KRD DEVICE, EMBOLIZATION, VASCULAR
Report
- Report Number
- 1820334-2024-00960
- Event Type
- Injury
- Date Received
- July 16, 2024
- Report Date
- November 20, 2024
- Manufacturer
- COOK INC
- Product Code
- KRD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3 - PATIENTS WERE TREATED BETWEEN (B)(6) AND (B)(6) 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, (B)(6); 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED AS PART OF A LITERATURE ARTICLE TITLED ¿ENDOSCOPIC ULTRASOUND-GUIDED TREATMENT OF GASTRIC VARICES USING COILS AND CYANOACRYLATE GLUE INJECTIONS: RESULTS AFTER 1 YEAR OF EXPERIENCE¿ THAT DURING COIL IMPLANTATION, ONE PATIENT EXPERIENCED A DUODENAL RUPTURE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. COOK ALSO REVIEWED PRODUCT LABELING: HE CURRENT INSTRUCTIONS FOR USE [T_CE_NEC_REV4] STATE THE FOLLOWING: ¿PRECAUTIONS PERFORM AN ANGIOGRAM PRIOR TO EMBOLIZATION TO DETERMINE CORRECT CATHETER POSITION. EVIDENCE GATHERED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, COOK COULD NOT ESTABLISH A DEFINITIVE CAUSE FOR THE REPORTED EVENT. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
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 WITH DUODENAL RUPTURE DURING COIL IMPLANTATION.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2504283 | 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) |