XENMATRIX 1161935Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741031441), received between Mar 28, 2017 and Jul 9, 2025 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH TWO INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1, DEVICE #2). PER OP NOTES, ¿A SEPRAMESH IP (DEVICE #1) WAS PLACED TO ANTERIOR ABDOMINAL WALL AND SECURED USING TACKER. ANOTHER PIECE OF SEPRAMESH IP (DEVICE #2) WAS PLACED TO LEFT LOWER QUADRANT HERNIA DEFECT AND TACKED WITH SORBAFIX.¿ (B)(6) 2012 ¿ PATIENT HAD ABDOMINAL PAIN AND DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #3). PER OP NOTES, ¿EXTENSIVE MIDLINE AND LEFT LOWER QUADRANT ADHESIONS NOTED TO THE UNDERSURFACE OF THE PRIOR MESH (DEVICE #1, #2) WAS TAKEN DOWN. HERNIA DEFECT WAS NOTED IN THE MIDLINE. A VENTRALIGHT ST (DEVICE #3) WAS PLACED INTO ANTERIOR ABDOMINAL WALL AND TACKED USING SORBAFIX.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH WOUND INFECTION THEREBY UNDERWENT INCISION AND DRAINAGE OF WOUND INFECTION AND PURULENT DRAINAGE WAS NOTED IN MID ABDOMEN. (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INFECTED VENTRAL HERNIA MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2, #3) AND IMPLANT OF XENMATRIX (D

  Patient problems: Adhesion(s); Drug Resistant Bacterial Infection; Wound Dehiscence

  MAUDE report 22455758 ↗
• InjurySep 3, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD SOFT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A DEFECT WAS IDENTIFIED. THE BOWEL THAT WAS ADHERENT TO IT WAS FREED SHARPLY AND THERE WAS NO EVIDENCE OF ANY ISCHEMIC BOWEL. AN ONLAY BARD SOFT MESH (DEVICE #1) WAS SUTURED IN PLACE.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA, PAIN AND POSSIBLE PARTIAL SMALL-BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRALIGHT ST MESHES (DEVICE #2 & #3). PER OPERATIVE NOTES, ¿THERE WAS A COMBINATION OF HERNIA SAC AND MESH. SCAR TISSUE WAS INCISED OFF THE MESH AND ALL THE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WERE THEN REMOVED. THERE WAS A LARGE DEFECT IN WHICH THE MESH (DEVICE #1) WAS QUITE SUPERFICIAL THAT COULD NOT BE REMOVED. A VENTRALEX ST MESH (DEVICE #2 & #3) WAS PLACED AS IT REQUIRED TWO PIECES BECAUSE OF THE WOUND SIZE.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRIO ST MESHES (DEVICE #4 & #5). PER OPERATIVE NOTES, ¿THERE WAS A LARGE SEROMA

  Patient problems: Insufficient Information

  MAUDE report 20123908 ↗
• InjuryFeb 21, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #1). (NOTE: THERE WAS NO OPERATIVE NOTES PROVIDED). (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SEVERE ABDOMINAL PAIN, SEPSIS, RECURRENT INCISIONAL HERNIA WITH EQUIVOCAL FINDINGS OF STRANGULATION AND PERFORATION THEREBY UNDERWENT EXPLORATORY LAPAROTOMY WITH EXPLANT OF BARD FLAT MESH (DEVICE #1) AND TRANSVERSE COLECTOMY. PER OPERATIVE NOTES, ¿THE OLD MESH (DEVICE #1) UNDERLYING HERNIA SAC CONTAINING INCARCERATED, STRANGULATED COLON WAS ENCOUNTERED. THE HERNIA SAC WAS COMPLEX CONTAINING OMENTUM AND A LOOP OF NECROTIC TRANSVERSE COLON. THE FASCIAL DEFECT WAS ENLARGED SUPERIORLY AND INFERIORLY TO ACHIEVE REDUCTION. EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED AND A LARGE SUBACUTE/CHRONIC ABSCESS CAVITY WAS ENCOUNTERED. THE OLD MESH (DEVICE #1) WAS REMOVED IN ITS ENTIRETY. A DIVERTING LOOP ILEOSTOMY WAS THEN CREATED IN THE RIGHT LOWER QUADRANT.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH PERFORATED AFFERENT LIMB OF LOOP ILEOSTOMY AT THE FASCIAL LEVEL THEREBY UNDERWENT REPAIR. (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR

