BEUDAMED
    FDA Adverse Event Death Summary report: N

    OBSIDIO

    MDR report key: 21696264 · Received March 26, 2025

    Report

    Report Number
    2124215-2025-17223
    Event Type
    Death
    Date Received
    March 26, 2025
    Date of Event
    February 9, 2024
    Report Date
    March 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    UDI-DI
    00191506039332
    PMA / PMN Number
    K213385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: THE PROCEDURE DATE WAS BETWEEN 9TH AND 12TH FEBRUARY 2024. JASON S. KIM, MD, R. PETER LOKKEN, MD, MPH, ALEXANDER LAM, MD, NESLIHAN KAYRAKLIOGLU, MD, PHD, K. PALLAV KOLLI, MD. "GASTRODUODENAL ARTERY EMBOLIZATION WITH SHEAR-THINNING CONFORMABLE EMBOLIC RESULTING IN PANCREATIC AND DUODENAL NECROSIS". JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 1- 17

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE, THAT MIGRATION OCCURRED RESULTING IN PATIENT COMPLICATIONS AND DEATH. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE OF THE POSTERIOR SUPERIOR PANCREATICODUODENAL ARTERY (PSPDA). THE PATIENT WAS ADMITTED FOR HYPOXEMIC RESPIRATORY FAILURE AND SWEETS SYNDROME, AND THE HOSPITAL COURSE WAS COMPLICATED BY MELENA. THE PATIENTS HEMOGLOBIN DECLINED OVERNIGHT FROM 7.1 TO 5.8 G/DL WITH RECURRENT MELENA AND HEMATEMESIS REQUIRING A BLOOD TRANSFUSION. A COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM DEMONSTRATED ACTIVE EXTRAVASATION INTO THE DUODENUM. ANGIOGRAPHY OF THE PSPDA WITH A 2.8 FRENCH NON-BOSTON SCIENTIFIC MICROCATHETER DEMONSTRATED A PSEUDOANEURYSM OF A SMALL BRANCH WHERE SUPER SELECTIVE CATHETERIZATION WAS IMPOSSIBLE. EMBOLIZATION OF THE PSPDA USING OBSIDIO WAS PERFORMED, WITH THE GOAL OF OCCLUDING BRANCHES BEYOND THE REACH OF THE MICROCATHETER. THE ALIQUOT TECHNIQUE WAS UTILIZED TO PRESERVE THE MICROCATHETER FOR LATER USE. WHILE APPLYING A SLOW INJECTION FORCE, 0.2 ML ALIQUOTS OF OBSIDIO WAS FLUSHED WITH A 3 ML SYRINGE AND IOHEXOL, WHICH WAS SURMISED TO BETTER RESEMBLE THE VISCOSITY OF OBSIDIO COMPARED TO NORMAL SALINE. THE EMBOLIC WAS ADMINISTERED UNTIL OPACIFICATION OF THE PSEUDOANEURYSM WAS ACHIEVED, DELIVERING A TOTAL OF 0.4 ML. FLUOROSCOPIC IMAGES DEMONSTRATED THE EMBOLIC DEPOSITED IN THE PSEUDOANEURYSM AND DISTAL BRANCHES MEASURING 0.2 TO 0.3 MM IN CALIBER, WHILE FORMING A CAST OF THE PARENT VESSEL. ANGIOGRAPHY OF THE GASTRODUODENAL ARTERY (GDA) DEMONSTRATED CONTINUED EXTRAVASATION FROM A SEPARATE BRANCH. OBSIDIO WAS THEREFORE ADMINISTERED WITH A MORE FORCEFUL INJECTION, WITH THE INTENTION OF ACHIEVING GDA OCCLUSION WITHOUT ADDITIONAL DISTAL EMBOLIZATION, USING 0.2 ML ALIQUOTS FOR A TOTAL OF 0.6 ML. ALTHOUGH DISTAL PENETRATION WITH SUBSEQUENT FLUSHING WAS NOT DIRECTLY OBSERVED, THE EMBOLIC PENETRATED INTO THE RIGHT GASTROEPIPLOIC ARTERY AND OTHER TERMINAL BRANCHES MEASURING 0.4 MM; NO REFLUX WAS APPRECIATED. THE PATIENTS POST PROCEDURE COURSE WAS COMPLICATED BY ABDOMINAL PAIN AND WHITE BLOOD CELL COUNT OF 52,000/MICROLITERS, LIPASE OF 240 U/L, AND LACTATE DEHYDROGENASE OF 601 U/L. A CT OF THE ABDOMEN/PELVIS OBTAINED ON POST PROCEDURE DAY 3, SHOWED REGIONAL NONENHANCEMENT OF THE DUODENUM AND PANCREATIC HEAD. THE PATIENT WAS EMERGENTLY TAKEN FOR EXPLORATORY LAPAROTOMY WHERE COMPLETE NECROSIS OF THE SECOND PORTION OF THE DUODENUM AND SEVERE PANCREATITIS OF THE PANCREATIC HEAD WERE OBSERVED. THE NECROTIC DUODENUM WAS RESECTED. THE PATIENT REMAINED IN CRITICAL CONDITION WITH THE POSTOPERATIVE COURSE COMPLICATED BY SEPSIS AND MULTI-ORGAN FAILURE. THE PATIENT WAS TRANSITIONED TO COMFORT CARE AND SUCCUMBED 18 DAYS AFTER EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805070 OBSIDIO VASCULAR EMBOLIZATION DEVICE KRD BOSTON SCIENTIFIC CORPORATION 00191506039332

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death| R MICROCATHETER: 2.8F PROGREAT TERUMO