BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENOVOCATH

    MDR report key: 13935115 · Received March 29, 2022

    Report

    Report Number
    3011279674-2019-00003
    Event Type
    Death
    Date Received
    March 29, 2022
    Date of Event
    November 22, 2019
    Report Date
    March 28, 2022
    Manufacturer
    RENOVORX, INC.
    Product Code
    MJN
    PMA / PMN Number
    K191606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE PERFORMED AS INTENDED AND THEREFORE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION. A REVIEW OF LOT HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES OF COMPONENTS OR MANUFACTURING THAT COULD HAVE CONTRIBUTED TO THIS EVENT. A CLINICAL REVIEW OF THE EVENT INCLUDED REVIEW OF ANGIOGRAPHIC IMAGES OBTAINED FROM FLUOROSCOPY PERFORMED DURING THE INDEX PROCEDURE. THE PERIPROCEDURAL IMAGES SUGGEST THAT OVER INFLATION OF THE BALLOONS MAY HAVE CONTRIBUTED TO THE ARTERIAL INJURY RESULTING IN THE BLEED. THE RENOVOCATH DEVICE WAS DEPLOYED IN A RELATIVELY SMALLER DIAMETER VESSEL, APPROXIMATELY 3.5MM. THE PATIENT WAS KNOWN TO HAVE HAD A COMPLICATED MEDICAL HISTORY INCLUDING RESPIRATORY DISEASE (COPD) AS WELL AS AORTIC VALVE REPLACEMENT IN ADDITION TO PANCREATIC CANCER. THESE CONFOUNDING CONDITIONS MAY HAVE CONTRIBUTED TO HER DEATH. A LABELING REVIEW WAS PERFORMED AND THE FOLLOWING PRECAUTION IS NOTED, "TO REDUCE THE POTENTIAL FOR VESSEL DAMAGE, THE INFLATED DIAMETER OF THE BALLOON SHOULD APPROXIMATE THE DIAMETER OF THE VESSEL AT THE DESIRED SITE OF OCCLUSION." AN ADDITIONAL NOTE IN BOLD LETTERS INSTRUCTS THE OPERATOR, "NOTE: DETERMINE THE VESSEL SIZE IN THE TREATMENT SEGMENT USING STANDARD PRACTICES. REFER TO TABLE 1 FOR GUIDANCE ON THE AMOUNT OF INFLATION FLUID TO ACHIEVE A BALLOON DIAMETER." THE LABELING IS DETERMINED TO BE ADEQUATE, WITH SUFFICIENT INSTRUCTIONS, WARNINGS AND PRECAUTIONS. THE INVESTIGATOR HAS BEEN RETRAINED TO THE PROCEDURE (THIS WAS HIS SECOND TIME USING THE DEVICE). RENOVORX CONTINUES TO TRACK ALL ADVERSE EVENTS AND REPORTS OF DEVICE PERFORMANCE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED ON (B)(6) 2019. HOWEVER, THIS MDR IS BEING RESUBMITTED ON (B)(6) 2022 BECAUSE AN INVESTIGATION DETERMINED THAT THE ORIGINAL SUBMISSION WAS NOT PROPERLY ACCEPTED IN THE PRODUCTION WEBTRADER ENVIRONMENT.

