFORATION 235 (5.8%), TAMPONADE 75 (1.8%), DONOR VESSEL INJURY 49 (1.2%), VASCULAR ACCESS SITE COMPLICATIONS 54 (1.3%). RETROGRADE CROSSING SUCCESSFUL (N=2,454). IN-HOSPITAL MACE 84 (3.4%), DEATH 21 (0.9%), ACUTE MYOCARDIAL INFARCTION 31 (1.3%), STROKE 7 (0.3%), ANY CORONARY PERFORATION 202 (8.2%), CLINICAL CORONARY PERFORATION 126 (5.1%), TAMPONADE 38 (2.1%), DONOR VESSEL INJURY 35 (1.4%), VASCULAR ACCESS SITE COMPLICATIONS 34 (1.4%). RETROGRADE CROSSING FAILURE/ANTEGRADE CROSSING SUCCESS (N=831). IN-HOSPITAL MACE 25 (2.9%), DEATH 5 (0.6%), ACUTE MYOCARDIAL INFARCTION 7 (0.8%), STROKE 0 (0%), ANY CORONARY PERFORATION 77 (9.0%), CLINICAL CORONARY PERFORATION 50 (5.8%), TAMPONADE 18 (1.6%), DONOR VESSEL INJURY 6 (0.8%), VASCULAR ACCESS SITE COMPLICATIONS 8 (1.1%). OVERALL LESION CROSSING FAILURE (N=748). IN-HOSPITAL MACE 32 (4.3%), DEATH 6 (0.8%), ACUTE MYOCARDIAL INFARCTION 7 (0.9%), STROKE 2 (0.3%), ANY CORONARY PERFORATION 106 (14.1%), CLINICAL CORONARY PERFORATION 59 (7.9%), TAMPONADE 19 (2.5%), DONOR VESSEL INJURY 6 (0.8%), VASCULAR ACCESS SITE COMPLICATIONS 8 (1.1%). P VALUE IN-HOSPITAL MACE 0.30, DEATH 0.68, ACUTE MYOCARDIAL INFARCTION 0.50, STROKE 0.31, ANY CORONARY PERFORATION <0.001, CLINICAL CORONARY PERFORATION 0.02, TAMPONADE 0.23, DONOR VESSEL INJURY 0.28, VASCULAR ACCESS SITE COMPLICATIONS 0.78. [TABLE 4] TECHNICAL CHARACTERISTICS OF COLLATERAL CHANNEL CROSSING ATTEMPTS AND THE WIRES AND MICROCATHETERS USED WIRES: FIRST COLLATERAL CROSSING ATTEMPT - SION: 30.8%, SION BLACK: 15.8%, SUOH 03: 11.7%. SECOND COLLATERAL CROSSING ATTEMPT - SION: 27.2%, SION BLACK: 24.2%, SUOH 03: 23.3%. THIRD COLLATERAL CROSSING ATTEMPT - SION BLACK: 31.0%, SION: 24.6%, SUOH 03: 14.1%. MICROCATHETERS: FIRST COLLATERAL CROSSING ATTEMPT - CORSAIR/CORSAIR PRO: 34.6%, TURNPIKE LP: 24.1%, CARAVEL: 13.5%. SECOND COLLATERAL CROSSING ATTEMPT - TURNPIKE LP: 28.9%, CORSAIR/CORSAIR PRO: 22.6%, CARAVEL: 22.7%. THIRD COLLATERAL CROSSING ATTEMPT - CORSAIR/CORSAIR PRO: 33.1%, CARAVEL: 29.8%, TURNPIKE LP: 18.2%. SION BLACK: MFR REPORT #3003775027-2024-00004. SUOH 03: MFR REPORT #3003775027-2024-00005. CORSAIR: MFR REPORT #3003775027-2024-00006. CORSAIR PRO: MFR REPORT #3003775027-2024-00007. CARAVEL: MFR REPORT #3003775027-2024-00008. SION: MFR REPORT #3003775027-2024-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261240 ASTATO XS 20 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H| D| O| R