BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7631746 · Received June 22, 2018

    Report

    Report Number
    2210968-2018-73714
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: OBES SURG. 2008; 18: 890¿892. DOI: 10.1007/S11695-007-9411-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: DELAYED RUPTURE OF A SPLENIC ARTERY PSEUDOANEURYSM AFTER BILIOPANCREATIC DIVERSION AUTHORS: PRASHANT K. UPADHYAYA, SOUJANYA CHAVA, SYED BIN-SANGHEER, RANJAN SUDAN, SUMEET K. MITTAL, SAMUEL CEMAJ. CITATION: OBES SURG. 2008; 18: 890¿892. DOI: 10.1007/S11695-007-9411-9. THIS CASE REPORT INVOLVED A (B)(6) MAN WAS ADMITTED FROM THE EMERGENCY ROOM AFTER PRESENTING WITH MASSIVE HEMETEMESIS AND SYNCOPE. HIS PAST HISTORY WAS SIGNIFICANT FOR AN OPEN BPD-DS 2 YEARS AGO. AN EMERGENCY GASTROESOPHAGOSCOPY WAS DONE. HOWEVER, THE SOURCE OF BLEEDING COULD NOT BE IDENTIFIED OWING TO LARGE AMOUNT OF CLOTS IN THE STOMACH AND JEJUNUM. A DECISION TO PERFORM AN EN BLOC SPLENECTOMY ALONG WITH REMOVAL OF THE PORTION OF ADHERENT STOMACH WAS MADE. THE BLEEDING TOTALLY CEASED ON DISSECTING AND CLAMPING THE PROXIMAL SPLENIC ARTERY AT THE LEVEL OF PANCREAS. ON VISUAL EXAMINATION OF THE SPECIMEN UPON OPENING UP OF THE STOMACH, WE IDENTIFIED A PROLENE STITCH USED IN THE REINFORCEMENT OF SLEEVE GASTRECTOMY TO BE ABUTTED AGAINST A SPLENIC ARTERY PSEUDOANEURYSM (SAP) AND ENTERING INTO THE STOMACH. THIS PSEUDOANEURYSM, 3 CM IN DIAMETER, WAS OPENING INTO THE STOMACH THROUGH THE SLEEVE GASTRECTOMY ANASTOMOSIS. TREATMENT INCLUDED LEAVING THE PROXIMAL AND DISTAL HALVES OF THE STOMACH UNCONNECTED AND PLACED A WOUND VACUUM-ASSISTED CLOSURE ON THE OPEN ABDOMEN AS PART OF DAMAGE CONTROL SURGERY. TWO DAYS LATER, THE PATIENT WAS TAKEN UP FOR SURGERY AND THE STOMACH CONTINUITY RESTORED BY END-TO-END ANASTOMOSIS AFTER EXTENSIVE ADHESIOLYSIS. THE PATIENT HAD A PROLONGED RECOVERY DUE OWING TO HIS CO-MORBIDITIES BUT MANAGED TO BE DISCHARGED IN A HEALTHY CONDITION. IT WAS REPORTED THAT THE CASE WAS UNIQUE IN THAT THE CAUSE OF SAP WAS IATROGENIC. THE ADVENTITIA OF THE DISTAL SPLENIC ARTERY WAS PROBABLY DAMAGED BY THE PROLENE STITCH TAKEN DURING PLACEMENT OF THE REINFORCING LAYER TO THE GASTRIC SLEEVE ANASTOMOSIS. ALTERNATIVELY, THE PROLENE SUTURE COULD GRADUALLY HAVE ERODED INTO THE SPLENIC ARTERIAL WALL TO FORM THE SAP. IT WAS CONCLUDED THAT THE POSSIBILITY OF SAP SHOULD BE KEPT IN MIND IN CASES OF GI BLEEDS IN PATIENTS HAVING UNDERGONE SURGERY IN THE PERIPANCREATIC AREA, ESPECIALLY WITH AN INCONCLUSIVE UPPER GI ENDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474410 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention