BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO ST

    MDR report key: 15892580 · Received December 1, 2022

    Report

    Report Number
    1213643-2022-00765
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    September 29, 2015
    Report Date
    February 7, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K101920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE. AS REPORTED, PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS. THE REPORTED COMPLICATIONS ARE KNOWN INHERENT RISKS OF SURGERY/USE OF THE DEVICE. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE IDENTIFIES SEROMA, HEMATOMA, PAIN, INFECTION, AND RECURRENCE OF THE HERNIA AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE PROSTHESIS. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE PROSTHESIS." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS MDR REPRESENTS THE VENTRIO ST MESH. ADDITIONAL MDRS WERE SUBMITTED TO REPRESENT SEPRAMESH IP, VENTRALIGHT ST MESH AND VENTRALIGHT ST W/ECHO PS. NOTE, THE DATE OF EVENT ((B)(6) 2012) IS PROVIDED AS AN ESTIMATE BASED ON THE INFORMATION PROVIDED. NOT RETURNED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE. AS REPORTED, PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS. THE REPORTED COMPLICATIONS ARE KNOWN INHERENT RISKS OF SURGERY/USE OF THE DEVICE. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE IDENTIFIES SEROMA, HEMATOMA, PAIN, INFECTION, AND RECURRENCE OF THE HERNIA AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE PROSTHESIS. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE PROSTHESIS." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDENDIUM: THE ADVERSE EVENT WAS NOT RELATED TO THE THE DEVICE OR THE WAY THE DEVICE WAS USED. THE ADDITIONAL INFORMATION PROVIDED BY THE SURGEON CONFIRMED THAT THE HERNIA RECURRENCES LISTED IN THE JOURNAL ARTICLE WERE OUTSIDE OF THE INITIAL HERNIA REPAIR AREA, AND WERE NOT CAUSED OR CONTRIBUTED BY ANY ISSUE WITH THE INITIAL IMPLANTED HERNIA MESH. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON COMBINED WITH THE DETAILS IN THE JOURNAL ARTICLE, THERE IS NO ALLEGATION OR INDICATION THAT THE SEROMA, HEMATOMA, AND INFECTION OUTCOMES INCLUDED IN THE ARTICLE ARE MESH RELATED. THIS MDR REPRESENTS THE JOURNAL ARTICLE¿S ¿SECOND CASE¿ HERNIA RECURRENCE, VENTRIO ST DEVICE. ACTUAL PRODUCT REMAINS UNKNOWN, VENTRIO ST REPRESENTS A POTENTIAL PRODUCT BASED ON THE INFORMATION PROVIDED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : NOT RETURNED

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE IN HERNIA (2022) TITLED, ¿SEVEN YEARS OF PREOPERATIVE BTA ABDOMINAL WALL PREPARATION AND THE MACQUARIE SYSTEM FOR SURGICAL MANAGEMENT OF COMPLEX VENTRAL HERNIA.¿ FEATURED WAS A SINGLE-CENTER PROSPECTIVE COHORT STUDY BETWEEN NOVEMBER 2012 AND DECEMBER 2019, 88 CONSECUTIVE PATIENTS UNDERWENT COMPLEX VENTRAL HERNIA (CVH) REPAIR USING PRE-OPERATIVE BOTULINUM TOXIN A (BTA) INJECTION AND THE MACQUARIE SYSTEM OF MANAGEMENT WITH BARD/DAVOL SEPRAMESH, VENTRIO ST, VENTRALIGHT ST AND VENTRALIGHT ST W/ECHO PS. CLINICAL EXAMINATION AND FUNCTIONAL NON-CONTRAST ABDOMINAL CT SCANS, ULTRASOUNDS WERE USED TO ASSESS COMPLICATIONS AND RECURRENCES ENCOUNTERED. SURGICAL COMPLICATIONS OCCURRED IN 22 (25.0%) PATIENTS. RECURRENCE 2 (2.3%), HEMATOMA (REQUIRED INTERVENTION) 2 (2.3%), SEROMA 7 (8.0% REQUIRED ASPIRATIONS), INFERIOR EPIGASTRIC ARTERY BLEED 1 (1.1% REQUIRED EMBOLIZATION), ONE (1.1%) PATIENT HAD A SUPERFICIAL SURGICAL SITE INFECTION MANAGED WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE, SUTURE IRRITATION 1(1.1%). IT WAS ALSO REPORTED THAT A PATIENT DEVELOPED CENTRAL ABDOMINAL PAIN 9 MONTHS AFTER THE OPERATION. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. THIS FILE IS FILED TO DOCUMENT THE VENTRIO ST.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE IN SPRINGER-VERLAG JUNE 2021 TITLED, ¿SEVEN YEARS OF PREOPERATIVE BTA ABDOMINAL WALL PREPARATION AND THE MACQUARIE SYSTEM FOR SURGICAL MANAGEMENT OF COMPLEX VENTRAL HERNIA.¿: THE STUDY INCLUDED 88 PATIENTS TREATED FOR A COMPLEX VENTRAL HERNIA (CVH) DURING A 7-YEAR PERIOD. ALL HERNIA DEFECTS WERE SUCCESSFULLY CLOSED USING EITHER LAPAROSCOPIC OR LAPAROSCOPIC-ASSISTED OPEN TECHNIQUES FACILITATED BY PRE-OPERATIVE BOTULINUM TOXIN A (BTA) INJECTION. ALL LAPAROSCOPIC REPAIRS USED A BARD SEPRAMESH IP OR A BARD VARIANT OF THE SEPRAMESH (BARD HERNIA MESH WITH A ST COATING COMPONENT). THE ARTICLE IDENTIFIES: (A) THERE WERE NO BTA COMPLICATIONS; (B) POST-OPERATIVE WOUND-RELATED COMPLICATIONS (WITH NO ALLEGATION/INDICATION OF BEING DEVICE RELATED) INCLUDED 7 PATIENTS WITH SEROMAS AND 2 PATIENTS WITH HEMATOMAS REQUIRING INTERVENTION; (C) 2 PATIENTS WHO DEVELOPED HERNIA RECURRENCES. ADDENDIUM: PER JOURNAL ARTICLE IN SPRINGER-VERLAG JUNE 2021 TITLED, ¿SEVEN YEARS OF PREOPERATIVE BTA ABDOMINAL WALL PREPARATION AND THE MACQUARIE SYSTEM FOR SURGICAL MANAGEMENT OF COMPLEX VENTRAL HERNIA.¿: THE STUDY INCLUDED 88 PATIENTS TREATED FOR A COMPLEX VENTRAL HERNIA (CVH) DURING A 7-YEAR PERIOD. ALL HERNIA DEFECTS WERE SUCCESSFULLY CLOSED USING EITHER LAPAROSCOPIC OR LAPAROSCOPIC-ASSISTED OPEN TECHNIQUES FACILITATED BY PRE-OPERATIVE BOTULINUM TOXIN A (BTA) INJECTION. ALL LAPAROSCOPIC REPAIRS USED A BARD SEPRAMESH IP OR A BARD VARIANT OF THE SEPRAMESH (BARD HERNIA MESH WITH A ST COATING COMPONENT). THE ARTICLE IDENTIFIES: (A) THERE WERE NO BTA COMPLICATIONS; (B) POST-OPERATIVE WOUND-RELATED COMPLICATIONS (WITH NO ALLEGATION/INDICATION OF BEING DEVICE RELATED) INCLUDED 7 PATIENTS WITH SEROMAS AND 2 PATIENTS WITH HEMATOMAS REQUIRING INTERVENTION; (C) 2 PATIENTS WHO DEVELOPED HERNIA RECURRENCES. ARTICLE HERNIA RECURRENCE SUMMARY: THE RECURRENCE RELATED TO THE SECOND CASE NOTED THE PATIENT HAD DEVELOPED CENTRAL ABDOMINAL PAIN 9 MONTHS AFTER THE OPERATION BUT DID NOT DEVELOP ANY CORRESPONDING CLINICAL BULGE UNTIL 12 MONTHS AFTER THE OPERATION. CT OBTAINED AT THIS POINT SHOWED A 4 CM ¿SWISS-CHEESE¿ SUPRA-UMBILICAL HERNIA LOCATED ABOVE THE MESH OF REPAIR. THE HERNIA ¿FIELD¿ INCLUDED MULTIPLE FASCIAL DEFECTS ON THE BACKGROUND OF A WIDENED LINEA ALBA. THIS RECURRENCE WAS MANAGED WITH A LAPAROSCOPIC RECONSTRUCTION OF THE ABDOMINAL MIDLINE FROM THE LEVEL OF XIPHISTERNUM TO THE PREVIOUS REPAIR USING POLYPROPYLENE SEPRAFILM COMPOSITE MESH IN THE IPOM POSITION. ADDENDUM PER ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON REGARDING THE "SECOND CASE": ¿THIS PATIENT¿S RECURRENCE WAS OUTSIDE THE MESH/RECONSTRUCTION AREA & REPRESENTED A FAILURE BY THE SURGICAL TEAM (US) TO EXTEND THE HERNIA REPAIR AND MESH WELL BEYOND THE PRIMARY DEFECT. CLINICALLY THE PATIENT WAS WELL WITH NO HERNIA SYMPTOMS AT LAST REVIEW.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769986 VENTRIO ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention