BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE*75MM LINEAR CUTTER

    MDR report key: 9941100 · Received April 8, 2020

    Report

    Report Number
    3005075853-2020-02072
    Event Type
    Death
    Date Received
    April 8, 2020
    Report Date
    March 30, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013211
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: RANDOMIZED TRIAL COMPARING SIDE-TO-SIDE STAPLED AND HAND-SEWN ESOPHAGOGASTRIC ANASTOMOSIS IN NECK AUTHORS: SUNDEEP SINGH SALUJA, SUKANTA RAY, SUJOY PAL, SUMIT SANYAL, NIKHIL AGRAWAL, NIHAR RANJAN DASH, PEUSH SAHNI, TUSHAR KANTI CHATTOPADHYAY. CITATION: J GASTROINTEST SURG. 2012; 16: 1287¿1295. DOI: 10.1007/S11605-012-1885-7. LEAK FROM CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS (CEGA) FOLLOWING ESOPHAGECTOMY IS ASSOCIATED WITH MORBIDITY AND POOR FUNCTIONAL OUTCOME. TO ADDRESS THIS ISSUE, THE AUTHORS CONDUCTED A RANDOMIZED TRIAL COMPARING ¿HAND-SEWN¿ WITH ¿STAPLED SIDE-TO-SIDE¿ CEGA. OF 174 PATIENTS WHO UNDERWENT ESOPHAGEAL RESECTION AND CEGA BETWEEN 2004 AND 2010, 87 PATIENTS (AGE: 51.4 ± 12 YEARS; 61 MALE AND 26 FEMALE PATIENTS) WERE RANDOMIZED TO ¿HAND-SEWN¿ CEGA AND 87 PATIENTS (AGE: 50.9 ± 14 YEARS; 54 MALE AND 33 FEMALE PATIENTS) WERE RANDOMIZED TO ¿STAPLED SIDE-TO-SIDE¿ CEGA. IN ALL PATIENTS, FINGER DILATATION OF PYLORUS WAS DONE WHEN REQUIRED. THE GASTRIC CONDUIT WAS CONSTRUCTED WITH MULTIPLE FIRINGS OF A TLC 75-MM LINEAR CUTTER (ETHICON) ALONG THE LESSER CURVATURE. IN THE SIDE-TO-SIDE STAPLED TECHNIQUE, TWO STAY SUTURES WERE THEN TAKEN, ONE AT THE ANTERIOR CORNER OF THE ESOPHAGUS AND ANOTHER BETWEEN THE POSTERIOR CORNER OF ESOPHAGUS AND THE MIDDLE OF THE GASTROTOMY. THESE STAY SUTURES WERE RETRACTED DOWNWARDS AS THE ENDOPATH EZ 45 ENDOSCOPIC LINEAR CUTTER (ETHICON) WAS INTRODUCED, THE THINNER PORTION INTO THE STOMACH AND THE THICKER STAPLE-BEARING PORTION INTO THE ESOPHAGUS. THE STAPLE CARTRIDGE WAS THEN ROTATED CLOCKWISE SO THAT THE POSTERIOR WALL OF THE ESOPHAGUS AND THE ANTERIOR WALL OF THE STOMACH WERE ALIGNED IN A PARALLEL MANNER, KEEPING THE SITE OF THE ANASTOMOSIS WELL AWAY FROM THE GASTRIC STAPLE SUTURE LINE. A LONG SIDE-TO-SIDE ANASTOMOSIS WAS THEN MADE BY FIRING THE STAPLER. THE STAPLER WAS THEN REMOVED, AND THE ANASTOMOSIS WAS INSPECTED FOR BLEEDING. A 16 F NASOGASTRIC TUBE WAS PLACED ACROSS THE ANASTOMOSIS. IN THE HAND-SEWN TECHNIQUE, REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE (N-14), POSTOPERATIVE COMPLICATIONS (N-36), BENIGN ANASTOMOTIC STRICTURE (N-17) WHICH REQUIRED ENDOSCOPIC DILATATION (ONE SITTING), FOLLOWED BY DAILY HOME-BASED SELF-DILATATION WITH A FOLEY'S CATHETER, MINOR LEAK (N-7) WHICH WERE MANAGED CONSERVATIVELY, AND MAJOR LEAK (N-6) WHICH WERE MANAGED CONSERVATIVELY WITH NECK WOUND DRAINAGE, ANTIBIOTICS, FEEDING JEJUNOSTOMY, GRADUAL RESUMPTION OF ORAL FEEDING. IN THE SIDE-TO-SIDE STAPLED TECHNIQUES, REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE (N-16), POSTOPERATIVE COMPLICATIONS (N-35), BENIGN ANASTOMOTIC STRICTURE (N-7) WHICH REQUIRED ENDOSCOPIC DILATATION (ONE SITTING), FOLLOWED BY DAILY HOME-BASED SELF-DILATATION WITH A FOLEY'S CATHETER, MINOR LEAK (N-6) WHICH WERE MANAGED CONSERVATIVELY, AND MAJOR LEAK (N-7) WHICH WERE MANAGED CONSERVATIVELY WITH NECK WOUND DRAINAGE, ANTIBIOTICS, FEEDING JEJUNOSTOMY, GRADUAL RESUMPTION OF ORAL FEEDING. OTHER REPORTED COMPLICATIONS INCLUDED SEPTICEMIA LEADING TO DEATH (N-1), GASTRIC CONDUIT STAPLED LINE LEAK LEADING TO DEATH (N-1), AND MEDIASTINITIS LEADING TO DEATH (N-1). IN CONCLUSION, THE ANASTOMOTIC LEAK RATES AS WELL AS POSTOPERATIVE OUTCOMES WERE COMPARABLE AMONG PATIENTS UNDERGOING ESOPHAGECTOMY WITH STAPLED OR HAND-SEWN CEGA. THIS SUGGESTS THAT FACTORS OTHER THAN THOSE RELATED TO THE ANASTOMOTIC TECHNIQUE MAY PLAY A MAJOR ROLE IN THE OCCURRENCE OF ANASTOMOTIC LEAKS. FURTHER, ANASTOMOTIC STRICTURES OCCUR LESS OFTEN FOLLOWING A STAPLED SIDE¿SIDE CEGA TECHNIQUE. THOUGH THE STAPLED TECHNIQUE IS FASTER, IT DOES NOT DECREASE THE OVERALL OPERATING TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397664 PROXIMATE*75MM LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. TLC75 10705036013211

    Patients

    Seq Age Sex Outcome Treatment
    1 Death