BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRD DEVICE, EMBOLIZATION, VASCULAR

    MDR report key: 19756310 · Received July 16, 2024

    Report

    Report Number
    1820334-2024-00961
    Event Type
    Injury
    Date Received
    July 16, 2024
    Report Date
    October 10, 2024
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. B3 - PATIENTS WERE TREATED BETWEEN JANUARY AND AUGUST 2017 D4 - RPN IS EITHER TORNADO® COILS, WHICH WERE 5 MM OR 10 MM IN DIAMETER AND 12.5 CM IN LENGTH (COOK) OR NESTER® EMBOLIZATION COILS, WHICH WERE BETWEEN 5 AND 18 MM IN DIAMETER AND 7 TO 14 CM IN LENGTH (COOK) E1 - CUSTOMER (PERSON) : DEPARTMENT OF GENERAL, TRANSPLANT AND LIVER SURGERY, MEDICAL UNIVERSITY OF WARSAW, 02-097 WARSAW, POLAND; THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT HAS BEEN CAPTURED IN A DIFFERENT REPORT. UPON FURTHER REVIEW OF THE ARTICLE, IT WAS DETERMINED THAT THE ONE PATIENT CAPTURED IN THIS REPORT WAS ALREADY CAPTURED IN REPORT #1820334-2024-00958 FOR "THE 5 PATIENTS WHO PRESENTED FOR SUBSEQUENT EXAMINATIONS". THIS PATIENT IS ONE OF THE FIVE PATIENTS. THEREFORE, THIS REPORT IS A DUPLICATE EVENT AND IS NOT REQUIRED.

    Description of Event or Problem · 0

    KOZIEL, S. ET AL. (2019) ENDOSCOPIC ULTRASOUND-GUIDED TREATMENT OF GASTRIC VARICES USING COILS AND CYANOACRYLATE GLUE INJECTIONS: RESULTS AFTER 1 YEAR OF EXPERIENCE. JOURNAL OF CLINICAL MEDICINE, 8, 1786. DOI:10.3390/JCM8111786 SUMMARY: GASTRIC VARICES (GVS) OCCUR IN 20% OF PATIENTS WITH PORTAL HYPERTENSION. GVS ARE ASSOCIATED WITH A 65% RISK OF BLEEDING OVER THE COURSE OF 2 YEARS AND HAVE A MORTALITY RATE OF UP TO 20%. THE STANDARD TREATMENT FOR GVS IS OBLITERATION WITH CYANOACRYLATE (CYA). THIS STUDY PRESENTS OUR EXPERIENCE WITH COMBINED THERAPY (VASCULAR COILS AND CYA) UNDER ENDOSCOPIC ULTRASOUND (EUS) GUIDANCE. METHODS: 16 PATIENTS (9 MALE AND 7 FEMALE) WERE INCLUDED INTO OUR STUDY, IN AGE RANGE 29¿75 YEARS. ETIOLOGY OF PORTAL HYPERTENSION INCLUDED: PORTAL VEIN THROMBOSIS (PVT) (31.0%), ISOLATED SPLENIC VEIN THROMBOSIS (SVT) (25.0%), ALCOHOLIC CIRRHOSIS (12.5%), HEPATITIS C CIRRHOSIS (19.0%), AND ALCOHOLIC CIRRHOSIS WITH PVT (12.5%). INDICATIONS FOR TREATMENT WERE BASED ON ENDOSCOPIC AND ENDOSONOGRAPHIC EVALUATIONS OF GVS. INCLUSION AND EXCLUSION CRITERIA WERE ALSO SPECIFIED. TECHNIQUE DEPENDED ON THE SIZE OF VARICES (DIFFERENT SIZE OF COILS + CYA ADDITIONALLY). THE RESULTS WERE BASED ON THE ACHIEVEMENT OF TECHNICAL SUCCESS, THERAPEUTIC EFFECTS, AND NUMBER OF ADVERSE EVENTS. AVERAGE FOLLOW-UP PERIOD WAS 327 DAYS. THE PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION WHILE THE PATIENT WAS ON THE BACK OR IN THE LEFT SIDE POSITION. BEFORE THE PROCEDURE, ALL PATIENTS RECEIVED ANTIBIOTIC PROPHYLAXIS (1 G OF THIRD- GENERATION CEPHALOSPORINS, INTRAVENOUSLY). A LINEAR ECHO-ENDOSCOPE FROM ANOTHER MANUFACTURER AND AN ULTRASOUND PLATFORM FROM ANOTHER MANUFACTURER WERE USED TO ADMINISTER TREATMENT. DURING THE FIRST STAGE OF THE PROCEDURE, VARICES WERE EVALUATED USING STANDARD ENDOSCOPY. AFTER THE EXAMINATION, THE STOMACH WAS FILLED WITH SALINE SOLUTION AND THE VARICES WERE ASSESSED WITH EUS. WE FOCUSED ON THE FOLLOWING: DETERMINING THE SIZE OF THE VARICES; EVALUATING THE FLOW RATES ON COLOR DOPPLER IDENTIFYING THE PERFORATING VESSELS SUPPLYING THE VARICEAL VEINS; AND DETERMINING THE OPTIMAL METHOD OF ACCESSING THE VARICES (TRANSESOPHAGEAL-TRANSCRURAL OR TRANSGASTRIC APPROACH). TO PUNCTURE THE VARICOSE VEINS AND IMPLANT THE COILS, STANDARD FINE-NEEDLE ASPIRATION WAS PERFORMED USING NEEDLES FROM ANOTHER MANUFACTURER. AFTER PUNCTURING THE VARICOSE VEINS, A NEEDLE STYLET WAS USED TO PUSH THE IMPLANTED 0.035-INCH EMBOLIC COILS. WE USED TWO TYPES OF COILS: TORNADO® COILS, WHICH WERE 5 MM OR 10 MM IN DIAMETER AND 12.5 CM IN LENGTH, AND NESTER® EMBOLIZATION COILS, WHICH WERE BETWEEN 5 AND 18 MM IN DIAMETER AND 7 TO 14 CM IN LENGTH (FIGURE 3). USING THE SAME NEEDLE, CYA GLUE FROM ANOTHER MANUFACTURER DILUTED IN LIPIODOL IN A 1:1 (0.5 ML + 0.5 ML) RATIO WAS INJECTED IN THE LUMEN OF THE VESSEL. AFTER THE PROCEDURE, HEMOSTASIS WAS CHECKED AND VASCULAR FLOW ON COLOR DOPPLER WAS EVALUATED. TECHNICAL SUCCESS WAS ACHIEVED WHEN COIL IMPLANTATION WAS COMPLETED, WHEREAS THERAPEUTIC SUCCESS WAS DEFINED BY THE LACK OF ACTIVE BLEEDING AND LIGATION OF VASCULAR FLOW IN THE OBLITERATED VARICOSE VEINS. DURING FOLLOW-UP, PATIENTS WERE ASSESSED ENDOSCOPICALLY AND ENDOSONOGRAPHICALLY AT 1, 3, AND 6 MONTHS, ALL 16 PATIENTS PRESENTED FOR THE FIRST CHECK-UP AS OUTPATIENTS. 