  Patient problems: Abdominal Pain; Unspecified Infection

  MAUDE report 18746912 ↗
• InjurySep 7, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL XENMATRIX ON (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE XENMATRIX. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Erosion; Insufficient Information; Necrosis; Pain; Post Operative Wound Infection

  MAUDE report 15367876 ↗
• InjurySep 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2015, THE PATIENT UNDERWENT AN OPEN FIRST-TIME RECURRENT MIDLINE VENTRAL HERNIA REPAIR DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION, INTRA-PERITONEALLY USING OPEN COMPONENT SEPARATION TECHNIQUE (CST) METHOD AND WAS FIXATED USING MAXON SUTURES. THE HERNIA SITE WOUND WAS NOTED TO BE A CLASS II (CLEAN - CONTAMINATED) SITE. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED USING VICRYL INTERRUPTED STITCH AND STAPLES. CONCOMITANT PROCEDURES INCLUDED LYSIS OF ADHESIONS, OSTOMY CREATION/REVISION/REVERSAL AND MUCOSA FISTULA TAKEDOWN. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. AS REPORTED, THE PATIENT DIAGNOSED WITH SURGICAL SITE INFECTION (SSI) ON (B)(6) 2016 WITH PURULENT DRAINAGE FROM THE SUPERFICIAL INCISION, WAS TREATED WITH ORAL ANTIBIOTICS WHICH RESOLVED ON (B)(6) 2016. PER THE STUDY CLINICIAN, THE REPORTED AE (SURGICAL SITE INFECTION (SSI)) HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE INDEX PROCEDURE AND HAS RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 15339983 ↗
• InjuryAug 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2015, THE SUBJECT PATIENT UNDERWENT FIRST TIME RECURRENT MIDLINE INCISIONAL OPEN HERNIA REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY, FIXATED USING MAXON SUTURES WITH INTERRUPTED STITCH TECHNIQUE. THE FASCIA CLOSURE WAS ACHIEVED USING VICRYL SUTURES WITH INTERRUPTED STITCH TECHNIQUE AND FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. CONCOMITANT PROCEDURE INCLUDES LYSIS OF ADHESION(S) AND BOWEL RESECTION. ON (B)(6) 2015, THE SUBJECT PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION AND ABSCESS. THE PATIENT UNDERWENT DRAINAGE CULTURE TEST, RESULTED IN POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE PATIENT WAS HOSPITALIZED AND UNDERWENT DRAIN INSERTION USING INTERVENTIONAL RADIOLOGY, AND TREATED WITH ORAL ANTIBIOTICS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2015 AND THE AE WAS RESOLVED ON (B)(6) 2016. ON (B)(6) 2016, THE SUBJECT PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION AND ABSCESS. THE PATIENT UNDERWENT DRAINAGE CULTURE TEST, WHICH RESULTED IN NO IDENTIFICATION OF PATHOGENS. THE PATIENT WAS

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 15294391 ↗
• InjuryAug 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2015, THE PATIENT UNDERWENT PRIMARY OPEN MIDLINE VENTRAL HERNIA REPAIR DURING WHICH XENMATRIX SURGICAL GRAFT (DEVICE #1) WAS TRIMMED AND PLACED USING UNDERLAY TECHNIQUE IN INTRA-PERITONEAL REGION AND FIXATED USING SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING MAXON SUTURES WITH INTERRUPTED STITCH. THE PATIENT WAS DISCHARGED (B)(6) 2015. AS REPORTED, THE PATIENT WAS DIAGNOSED WITH WOUND DEHISCENCE (B)(6) 2015 AND ADMITTED IN THE HOSPITAL. ON (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR WOUND DEHISCENCE AND GIVEN IV ANTIBIOTICS, DEBRIDEMENT, WOUND CARE AND WOUND VAC WAS PLACED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. AS REPORTED, THE PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA ON (B)(6) 2015 AND ADMITTED IN THE HOSPITAL. AS REPORTED THE PATIENT WAS TREATED WITH TPN (TOTAL PARENTERAL NUTRITION). THE PATIENT WAS DISCHARGED (B)(6) 2015. AS REPORTED, (B)(6) 2015. THE PATIENT WAS DIAGNOSED WITH MIDLINE VENTRAL HERNIA RECURRENCE AND EC FISTULA. AS REPORTED, THE PATIENT UNDERWENT SURGERY FOR HERNIA RECURRENCE, WOUND DEHISCENCE & FISTULA ON (B)(6) 2015 DURING WHICH ANOTHER XENMATRIX SURGICAL GRAFT, (DEVICE #2) WAS IMPLANTED AND FIXATED USING S

  Patient problems: Fistula; Hernia; Wound Dehiscence

  MAUDE report 15282770 ↗
• InjuryAug 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2015, THE PATIENT UNDERWENT PRIMARY OPEN MIDLINE VENTRAL HERNIA REPAIR DURING WHICH XENMATRIX SURGICAL GRAFT (DEVICE #1) WAS TRIMMED AND PLACED USING UNDERLAY TECHNIQUE IN INTRA-PERITONEAL REGION AND FIXATED USING SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING MAXON SUTURES WITH INTERRUPTED STITCH. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. AS REPORTED, THE PATIENT WAS DIAGNOSED WITH WOUND DEHISCENCE ON (B)(6) 2015 AND ADMITTED IN THE HOSPITAL. ON (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR WOUND DEHISCENCE AND GIVEN IV ANTIBIOTICS, DEBRIDEMENT, WOUND CARE AND WOUND VAC WAS PLACED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. AS REPORTED, THE PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA ON (B)(6) 2015 AND ADMITTED IN THE HOSPITAL. AS REPORTED THE PATIENT WAS TREATED WITH TPN (TOTAL PARENTERAL NUTRITION). THE PATIENT WAS DISCHARGED ON (B)(6) 2015. AS REPORTED, ON (B)(6) 2015 THE PATIENT WAS DIAGNOSED WITH MIDLINE VENTRAL HERNIA RECURRENCE AND EC FISTULA. AS REPORTED, THE PATIENT UNDERWENT SURGERY FOR HERNIA RECURRENCE, WOUND DEHISCENCE & FISTULA ON (B)(6) 2015 DURING WHICH ANOTHER XENMATRIX SURGICAL GRAFT, (DEVICE #2) WAS IMPLANTED AND FIXA

  Patient problems: Hernia

  MAUDE report 15282767 ↗
• InjuryAug 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL STUDY DVL-HE-020: ON (B)(6) 2014, THE SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL MIDLINE OPEN HERNIA REPAIR PROCEDURE, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN INLAY FASHION ON THE INTRA-PERITONEAL REGION USING A SUTURE (MAXON). FASCIA WAS COMPLETELY CLOSED WITH VICRYL SUTURE IN INTERRUPTED STITCH TECHNIQUE AND FULL CLOSURE WAS ACHIEVED WITH SUTURES. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. CONCOMITANT PROCEDURE INCLUDES LYSIS OF ADHESION(S) AND PRIOR MESH REMOVAL. AS REPORTED, DURING A PHYSICAL EXAMINATION ON (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH VENTRAL MIDLINE HERNIA RECURRENCE AND CONFIRMED THROUGH CT SCAN ON (B)(6) 2016. ON (B)(6) 2016, PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE DURING WHICH THE DEVICE WAS PARTIALLY EXPLANTED. FASCIA WAS COMPLETELY CLOSED WITH VICRYL SUTURE IN INTERRUPTED STITCH TECHNIQUE AND FULL CLOSURE WAS ACHIEVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. THE AE IS CLINICALLY ASSESSED TO BE OF MODERATE SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE, NOT RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT MEETS THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DO

