BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18773256 · Received February 23, 2024

    Report

    Report Number
    2210968-2024-01851
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    August 11, 2022
    Report Date
    February 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS (2022); 98 (XX): 1-5. HTTPS://DOI.ORG/10.1016/J.IJSCR.2022.107483.

    Description of Event or Problem · 0

    TITLE: REVERSAL OF PRIMARY OBESITY SURGERY ENDOLUMENAL FOLLOWING POSTOPERATIVE COMPLICATIONS: A CASE REPORT. A CASE REPORT OF A 45-YEAR-OLD WOMAN PRESENTED IN THE CLINIC WITH SEVERE EPIGASTRIC PAIN AND VOMITING. HER PAST SURGICAL HISTORY WAS SIGNIFICANT FOR A PRIMARY ENDOLUMENAL OBESITY SURGERY (POSE) ONE MONTH AGO. THE PATIENT¿S PAST MEDICAL HISTORY INCLUDED POLYCYSTIC OVARIAN SYNDROME, HYPERTENSION, AND RECURRENT MISCARRIAGES. SHE WAS ADMITTED FOR FURTHER EVALUATION AND MANAGEMENT. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION: (45 YEAR OLD FEMALE). -FEBRILE ON ADMISSION, AND LABORATORY INVESTIGATIONS SHOWED LEUKOCYTOSIS AND ELEVATED C-REACTIVE. PROTEIN (CRP). -SEVERE PAIN. TREATMENT: DICLOFENAC 1 SUPPOSITORY PER RECTAL TWICE DAILY, IBUPROFEN 400 MG IV Q8HRS FOR 3 DAYS, OXYCODONE 2 MG/H IV INFUSION + 2 MG IV BOLUS, ALONG WITH DORMICUM 2 MG AND KETAMINE 2 MG IV STAT FOR SEVERE PAIN. -GASTROGRAFIN SWALLOW REVEALED MARKED FREE AIR UNDER THE DIAPHRAGM, BUT WITH NO DEFINITE CONTRAST LEAK. HOWEVER, THERE WAS SUSPICION OF MUCOSAL THICKENING IN THE GASTRIC PYLORUS. TREATMENT: NOT MENTIONED. -AN ABDOMINAL CT SCAN WITH IV AND LIMITED ORAL CONTRAST REVEALED EVIDENCE OF A PREVIOUS SURGICAL PROCEDURE ALONG THE DISTAL BODY OF THE STOMACH, WITH THICKENING OF THE ANTRUM WALL, AND A MILDLY DISTENDED STOMACH LIKELY RELATED TO THE PATIENT¿S RECENT ENDOSCOPIC PROCEDURE. TREATMENT: NOT MENTIONED. -THE CT SCAN SHOWED LEAKAGE OF CONTRAST FROM THE GASTRIC FUNDUS, ALONG WITH A LARGE AMOUNT OF PNEUMOPERITONEUM AND FREE FLUID IN THE ABDOMEN. THESE FINDINGS WERE FOUND TO BE CONSISTENT WITH GASTRIC PERFORATION. TREATMENT: NOT MENTIONED. - THERE WERE ALSO MINIMAL, SMALL, LEFT-SIDED PLEURAL EFFUSIONS WITH ATELECTASIS OF THE BASAL SEGMENTS OF BOTH LOWER LOBES, WITH A SMALL RIGHT-SIDED PLEURAL AIR BUBBLE LIKELY REPRESENTING LEAKED AIR FROM THE ABDOMEN. TREATMENT: NOT MENTIONED. -YELLOWISH EXUDATIVE FLUID DRAINED FROM THE LEFT PLEURA. A NASOGASTRIC TUBE WAS ALSO INSERTED AND DRAINED 560 ML OF GASTRIC FLUIDS. TREATMENT: NOT MENTIONED. -FOR THE NEXT 6 DAYS, THE PATIENT WAS VITALLY STABLE AND AFEBRILE BUT STILL COMPLAINING OF MILD. ABDOMINAL PAIN AND LEFT CHEST PAIN. TREATMENT: NOT MENTIONED. -SEVEN DAYS LATER, THE PATIENT DEVELOPED SEVERE ABDOMINAL PAIN, VOMITING, TACHYCARDIA, AND ELEVATED TEMPERATURE. TREATMENT: NOT MENTIONED. -DIAGNOSTIC LAPAROSCOPY SHOWED A SEVERELY DILATED PROXIMAL STOMACH SECONDARY TO EXTREME NARROWING AT THE INCISURA ANGULARIS. THIS NARROWING WAS CAUSED BY FRAGMENTS OF PROLENE SUTURES IN THE GASTRIC BODY. TREATMENT: ALL SUTURES WERE PULLED OUT AND CUT WITH SCISSORS, WHICH RELIEVED THE OBSTRUCTION, AND THEREBY REVERSED THE POSE PROCEDURE. IN CONCLUSION, ENDOSCOPIC BARIATRIC THERAPIES (EBT) PRESENT A PROMISING ALTERNATIVE TO BARIATRIC SURGERY FOR OBESITY. WHILE THESE PROCEDURES ARE AN ATTRACTIVE, MINIMALLY INVASIVE, AND NON-SURGICAL WEIGHT LOSS OPTION GARNERING THE INTEREST OF MANY PATIENTS WHO HAVE FAILED TO ACHIEVE WEIGHT LOSS VIA CONSERVATIVE MEASURES, LITTLE HAS BEEN REPORTED ON THE MANAGEMENT OF POTENTIALLY FATAL COMPLICATIONS ASSOCIATED WITH THESE TECHNIQUES. TYPICALLY, PATIENTS UNDERGOING EBT FACE ONLY MINOR COMPLICATIONS (NAUSEA, VOMITING, AND ABDOMINAL PAIN), WHICH ARE MANAGED CONSERVATIVELY. BASED ON OUR EXPERIENCE WITH THIS PATIENT AND SIMILAR CASES IN LITERATURE, THEY ENCOURAGE FUTURE STUDIES TO FURTHER EXPLORE THE MANAGEMENT OF SUCH SEVERE COMPLICATIONS ASSOCIATED WITH POSE, PARTICULARLY INDICATIONS FOR REVERSAL, AND RECOMMEND THAT MORE ATTENTION BE PAID TO PROPER TRAINING AND SUPPORT FOR OPERATORS OF THE INCISIONLESS OPERATING PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126068 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention