BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - VENTRALEX

    MDR report key: 2132566 · Received June 10, 2011

    Report

    Report Number
    1213643-2011-00274
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    August 13, 2006
    Report Date
    May 15, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K021736
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S ATTORNEY INITIALLY REPORTED A COMPOSIX KUGEL MESH, WHICH WAS FILED WITH THE FDA IN ACCORDANCE WITH (B)(4) WHEN DAVOL WAS ORIGINALLY MADE AWARE OF THE COMPLAINT IN 2009. HOWEVER, MEDICAL RECORDS WERE LATER RECEIVED THAT IDENTIFIED AN ADDITIONAL MESH. BASED ON A REVIEW OF THE MEDICAL RECORDS, THE PT WAS TREATED FOR A VENTRAL INCISIONAL HERNIA WITH A COMPOSIX KUGEL MESH EIGHT MONTHS AFTER UNDERGOING A RIGHT HEMICOLECTOMY AND A PROCEDURE SHORTLY AFTER THAT FOR LYSIS OF ADHESIONS, ABSCESS DRAINAGE, AND DIVERTING LOOP ILEOSTOMY PLACEMENT. DURING THE IMPLANT PROCEDURE ON (B)(6) 2005, MULTIPLE HERNIA DEFECTS WERE FOUND, AND THE INCISIONAL SITE WAS NOTED TO BE ATTENUATED AND HERNIATED. IT WAS ALSO NOTED THAT THE STOMACH WAS ADHERENT TO THE ANTERIOR WALL. ON (B)(6) 2006, A VENTRALEX MESH WAS USED TO REPAIR A RECURRENT HERNIA LATERAL TO THE PREVIOUS REPAIR. THE COMPOSIX KUGEL MESH WAS LEFT IN PLACE, AND THERE WAS NO MENTION OF A DEVICE FAILURE DURING THAT PROCEDURE. DURING AN EXPLORATORY LAPAROTOMY ON (B)(6) 2006, THE PT WAS FOUND TO HAVE A SMALL BOWEL OBSTRUCTION. IT WAS NOTED THAT THE MESH HAD BENT DOWNWARD TOWARD THE BOWEL AND HAD ENCROACHED AND ERODED INTO THE BOWEL WALL. IT WAS UNCLEAR WHICH MESH WAS BEING REFERRED TO REGARDING THE ADHERENCE, HOWEVER, BOTH MESHES WERE ULTIMATELY REMOVED. ADHESIONS HAD ALSO FORMED BETWEEN THE BOWELS THEMSELVES, CAUSING OTHER ADHESIONS IN THE FORMED CICATRIX. ON (B)(6) 2008, THE PT UNDERWENT REPAIR OF RECURRENT HERNIA. FOUR HERNIA DEFECTS WERE REPAIRED WITH A COMPOSIX L/P MESH. IT WAS NOTED THAT THERE WAS A LOT OF SMALL BOWEL STUCK TO THE UNDERSIDE OF THE ANTERIOR ABDOMINAL WALL. THERE IS NO MENTION OF A DEVICE ISSUE WITH THE COMPOSIX L/P. IT IS UNK WHETHER THE BARD MESH HAVE CONTRIBUTED TO THE ALLEGED EVENT. THE PT HAS A HISTORY OF ADHESIONS WITH AND WITHOUT MESH. BOTH ADHESION AND RECURRENCE ARE LISTED AS POSSIBLE ADVERSE REACTIONS IN THE PRODUCT'S IFU. A MANUFACTURING REVIEW FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. WITH THE INFO AVAILABLE, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVED BY PT'S ATTORNEY: (B)(6) 2005 -- LAPAROSCOPIC-ASSISTED RIGHT HEMICOLECTOMY. ON (B)(6) 2005 -- EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, DRAINAGE OF ABSCESS, GASTROSTOMY TUBE INSERTION, AND DIVERTING LOOP OF ILEOSTOMY PLACEMENT. ON (B)(6) 2005 -- LAPAROSCOPIC WITH CONVERSION TO OPEN VENTRAL INCISIONAL HERNIA REPAIR ITCH COMPOSIX KUGEL MESH. MULTIPLE ADHESIONS AND HERNIA DEFECTS FOUND. INCISION SITE ATTENUATED AND HERNIATED. STOMACH ADHERENT TO THE ANTERIOR ABDOMINAL WALL IN AN AREA OF PRIOR GASTROSTOMY. ON (B)(6) 2006 -- REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH VENTRALEX MESH. ON (B)(6) 2006 -- EXPLORATORY LAPAROTOMY, EXTENSIVE ELECTROLYSIS, RELEASE OF BOWEL OBSTRUCTION, REMOVAL OF MESH, MULTIPLE ENTERORRHAPHY. MESH ADHERENT TO SMALL BOWEL SURFACE. ADHESIONS ALSO NOTED BETWEEN THE BOWELS THEMSELVES. ON (B)(6) 2008 -- REPAIR OF RECURRENT VENTRAL HERNIA WITH BARD COMPOSIX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - VENTRALEX FTL DAVOL INC NA 43JOD400

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention INFORMATION BASED ON MEDICAL RECORD REVIEW.| NOTE: SEE MEDICAL RECORD REVIEW FOR ADDITIONAL