  Patient problems: Hernia

  MAUDE report 15257808 ↗
• InjuryAug 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2015, THE PATIENT UNDERWENT PRIMARY OPEN HERNIA REPAIR PROCEDURE FOR VENTRAL HERNIA IN LLQ LOCATION DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION IN THE INTRA-PERITONEAL REGION USING SUTURES. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES WITH FIGURE-8 TECHNIQUE. CONCOMITANT PROCEDURE INCLUDES DEBRIDEMENT OF ABDOMINAL WALL NONHEALING WOUND. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. AS REPORTED, DURING A PHYSICAL EXAMINATION ON (B)(6) 2015 THE PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA RECURRENCE IN LLQ LOCATION. AS REPORTED ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION (SSI) AND THE CULTURE TEST FOR THE TISSUE WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS AND TREATED WITH ORAL ANTIBIOTICS/ANTIMICROBIALS AND RESOLVED ON (B)(6) 2016. IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT REOPERATION TO REPAIR HERNIA RECURRENCE AND THE GRAFT WAS REMOVED COMPLETELY. FULL SKIN CLOSURE WAS ACHIEVED USING VICRYL INTERRUPTED STITCH. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. THE AE (HERNIA RECURRENCE AND SURGICAL SITE INFECTION (SSI)) IS CLINICALLY ASSESSED TO BE MODERATE IN SEVERITY, POSSIBLY

  Patient problems: Bacterial Infection; Hernia

  MAUDE report 15257799 ↗
• InjuryAug 11, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ALLEGED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2014, THE SUBJECT PATIENT UNDERWENT A MULTIPLE-RECURRENT OPEN INCISIONAL TRANSVERSE HERNIA (25 CM X 20 CM) REPAIR PROCEDURE, DURING WHICH TWO XENMATRIX SURGICAL GRAFTS (DEVICE #1 & DEVICE #2) WERE TRIMMED AND PLACED IN UNDERLAY FASHION INTRA-PERITONEALLY USING SUTURES. FASCIA WAS COMPLETELY CLOSED WITH VICRYL SUTURE IN INTERRUPTED STITCH TECHNIQUE AND FULL CLOSURE WAS ACHIEVED WITH SUTURES. CONCOMITANT PROCEDURE INCLUDED LYSIS OF ADHESION(S). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA. ON (B)(6) 2015, THE PATIENT UNDERWENT REOPERATION TO REPAIR THE HERNIA, DURING WHICH ANOTHER XENMATRIX SURGICAL GRAFT (DEVICE #3) WAS IMPLANTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. THE AE (HERNIA RECURRENCE) IS CLINICALLY ASSESSED TO BE OF MODERATE SEVERITY, DEFINITELY RELATED TO THE STUDY DEVICE #1 & DEVICE #2, POSSIBLY RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT MET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNLISTED ADVERSE DEVICE EVENT). ON (B)(6) 2015,

  Patient problems: Hernia

  MAUDE report 15209232 ↗
• InjuryAug 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2014, THE PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL SUPRAPUBIC OPEN HERNIA REPAIR PROCEDURE DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION INTER PERITONEALLY, FIXATED USING SUTURES. FASCIA WAS COMPLETELY CLOSED USING SUTURE THROUGH INTERRUPTED STITCH. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. CONCOMITANT PROCEDURE INCLUDES LYSIS OF ADHESION(S). THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT UNDERWENT REMOVAL OF JACKSON PRATT DRAIN AND DISCHARGED ON THE SAME DAY. ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH FISTULA; THE SPONTANEOUS DRAINING SINUS RESOLVED OVER TIME ON (B)(6) 2015, PATIENT UNDERWENT PHYSICAL EXAM DURING WHICH VENTRAL SUPRAPUBIC HERNIA (3.7 CM2) WAS DIAGNOSED AND CONFIRMED THROUGH CT SCAN ON (B)(6) 2015. ON (B)(6) 2015 PATIENT UNDERWENT AN ADDITIONAL SURGERY AND THE DEVICE WAS EXPLANTED. THE FASCIA WAS COMPLETELY CLOSED USING SUTURE THROUGH INTERRUPTED STITCH AND THE SKIN WAS FULLY CLOSED. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. THE AE IS CLINICALLY ASSESSED TO BE OF MODERATE SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE

  Patient problems: Hernia

  MAUDE report 15188629 ↗
• MalfunctionAug 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2014, THE PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL SUPRAPUBIC OPEN HERNIA REPAIR PROCEDURE DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION INTER PERITONEALLY, FIXATED USING A SUTURE. FASCIA WAS COMPLETELY CLOSED USING VICRYL SUTURE THROUGH INTERRUPTED STITCH. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. CONCOMITANT PROCEDURE INCLUDES LYSIS OF ADHESION(S). THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT UNDERWENT REMOVAL OF JACKSON PRATT DRAIN. THE PATIENT WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH FISTULA; THE SPONTANEOUS DRAINING SINUS RESOLVED OVER TIME (B)(6) 2015). THE AE IS CLINICALLY ASSESSED TO BE OF MILD SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE, NOT RELATED TO THE PROCEDURE AND RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT). ON (B)(6) 2015, PATIENT UNDERWENT PHYSICAL EXAM DURING WHICH VENTRAL SUPRAPUBIC HERNIA (3.7 CM2) WAS DIAGNOSED AND CONFIRMED THROUGH CT SCAN ON (B)(6) 2015. ON (B)(6) 2015 PATIENT UNDERWENT AN ADDITIONAL SURGERY AND THE DEVICE WAS EXPL

  Patient problems: Fistula

  MAUDE report 15188328 ↗
• InjuryAug 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2014 THE SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL MIDLINE OPEN HERNIA REPAIR PROCEDURE DURING WHICH A XENMATRIX SURGICAL GRAFT WAS TRIMMED AND PLACED IN UNDERLAY FASHION THROUGH BRIDGING PLACEMENT USING OPEN COMPONENT SEPARATION TECHNIQUE (CST) METHOD, FIXATED USING SUTURES AND FASCIA CLOSURE WAS NOT ACHIEVED DUE TO BRIDGING MESH. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. CONCOMITANT PROCEDURES INCLUDE PANNICULECTOMY, LYSIS OF ADHESION(S), HYSTERECTOMY. ON (B)(6) 2014 , THE SUBJECT PATIENT WAS DIAGNOSED WITH DEEP SURGICAL SITE INFECTION AND WAS TREATED WITH INTRAVENOUS ANTIBIOTICS/ANTIMICROBIALS MEDICATION. ON (B)(6) 2014, THE SUBJECT PATIENT WAS DIAGNOSED WITH VENTRAL MIDLINE HERNIA AND UNDERWENT ADDITIONAL SURGERY. THE GRAFT WAS REMOVED DUE TO DEEP SURGICAL SITE INFECTION AND WOUND DEHISCENCE, THE PATIENT ALSO UNDERWENT EXCISIONAL DEBRIDEMENT OF ABDOMINAL WALL AND SKIN WAS FULLY CLOSED BY WOUND VAC METHOD. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. ABOUT A YEAR LATER, THE WOUND WAS EVENTUALLY CLOSED AFTER SPLIT THICKNESS IN SKIN. THE AE IS CLINICALLY ASSESSED TO BE OF MODER