    Description of Event or Problem · 0

    THE PATIENT HAD PANCREATIC HEAD ADENOCARCINOMA, WAS A PARTICIPANT IN THE RENOVORX DRUG TRIAL AND WAS RANDOMIZED TO THE TREATMENT ARM FOR THE DIRECT DELIVERY OF GEMCITABINE TO A PANCREATIC TUMOR. REPRESENTATIVES OF TRIAL SPONSOR WERE PRESENT DURING THE PROCEDURE. THIS WAS THE PATIENT'S SECOND ROUND OF TREATMENT IN THE STUDY (DATE OF TREATMENT (B)(6) 2019), TWO WEEKS FOLLOWING THE INITIAL ADMINISTRATION WHICH WAS SUCCESSFUL AND UNREMARKABLE. PROCEDURAL TIME WAS PROLONGED AS SEVERAL ATTEMPTS WERE MADE TO ACCESS GASTRODUODENAL ARTERY WITH AN 0.035" BENTON GUIDEWIRE AND POSITION OF THE RENOVOCATH DEVICE. TOTAL SEDATION TIME WAS RECORDED AS 160 MINUTES. FOLLOWING ACCESS, THE RENOVOCATH WAS ADVANCED TO THE DESIRED LOCATION AND THE BALLOONS WERE INFLATED TO ISOLATE THE VESSEL. CHEMOTHERAPY TREATMENT WAS ADMINISTERED FOR 20 MINUTES. THE RENOVOCATH WAS DEFLATED AND REMOVED. A SMALL AREA OF PSEUDOANEURYSM OF THE GASTRODUODENAL ARTERY WAS NOTED AFTER TREATMENT, HOWEVER THE INVESTIGATOR ELECTED TO LEAVE IT UNTREATED SO AS NOT TO PRECLUDE FUTURE CHEMOTHERAPY TREATMENT AT THE SITE. IN RECOVERY THE PATIENT BECAME HYPOTENSIVE AND BLOOD PRESSURE WAS RECORDED AT 56/37. THE PATIENT RECEIVED LEVOPHED AND NEO-SYNEPHRINE FOR BLOOD PRESSURE SUPPORT WITH MASSIVE TRANSFUSION PROTOCOL INITIATED (2 UNITES OF PRBSS AND 2 UNITS FFP). THE PATIENT RETURNED TO THE CL TO RULE OUT POSSIBLE BLEEDING AT THE TREATMENT SITE; FIRST THE GDA WAS INJECTED (THROUGH CELIAC ARTERY ACCESS) AN AREA OF PERFORATION WAS IDENTIFIED AND TREATED WITH COIL EMBOLIZATION; SUBSEQUENTLY THROUGH INJECTION OF SMA A SECOND AREA OF BLEED WAS IDENTIFIED AT INFERIORPANCREATIC- DOUDOUNAL ARTERY CONNECTION TO DISTAL GDA AND TREATED WITH COIL EMBOLIZATION TO TREAT THIS SECOND ARTERIAL BLEED SITE. THE PATIENT WAS TRANSFERRED TO ICU WEANED OFF OF PRESSOR AND REMAINED ONLY ON SUPPLEMENTAL OXYGEN, WITH STABILIZATION OF HER BLOOD COUNT (HEMATOCRIT). ON (B)(6) (SIX DAYS AFTER THE PROCEDURE) SHE WAS DIAGNOSED VIA CT SCAN WITH CONSOLIDATIVE PNEUMONIA. (B)(6) TRANSFERRED OUT OF ICU. (B)(6) POSSIBLE SEPSIS, NO CLEAR INFECTIOUS ETIOLOGY, TRANSFERRED BACK TO ICU. (B)(6) ASCITES, HEMOPERITONEUM, TREATED WITH ANTIBIOTICS. EXAMINATION (B)(6) FOLLOWING CHEST X-RAY DETERMINED THE PATIENT TO BE IN ACUTE HYPOXEMIC RESPIRATORY FAILURE. (B)(6) WORSENING OF RENAL FUNCTION. MEDICAL MANAGEMENT WAS INITIATED. PATIENT REMAINED HEMODYNAMICALLY STABLE UNTIL (B)(6) AT WHICH TIME THE PATIENT BECAME MORE ACUTELY HYPOXIC AND HYPOTHERMIC WITH ALTERED MENTAL STATUS AND SEVERE METABOLIC AND RESPIRATORY ACIDOSIS WITH PH<6.9. SHE WAS INTUBATED AND STARTED ON VASOPRESSOR SUPPORT FOR HYPOTENSION. AFTER CONSULTING WITH FAMILY, THE PATIENT WAS WEANED FROM VASOPRESSORS AND VENTILATORY SUPPORT AND TRANSFERRED TO COMFORT CARE. SHE EXPIRED SOON AFTER ON (B)(6) 2019. THE CAUSE OF DEATH RECORDED IS METASTATIC PANCREATIC CANCER, INTRAABDOMINAL HEMORRHAGE, MULTIFACTORIAL SHOCK, CARDIOPULMONARY FAILURE. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588300 RENOVOCATH VASCULAR CLAMP, PRODUCT CODE: MJN MJN RENOVORX, INC. MMRC120-DB-1111 Z2458105D

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death FFP AND PRBS X 2 UNITS EACH| GEMCITIBINELEVOPRESSORNEO-SYNEPHRINEFFP (X2)PR| LOPRESSOR| NEO-SYNEPHRINE