MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number	1152025
Medical Device Problem Codes	Material Separation (1562); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bowel Perforation (2668); Fluid Discharge (2686)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient with a history of gsw wound and multiple abdominal surgeries, experienced bilious fluid leakage at the surgical site and underwent subsequent surgical intervention one day post implant of the xenmatrix ab graft.It is alleged that during this procedure a defect was noted in the graft and there was a small bowel injury to the bowl underlying this area.Reportedly, the graft was partially explanted at this time.Photos of the alleged defect were not provided, nor was the ¿defect¿ reported to have been present prior to implantation.Based on the information provided, no conclusion can be made as to the degree to which the bard device, may have caused or contributed to the patient¿s reported postoperative course.Review of manufacturing records indicate the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june, 2019.Should additional information be provided, a supplemental mdr will be submitted.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 - mesh explanted.
Event or Problem Description
As reported per medwatch report (2400040000-2021-8004) alleging adverse outcomes against bard/davol xenmatrix ab graft: "patient went to the or for exploratory abdominal laparotomy, ileostomy takedown, ventral hernia repair with without and bilateral ureteral stent placement.The next day, patient was brought back to the or for bilious leakage at the surgical site.We began by examining the ileostomy site wound and noted a likely defect in the mesh (xenmatrix ab graft).We removed all of the previously placed staples from the midline to better visualize the mesh.We identified a 5cm linear defect in the right lower quadrant mesh that was completely separate from the edge of the mesh and not related to any needle hole defects.We could see bowel underneath and noted bilious fluid, concerning for bowel injury.We made plans to remove the mesh for better visualization; all of the previously placed circumferential prolene sutures were removed and the mesh was removed from the abdomen.We then identified a several millimeter wide full-thickness small bowel injury in the bowel that had been underlying the area of compromised mesh." addendum per additional information: as reported per contact, the patient had the xenmatrix ab graft implanted on (b)(6) 2020 and was brought back to the or for the bilious leakage on (b)(6) 2020.It was noted that the mesh ¿failed¿ and it was removed (partially).It was reported that there were no other known contributing factors to the patient condition, such as, there were no serosal tears or other bowel injuries incurred during the initial procedure.Contact reports it is unknown exactly how the xenmatrix ab contributed to the adverse patient outcome.
Additional Manufacturer Narrative
As reported, the patient with a history of gsw wound and multiple abdominal surgeries, experienced bilious fluid leakage at the surgical site and underwent subsequent surgical intervention one day post implant of the xenmatrix ab graft.It is alleged that during this procedure a defect was noted in the graft and there was a small bowel injury to the bowl underlying this area.Reportedly, the graft was partially explanted at this time.Photos of the alleged defect were not provided, nor was the ¿defect¿ reported to have been present prior to implantation.Based on the information provided, no conclusion can be made as to the degree to which the bard device, may have caused or contributed to the patient¿s reported postoperative course.Review of manufacturing records indicate the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june, 2019.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document corrections to the fields listed below.Should additional information be provided, a supplemental mdr will be submitted.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 - mesh explanted.
Event or Problem Description
As reported per medwatch report (b)(4) alleging adverse outcomes against bard/davol xenmatrix ab graft: "patient went to the or for exploratory abdominal laparotomy, ileostomy takedown, ventral hernia repair with without and bilateral ureteral stent placement.The next day, patient was brought back to the or for bilious leakage at the surgical site.We began by examining the ileostomy site wound and noted a likely defect in the mesh (xenmatrix ab graft).We removed all of the previously placed staples from the midline to better visualize the mesh.We identified a 5cm linear defect in the right lower quadrant mesh that was completely separate from the edge of the mesh and not related to any needle hole defects.We could see bowel underneath and noted bilious fluid, concerning for bowel injury.We made plans to remove the mesh for better visualization; all of the previously placed circumferential prolene sutures were removed and the mesh was removed from the abdomen.We then identified a several millimeter wide full-thickness small bowel injury in the bowel that had been underlying the area of compromised mesh." addendum per additional information: as reported per contact, the patient had the xenmatrix ab graft implanted on 10-nov-2020 and was brought back to the or for the bilious leakage on 11-nov-2020.It was noted that the mesh ¿failed¿ and it was removed (partially).It was reported that there were no other known contributing factors to the patient condition, such as, there were no serosal tears or other bowel injuries incurred during the initial procedure.Contact reports it is unknown exactly how the xenmatrix ab contributed to the adverse patient outcome.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11313072
• Report Number: 1213643-2021-20025
• Device Sequence Number: 2737217
• Product Code: PIJ
• UDI-Device Identifier: 00801741074288
• UDI-Public: (01)00801741074288
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2021
• Device Catalogue Number: 1152025
• Device Lot Number: HUCX3087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 93