  Patient problems: Hernia; Unspecified Infection; Wound Dehiscence

  MAUDE report 15181885 ↗
• InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2014, THE SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT OPEN INCISIONAL TRANSVERSE HERNIA REPAIR, DURING WHICH TWO XENMATRIX SURGICAL GRAFTS WERE TRIMMED AND PLACED IN UNDERLAY FASHION ON THE INTRA-PERITONEAL REGION USING A SUTURE. FASCIA WAS COMPLETELY CLOSED WITH VICRYL SUTURE IN INTERRUPTED STITCH TECHNIQUE AND FULL CLOSURE WAS ACHIEVED WITH SUTURES. CONCOMITANT PROCEDURE ABDOMINAL WASH OUT WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2015, THE PATIENT WAS DIAGNOSED WITH RECURRENT HERNIA. ON (B)(6) 2015, THE PATIENT UNDERWENT REOPERATION TO REPAIR RECURRENT INCISIONAL HERNIA AND WAS DISCHARGED TO HOME ON (B)(6) 2015. THIS AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE PROCEDURE AND DEFINITELY RELATED TO THE STUDY DEVICE. THIS HAS BEEN ASSESSED AS A SERIOUS ADVERSE EVENT OF MODERATE SEVERITY AND HAS RECOVERED/RESOLVED. THE REPORTED ADVERSE EVENT MET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNLISTED ADVERSE EVENT).

  Patient problems: Hernia

  MAUDE report 15150992 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2013 THE SUBJECT PATIENT UNDERWENT A PRIMARY OPEN VENTRAL MIDLINE HERNIA REPAIR, DURING WHICH A XENMATRIX SURGICAL GRAFT WAS PLACED IN UNDERLAY FASHION ON THE INTRA-PERITONEAL REGION AND WAS FIXATED USING SUTURES. FULL SKIN CLOSURE WAS ACHIEVED WITH SUTURES. THE PATIENT WAS DISCHARGED TO HOME ON(B)(6) 2014. ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA. ON (B)(6) 2015, THE PATIENT UNDERWENT REOPERATION TO REPAIR RECURRENT VENTRAL HERNIA. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2015. THIS AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS OF MODERATE SEVERITY AND HAS RESOLVED. THE REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Hernia

  MAUDE report 14988341 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2013, THE SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT OPEN VENTRAL MIDLINE HERNIA REPAIR, DURING WHICH A BARD/DAVOL XENMATRIX SURGICAL GRAFT WAS PLACED IN SUBLAY FASHION ON THE RETRO-MUSCULAR REGION WITH SUTURE. FASCIA WAS COMPLETELY CLOSED WITH SUTURE AND FULL CLOSURE WAS ACHIEVED WITH SUTURES. CONCOMITANT PROCEDURE INCLUDES LYSIS OF ADHESION(S), BOWEL RESECTION AND REMOVAL OF PREVIOUS MESH. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013. ON (B)(6) 2014, THE PATIENT WAS DIAGNOSED WITH CHRONIC SEROMA CAVITY. ON (B)(6) 2014, THE PATIENT UNDERWENT AN OPEN VENTRAL MIDLINE HERNIA PROCEDURE FOR SEROMA AND THE SURGICAL GRAFT WAS REMOVED. FASCIA WAS COMPLETELY CLOSED WITH SUTURE AND FULL CLOSURE WAS ACHIEVED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. AS REPORTED, THE ADVERSE EVENT HAS BEEN RESOLVED ON (B)(6) 2014. THIS AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS A NON-SERIOUS ADVERSE EVENT OF MODERATE SEVERITY AND HAS RESOLVED. THIS REPORTED ADVERSE EVENT DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Seroma

