BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE

    MDR report key: 3677556 · Received March 13, 2014

    Report

    Report Number
    3005099803-2014-01445
    Event Type
    Injury
    Date Received
    March 13, 2014
    Report Date
    February 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGES ARE UNKNOWN; HOWEVER, THE PATIENT AGES WERE REPORTED TO RANGE FROM 48 TO 85 YEARS OLD. REPORTEDLY, THERE WERE 23 MALES AND 27 FEMALES IN THE STUDY. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE UPN AND LOT NUMBERS. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. LITERATURE SOURCE: ¿SINGLE-STAGE INTRAOPERATIVE TRANSHEPATIC BILIARY STENTING IN PATIENTS WITH UNRESECTABLE HEPATOBILIARY PANCREATIC TUMORS¿, SURGICAL ENDOSCOPY, JULY 18, 2013. (B)(4) FOR THE REPORTED EVENT OF STENT BLOCKED/OCCLUDED. (B)(4) FOR THE REPORTED EVENT OF EARLY STENT NON-FUNCTION. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE ¿SINGLE-STAGE INTRAOPERATIVE TRANSHEPATIC BILIARY STENTING IN PATIENTS WITH UNRESECTABLE HEPATOBILIARY PANCREATIC TUMORS¿ WRITTEN BY Y. IWASAKI, ET AL. IT IS IMPORTANT TO MENTION THAT BSC WALLSTENT BILIARY STENTS AND COMPETITOR STENTS WERE INCLUDED WITHIN THE ARTICLE. NO SPECIFIC PATIENT INFORMATION, DEVICE INFORMATION OR SPECIFIC EVENT INFORMATION IS AVAILABLE PER THE AUTHOR. THIS REPORT PERTAINS TO 31 EVENTS (23 OCCLUSIONS, 2 EARLY STENT NON-FUNCTIONS, 2 GASTROINTESTINAL HEMORRHAGES, 1 LYMPHORRHEA, 2 CHOLANGITIS AND 1 ENTEROCUTANEOUS FISTULA). THE 3 EVENTS OF DEATH ARE REPORTED SEPARATELY UNDER MDR ID 3005099803-2014-01446. FIFTY PATIENTS ((B)(6) MALES AND (B)(6) FEMALES; AND AGES RANGED FROM (B)(6) YEARS OLD) WERE ANALYZED. ACCORDING TO THE ARTICLE, THE INDICATION FOR STENT PLACEMENT IN EACH OF THE 50 CASES WAS FOR TREATMENT OF UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION DIAGNOSED INTRAOPERATIVELY. THE STENTS WERE IMPLANTED DURING INTRAOPERATIVE TRANSHEPATIC BILIARY STENTING PROCEDURES BETWEEN APRIL 2001 AND MAY 2009. REPORTEDLY, THE PREOPERATIVE CLINICAL BACKGROUNDS OF THE PATIENTS INCLUDED 22 INSTANCES OF PANCREATIC CANCER, 21 PATIENTS WITH BILIARY CANCER, 6 INSTANCES OF LIVER CANCER AND 1 PATIENT WITH DUODENAL CANCER. PREOPERATIVE BILIARY DECOMPRESSION WAS PERFORMED FOR 45 PATIENTS. FOR 26 PATIENTS, WHO UNDERWENT PREOPERATIVE PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD), THE STENT WAS PLACED BY THE PTBD ROUTE IN A SINGLE STAGE. FOR 24 PATIENTS, THE INTRAHEPATIC BILE DUCTS WERE INTENTIONALLY DILATED BY INJECTION OF SALINE VIA ENDOSCOPIC NASOBILIARY DRAINAGE OR PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE, AND THE PUNCTURE WAS PERFORMED UNDER INTRAOPERATIVE ULTRASOUND GUIDANCE FOLLOWED BY GUIDEWIRE AND CATHETER INSERTION. THE STENT WAS PLACED IN THE SAME MANNER. OF THE 50 PATIENTS, 22 ONLY HAD STENT IMPLANTATION DURING THE PROCEDURE, WHEREAS 28 ALSO UNDERWENT COMBINED PROCEDURES; 11 GASTROJEJUNOTSOMY, 10 CHOLECTYSTECTOMY, 3 GASTROJEJUNOSTOMY AND CHOLECYSTECTOMY, AND 4 UNKNOWNS. THE ARTICLE REPORTED 23 CASES OF STENT OCCLUSION, 8 OF WHICH WERE ¿EARLY OCCLUSIONS¿, 2 EARLY STENT NON-FUNCTIONS (UNKNOWN), AND 6 COMPLICATIONS (THE SUBJECTS OF THIS REPORT MDR ID 3005099803-2014-01445). OF THE 6 COMPLICATIONS; 2 WERE GASTROINTENSTINAL HEMORRHAGES, 2 WERE CHOLANGITIS, 1 LYMPHORRHEA AND 1 ENTEROCUTANEOUS FISTULA. OF THE 23 PATIENTS WITH STENT OCCLUSIONS, 12 UNDERWENT PTBD, 3 UNDERWENT ENDOSCOPIC DECOMPRESSION WITH A PLASTIC STENT AND 8 REFUSED TREATMENT. THERE WERE ALSO 3 DEATHS (THE SUBJECT OF MDR ID 3005099803-2014-01446); 1 DUE TO GASTROINTENSTINAL HEMORRHAGE 82 DAYS POST-OP, 1 DUE TO PLEURAL EFFUSION 25 DAYS POST-OP AND 1 DUE TO WOUND DEHISCENCE AT 44 DAYS POST-OP. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THESE EVENTS TO DATE. THERE WERE MULTIPLE PATIENT COMPLICATIONS AND PRODUCT MANUFACTURERS REPORTED IN THIS STUDY, WITH THE LIMITED INFORMATION AVAILABLE, BSC UNABLE TO CONCLUDE SPECIFIC PATIENT INFORMATION AND DEVICE INVOLVEMENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149873 WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK384

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention