BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 5112339 · Received September 29, 2015

    Report

    Report Number
    1219930-2015-00847
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 1, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBERS ASSOCIATED: THIS REPORT: MFR REPORT #: 1219930-2015-00847, (B)(4). MFR REPORT #: 1219930-2015-00846, (B)(4), MFR REPORT #: 1219930-2015-00844, (B)(4). LITERATURE: SALMINEN, H.J., TAN, W.S., JAYNE, D.G. THREE CASES OF SMALL BOWEL OBSTRUCTION AFTER LAPAROSCOPIC VENTRAL RECTOPEXY USING THE V-LOC SUTURE. TECH COLOPROCTOL. 2014. VOL. 18:601-602. DOI 10.1007/S10151-013-1074-Z. (B)(4). THE PROCODE OF THE DEVICE IS NOT KNOWN AS THE PRODUCT ID IS NOT KNOWN. IT IS PROVIDED THAT THE DEVICE IS AN ABSORBABLE VLOC SUTURE SO IT IS LIKELY THAT THE PROCODE IS ONE OF THE FOLLOWING: VLOC180: K091087,VLOC90: K100257,VLOC DLU (DEVICE LOADING UNIT FOR A HAND INSTRUMENT): K111442.

    Description of Event or Problem · 1

    (B)(4): PATIENT 1, PROCEDURE: LAPAROSCOPIC ASSISTED VENTRAL RECTOPEXY FOR (MED HISTORY) OBSTRUCTED DEFAECATION WITH RECTO-ANAL INTUSSUSCEPTION. (B)(4): PATIENT 2, PROCEDURE: LAPAROSCOPIC ASSISTED VENTRAL RECTOPEXY FOR (MED HISTORY) OBSTRUCTED DEFAECATION WITH RECTO-ANAL INTUSSUSCEPTION. (B)(4): PATIENT 3, PROCEDURE: RESECTION RECTOPEXY INCORPORATING SACROCOLPORECTOPEXY FOR (MED HISTORY) RECURRENT RECTAL PROLAPSE. ACCORDING TO THE AUTHOR: "WE HAVE BEEN USING THE V-LOC 180 SUTURE FOR PERITONEAL CLOSURE DURING LAPAROSCOPIC VENTRAL RECTOPEXY. WE HAVE FOUND THAT THE SUTURE WAS EASY TO USE FOR PERITONEAL CLOSURE TO COVER THE IMPLANTED MESH. HOWEVER, IN THREE CASES WHERE V-LOC WAS USED, PATIENTS SUBSEQUENTLY DEVELOPED SMALL BOWEL OBSTRUCTION REQUIRING RE-INTERVENTION. IN EACH CASE, THE CAUSE OF OBSTRUCTION WAS FOUND TO BE SMALL BOWEL OR OMENTUM STUCK TO THE DISTAL CUT END OF V-LOC AT THE SACRAL PROMONTORY. WE HAVE NOT FOUND ANY SIMILAR REPORTS IN THE LITERATURE AND PRESENT THE FOLLOWING CASES TO ALERT THE WIDER SURGICAL COMMUNITY. TWO PATIENTS UNDERWENT LAPAROSCOPIC VENTRAL RECTOPEXY FOR OBSTRUCTED DEFAECATION WITH RECTO-ANAL INTUSSUSCEPTION. THE THIRD PATIENT UNDERWENT RESECTION RECTOPEXY INCORPORATING SACROCOLPORECTOPEXY FOR RECURRENT RECTAL PROLAPSE. THE V-LOC 180 SUTURE WAS USED FOR PERITONEAL CLOSURE, WITH THE CUT END OF THE SUTURE DELIBERATELY LEFT LONG (2-3 CM) TO ENSURE ADEQUATE FIXATION AT THE TERMINATION OF SUTURING. THE PATIENTS PRESENTED WITH MECHANIAL SMALL BOWEL OBSTRUCTION, PROVEN