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

Catalog Number 1152020

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Seroma (2069)

Event Date 12/24/2017

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications (seroma, wound dehiscence) and any problem with the bard/davol xenmatrix ab graft used to treat the patient.As reported the graft was implanted into a contaminated environment and post implant the patient was hospitalized with pneumonia.The study subject is an elderly patient with a complicated medical / surgical history that includes, post operative infections, diabetes, obesity, and prior abdominal wall incisions / surgeries.The adverse events of seroma and wound dehiscence are classified by the study clinician as being possible related to the study device and definitely related to the procedure.The outcome is reported to be recovering / resolving, the graft remains implanted at this time.No definitive conclusion can be made at this time.Seroma formation is a known inherent risk of surgery and is listed in the instructions-for-use, which are provided with the device, as a possible complication.Should additional information is provided, a supplemental emdr will be submitted.This emdr documents information associated to the bard/davol xenmatrix ab graft, an additional emdr was submitted to document information associated to the bard/davol ventralight st hernia patch.The information provided by bard 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 bard.Remains implanted.

Event Description

It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma and wound dehiscence.On (b)(6) 2016 - the patient underwent exploratory laparotomy with ventral hernia repair with implant of bard/davol ventralight st hernia patch (this procedure was prior to the (b)(6) clinical study.) on (b)(6) 2016 - the patient underwent surgery for incision and drainage of abdominal wall abscess due to surgical site infection/abscess.On (b)(6) 2017 - the patient was implanted with the xenmatrix ab graft during a hernia repair procedure.The hernia site classification is noted as a class iii (contaminated).An intraperitoneal without component separation technique was performed.The defect measured 12 cm in length and 8 cm in width.The graft was trimmed and a 5 cm graft overlap was maintained around the hernia defect.This was a midline hernia located in the umbilical and infraumbilical area.A long-term absorbable monofilament suture was used with 15 fixation points.The previously implanted bard ventralight st hernia patch was explanted during this procedure.Two drains were inserted in the left lower quadrant and one in the right lower quadrant.On (b)(6) 2017 - subcutaneous drain placed in the right lower quadrant was removed.On (b)(6) 2017 - the patient was discharged from the hospital.On (b)(6) 2017 - retro-rectus drain placed in the left lower quadrant was removed.On (b)(6) 2017 - the patient was diagnosed with pneumonia and treated with intravenous "vanc/ctx" in emergency department and then transitioned to levofloxacin to be received orally for a total of 7 days on (b)(6) 2017 - the patient was discharged from hospital after being treated for pneumonia.On (b)(6) 2017 - subcutaneous drain placed in the left lower quadrant was removed.On (b)(6) 2017 - pink serous drainage was noted at the incision site.On (b)(6) 2017 the patient experienced a seroma and wound dehiscence.Two small openings with serous drainage and openings were packed, no action was taken with the study device, which remains in vivo.The adverse events of seroma and wound dehiscence are classified by the clinician as being possible related to the study device and definitely related to the procedure.The outcome is reported to be recovering / resolving.

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications (seroma, wound dehiscence) and any problem with the bard / davol xenmatrix ab graft used to treat the patient.As reported the graft was implanted into a contaminated environment and post implant the patient was hospitalized with pneumonia.The study subject is an elderly patient with a complicated medical / surgical history that includes, post operative infections, diabetes, obesity, and prior abdominal wall incisions / surgeries.The adverse events of seroma and wound dehiscence are classified by the study clinician as being possible related to the study device and definitely related to the procedure.The outcome is reported to be recovering / resolving, the graft remains implanted at this time.No definitive conclusion can be made at this time.Seroma formation is a known inherent risk of surgery and is listed in the instructions-for-use, which are provided with the device, as a possible complication.Should additional information is provided, a supplemental emdr will be submitted.This emdr documents information associated to the bard / davol xenmatrix ab graft, an additional emdr was submitted to document information associated to the bard / davol ventralight st hernia patch.This is an addendum to the initial emdr to document additional information provided.As reported, the subject patient, underwent exploration of the wound.The wound was then closed and it is reported that the incision was clear and healed.The adverse event of additional surgical intervention is classified by the clinician as being possibly related to the study device and definitely related to the procedure.This information does not change the initial determination, no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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 : remains implanted.

Event Description

It was reported to davol that a patient who is part of a clinical study experienced a post operative seroma and wound dehiscence.On (b)(6) 2016, the patient underwent exploratory laparotomy with ventral hernia repair with implant of bard / davol ventralight st hernia patch (this procedure was prior to the xenmatrix ab clinical study).On (b)(6) 2016, the patient underwent surgery for incision and drainage of abdominal wall abscess due to surgical site infection / abscess.On (b)(6) 2017, the patient was implanted with the xenmatrix ab graft during a hernia repair procedure.The hernia site classification is noted as a class iii (contaminated).An intraperitoneal without component separation technique was performed.The defect measured 12cm in length and 8cm in width.The graft was trimmed and a 5cm graft overlap was maintained around the hernia defect.This was a midline hernia located in the umbilical and infraumbilical area.A long-term absorbable monofilament suture was used with 15 fixation points.The previously implanted bard ventralight st hernia patch was explanted during this procedure.Two drains were inserted in the left lower quadrant and one in the right lower quadrant.On (b)(6) 2017, subcutaneous drain placed in the right lower quadrant was removed.On (b)(6) 2017, the patient was discharged from the hospital.On (b)(6) 2017, retro-rectus drain placed in the left lower quadrant was removed.On (b)(6) 2017, the patient was diagnosed with pneumonia and treated with intravenous "vanc/ctx" in emergency department and then transitioned to levofloxacin to be received orally for a total of 7 days.On (b)(6) 2017, the patient was discharged from hospital after being treated for pneumonia.On (b)(6) 2017, subcutaneous drain placed in the left lower quadrant was removed.On (b)(6) 2017, pink serous drainage was noted at the incision site.On (b)(6) 2017, the patient experienced a seroma and wound dehiscence.Two small openings with serous drainage and openings were packed, no action was taken with the study device, which remains in vivo.The adverse events of seroma and wound dehiscence are classified by the clinician as being possible related to the study device and definitely related to the procedure.The outcome is reported to be recovering / resolving.Addendum: on (b)(6) 2018, the subject: (b)(6) underwent exploration of the wound.The wound was then closed.On (b)(6) 2018, it is reported that the incision was clear and healed.The adverse event of additional surgical intervention is classified by the clinician as being possibly related to the study device and definitely related to the procedure.

• Brand Name: XENMATRIX AB
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7216409
• MDR Text Key: 98135434
• Report Number: 1213643-2018-00120
• Device Sequence Number: 1
• Product Code: PIJ
• UDI-Device Identifier: 00801741074295
• UDI-Public: (01)00801741074295
• Combination Product (y/n): N
• PMA/PMN Number: K151177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Catalogue Number: 1152020
• Device Lot Number: HUAY2190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 103