  MAUDE report 14988196 ↗
• InjuryJun 17, 2019Material Disintegration; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Disintegration; Material Deformation; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 AND AFTER THE RELEVANT MEDICAL CHECKS, WAS SUBMITTED TO A REHABILITATION SURGERY FOR A PRE-6-MONTH SEVERE GRAVID NECROTIZING PANCREATITIS, WHICH WAS SUCCESSFULLY TREATED. ON (B)(6) 2019 A RESTORATION THE CONTINUITY OF THE DIGESTIVE SYSTEM, I.E. REUNION (ANASTOMOSIS) OF THE RIGHT WITH THE LEFT LARGE INTESTINE AND CLOSURE OF ITS ILEOSTOMY CONVERGENCE. AS WELL AS A RESTORATION OF THE ABDOMINAL WALL GAP THAT WAS LEFT IN THE "OPEN BELLY" TECHNIQUE FROM THE PANCREATITIS PHASE, WITH A BIOLOGICAL MESH (XENMATRIX GRAFT). AFTER A SMOOTH POST-OPERATIVE PERIOD, ON THE DAY OF RELEASE FROM THE HOSPITAL, A LEAK WAS IDENTIFIED FROM THE BOWEL ANASTOMOSIS. TWO DAYS LATER, AFTER BEING EVALUATED BY SPECIAL EXAMINATIONS, UNDERWENT AN OPERATION WHERE THE BOWEL OUTLET WAS TREATED WITH THE GUIDED FISTULA TECHNIQUE TO AVOID NEW ENTEROSTOMY. THE XENMATRIX GRAFT WAS REMOVED AT THAT TIME BECAUSE IT WAS ERODED BY THE LEAKAGE OF THE INTESTINAL CONTENT. THE PATIENT WAS SUBJECTED TO A TOTAL PARENTERAL NUTRITION AND ANTIBIOTIC ADMINISTRATION. ON (B)(6) 2019 BECAUSE THE ESCAPE OF INTESTINAL CONTENTS CONTINUED, ALTHOUGH EMBEDDED, THE PATIENT UNDERWE

  Patient problems: No Code Available

  MAUDE report 8705608 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT REPAIR OF AN ABDOMINAL HERNIA AND WAS IMPLANTED WITH TWO XENMATRIX GRAFTS (DEVICES #1 AND #2), AND A NON BARD/DAVOL BIOLOGIC GRAFT (DEVICE #3). THE CONTACT REPORTS THE HERNIA REPAIR WOUND NEVER FULLY HEALED, AND IN 2014 THE PATIENT DEVELOPED AN INFECTION IN THE AREA OF THE HERNIA REPAIR. AS REPORTED THE PATIENT'S DOCTOR HAS ADVISED HIM THE MESH WILL NEED TO BE REMOVED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 7980497 ↗
• InjuryMar 28, 2017Material Disintegration; Material Disintegration

  THE FOLLOWING WAS REPORTED TO DAVOL AND INCLUDED THE IMPLANT OPERATIVE REPORT: ON (B)(6) 2013- THE PATIENT UNDERWENT AN OPEN VENTRAL HERNIA REPAIR, LAPAROSCOPIC COMPONENT SEPARATION, BILATERAL IMPLANT OF MESH, SKIN FLAP RESECTION AND PLASTIC SURGERY CLOSURE. THE PATIENTS DEFECT IS NOTED TO BE 22CM WIDE X 30CM IN LENGTH. A PREVIOUSLY IMPLANTED, MESH WAS EXPLANTED AT THIS TIME. A COMPONENT SEPARATION WAS PERFORMED TO ALLOW CLOSURE OF THE MIDLINE DEFECT; THE BARD XENMATRIX GRAFT WAS PLACED IN THE RECTORECTUS FASHION AND TRIMMED AS NEEDED. THE OPERATIVE DICTATION ALSO NOTES THAT "A SMALL TEAR IN THE RIGHT SIDE OF THE RECTUS SHEATH WAS REPAIRED USING A LEFTOVER PIECE OF XENMATRIX, WHICH WAS TACKED AS AN ONLAY INTO THIS AREA." THREE FRENCH JP DRAINS WERE PLACED AT THE END OF THE PROCEDURE. THE FOLLOWING IS ADDITIONAL INFORMATION PROVIDED BY THE CONTACT AND IS NOT BASED ON PATIENT MEDICAL RECORDS: ON (B)(6) 2013 - IT IS ALLEGED THE PATIENT DEVELOPED A STAPH INFECTION, THAT WAS LIFE THREATENING AND CLINICALLY SIGNIFICANT. ON (B)(6) 2013 - IT IS ALLEGED THE PATIENT UNDERWENT TWO WOUND CLEANING PROCEDURES, DURING WHICH 25LBS OF MATERIAL WAS REMOVED. AS REPORTED THE XENMATRIX GRAFT HAD BEEN E

  Patient problems: Unspecified Infection

  MAUDE report 6438462 ↗