13 PATIENTS (81.0%) UNDERWENT ADDITIONAL ELECTIVE PROCEDURES. THE AVERAGE FOLLOW-UP PERIOD WAS 327 DAYS (RANGE, 182¿443 DAYS). THERAPEUTIC SUCCESS WAS ACHIEVED IN ALL 12 PATIENTS TREATED WITH COIL IMPLANTATION AND CYA (75.0%). HOWEVER, FOR 4 PATIENTS IN WHOM CYA WAS NOT INJECTED, ACTIVE BLOOD FLOW IN THE TREATED VARICES WAS DIAGNOSED USING EUS DURING THE FIRST CHECK-UP. THIS REQUIRED REPEATED OBLITERATION USING COILS AND CYA. 1 PATIENT REQUIRED RE-IMPLANTATION OF 2 MORE COILS, 9 MONTHS AFTER THE FIRST PROCEDURE. 5 PATIENTS WHO PRESENTED FOR SUBSEQUENT EXAMINATIONS REQUIRED OBLITERATION OF RESIDUAL VARICES WITH CYA. 7 PATIENTS UNDERWENT ESOPHAGEAL VARICEAL LIGATION DUE TO ESOPHAGEAL VARICES. NO SERIOUS COMPLICATIONS WERE OBSERVED AFTER THE PROCEDURE. 3 PATIENTS (19.0%) HAD TRANSIENT ABDOMINAL PAIN AND 2 (12.5%) HAD FEVER PERSISTING UP TO 5 DAYS AFTER THE PROCEDURE. SYMPTOMS SUBSIDED AFTER ORAL ADMINISTRATION OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS. 1 PATIENT WAS HOSPITALIZED IN A PERIPHERAL CENTER DUE TO GASTROINTESTINAL BLEEDING SYMPTOMS (DARK STOOL, HEMOGLOBIN DECREASED BY 2 G %, NO HEMODYNAMIC DISTURBANCES). AFTER ENDOSCOPY WAS PERFORMED, ACTIVE BLEEDING SITE WAS NOT FOUND, AND THE PATIENT DID NOT REQUIRE ANY FURTHER ENDOSCOPIC TREATMENT. THE PROCEDURE DID NOT RESULT IN COMPLICATIONS SUCH AS EMBOLI OR DEATHS. DURING THE OBSERVATION PERIOD, THREE PATIENTS WITH LIVER CIRRHOSIS DROPPED OUT OF THE STUDY DUE TO ELECTIVE LIVER TRANSPLANTATION. RESULTS: FROM JANUARY TO AUGUST 2017, 16 PATIENTS WERE TREATED WITH EUS-GUIDED OBLITERATION OF GVS USING VASCULAR COILS ONLY OR COILS WITH CYA INJECTIONS. TECHNICAL SUCCESS WAS ACHIEVED IN 15 OUT OF 16 PATIENTS (94.0%). FOR 1 PATIENT WITH FUNDAL AND DUODENAL VARICES, THE DUODENAL VARIX RUPTURED DURING THE IMPLANTATION OF COILS, WHICH CAUSED MASSIVE BLEEDING. THE HEMORRHAGE WAS MANAGED WITH CYA INJECTIONS. THE NUMBER OF IMPLANTED COILS DURING ONE PROCEDURE RANGED FROM 1 TO 3 (AVERAGE, 1.7), AND THE VOLUME OF THE ADMINISTERED CYA (0.5 ML GLUE + 0.5 ML LIPIODOL) RANGED FROM 1 ML TO 9 ML (AVERAGE, 2 ML). BASED ON OUR RETROSPECTIVE RESEARCH WE HAVE CONCLUDED THAT EUS-GUIDED IMPLANTATION OF INTRAVASCULAR COILS COMBINED WITH CYA INJECTIONS IS AN EFFECTIVE METHOD OF TREATMENT WITH AN ACCEPTABLE NUMBER OF COMPLICATIONS. THIS REPORT CAPTURES ONE PATIENT WHO REQUIRED RE-IMPLANTATION OF 2 MORE COILS, 9 MONTHS AFTER THE FIRST PROCEDURE.

    Description of Event or Problem · 0

    THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749001 KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CYA GLUE - HISTOACRYL®| ECHOTIP® ULTRA 19G NEEDLES (COOK ENDOSCOPY)| LIPIODOL (LIPIODOL® ULTRAFLUID, GUERBET| THE LINEAR ECHO-ENDOSCOPE EG-3870-UTK (PENTAX®)| US PREIRUS PLATFORM (HITACHI MEDICAL SYSTEMS)