ON COMPUTED TOMOGRAPHY (CT) SCAN. TIME TO DEVELOPMENT OF SMALL BOWEL OBSTRUCTION WAS 1 WEEK, 1 MONTH AND 4 MONTHS POSTOPERATIVELY. FIGURE 1 SHOWS THE CT SCAN IMAGE OF MECHANICAL SMALL BOWEL OBSTRUCTION WITH A TRANSITION POINT NEAR THE LEVEL OF THE SACRAL PROMONTORY, IN THE VICINITY OF THE CUT DISTAL END OF THE V-LOC SUTURE. PATIENT 1 HAD A BAND OF OMENTUM CAUGHT IN THE BARBS OF THE SUTURE, CAUSING A KINK IN A LOOP OF SMALL BOWEL. THE OMENTAL BAND WAS DIVIDED AND NO BOWEL RESECTION WAS REQUIRED. PATIENTS 2 AND 3 HAD A LOOP OF SMALL BOWEL CAUGHT BY THE BARBS OF THE SUTURE, WITH AN IMPRINT ON THE BOWEL SEROSA CAUSING A FUNCTIONAL OBSTRUCTION. RELEASE OF SMALL BOWEL AND TRIMMING OF SUTURE WERE PERFORMED IN ALL CASES. ALL 3 PATIENTS RECOVERED WITHOUT FURTHER COMPLICATIONS. MECHANICAL SMALL BOWEL OBSTRUCTION CAUSES CONSIDERABLE MORBIDITY AND ALMOST ALWAYS REQUIRES INTERVENTION. THESE 3 CASES HIGHLIGHT THE RISK OF SMALL BOWEL OBSTRUCTION AS A COMPLICATION RESULTING FROM THE USE OF V-LOC. THE OPERATIVE FINDINGS STRONGLY SUGGEST THAT THIS WAS THE RESULT OF THE SUTURE END BEING LEFT TOO LONG, ALLOWING SMALL BOWEL AND OMENTUM TO STICK TO THE BARBS OF THE SUTURE AND CAUSING A FUNCTIONAL OBSTRUCTION; I.E., THE SUTURE WAS NOT PHYSICALLY RESTRICTING THE BOWEL LUMEN, BUT RATHER THE INTERACTION OF BOWEL AND BARBED SUTURE APPEARED TO CAUSE A LOCALIZED ILEUS. THIS UNDERLINES THE NEED TO CUT THE SUTURE END SHORT AND TO ENSURE THAT NO SUTURE MATERIAL IS LEFT EXPOSED. ON REVIEW OF THE PRODUCT INFORMATION SHEET, IT IS MENTIONED IN SMALL PRINT THAT THE SUTURE END SHOULD BE CUT FLUSH WHEN USED FOR DEEP TISSUE STITCHING, ALTHOUGH NO FURTHER INFORMATION IS GIVEN. IN VIEW OF OUR EXPERIENCE, WE SUGGEST THAT THE MANUFACTURERS TAKE GREATER STEPS TO EMPHASIZE THE NEED TO ENSURE NO SUTURE MATERIAL IS LEFT EXPOSED AND HIGHLIGHT THE POTENTIAL FOR SMALL BOWEL OBSTRUCTION IN THE EVENT THAT SUTURE MATERIAL COMES INTO CONTACT WITH BOWEL. SUBSEQUENT TO THESE 3 CASES, WE HAVE CONTINUED TO USE THE V-LOC BECAUSE OF ITS BENEFITS, BUT HAVE ENSURED THAT ALL SUTURES ARE CUT FLUSH WITH THE TISSUE, AND WE HAVE NOT HAD ANY FURTHER OCCURRENCES OF BOWEL OBSTRUCTION." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT AS OF YET NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642533 UNKNOWN VLOC PRODUCT BARBED UNIDIRECTIONAL LOOPED ABSORBABLE SURGICAL SUTURE GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN-VLOC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention