BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 15892572 · Received December 1, 2022

    Report

    Report Number
    1213643-2022-00764
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    October 28, 2021
    Report Date
    February 1, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031496
    PMA / PMN Number
    K101928
    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 VENTRALIGHT ST MESH. ADDITIONAL MDRS WERE SUBMITTED TO REPRESENT SEPRAMESH IP, VENTRIO 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. 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. 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 ¿FIRST CASE¿ HERNIA RECURRENCE, VENTRALEX ST DEVICE. 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 VENTRALIGHT ST.

    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 VENTRALIGHT ST. ADDENDUM: 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 FIRST CASE, WAS SUGGESTED ON ROUTINE PROGRESS ULTRASOUND AND CONFIRMED ON CT IMAGING 26 MONTHS AFTER THE CVH REPAIR. THERE WAS NO CLINICALLY DETECTABLE BULGE AND THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF IMAGING DIAGNOSIS. THE RECURRENCE WAS A SINGLE 3 CM MIDLINE DEFECT IN THE SUPRAUMBILICAL REGION JUST SUPERIOR TO THE UPPER BORDER OF THE MESH ALONG WITH A SMALL FATTY EPIGASTRIC HERNIA. THIS HAS BEEN MANAGED EXPECTANTLY WITH NO CHANGE IN SIZE OR SYMPTOMS OVER 63 MONTHS OF SUBSEQUENT FOLLOW-UP. PER ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON REGARDING: THE FIRST CASE HERNIA RECURRENCE PATIENT¿S RECURRENCES WERE OUTSIDE THE INITIAL MESH/RECONSTRUCTION AREA & REPRESENTED A FAILURE BY THE SURGICAL TEAM TO EXTEND THE HERNIA REPAIR AND MESH WELL BEYOND THE INITIAL PRIMARY DEFECT TO COVER ALL HER PREVIOUS ABDOMINAL WALL INCISIONS AND PORT-SITES IN THE OPERATION IN (B)(6) 2016. AT THE SECOND OPERATION ((B)(6) 2021) IT WAS NOTED THAT THERE WAS NO FAILURE OF MESH OR DIRECT MESH COMPLICATION. THE (B)(6) 2021 CVH REPAIR INCLUDED THE IMPLANT OF 3 ADDITIONAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769978 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUZH1921 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention