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

Catalog Number 1152025

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Bacterial Infection (1735); Hernia (2240)

Event Date 11/19/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the events as alleged.The patient is an obese male, who 7 months post implant, developed wound issues with subsequent wound infection.The patient was treated in the hospital and released, the graft remains implanted.The adverse event of infection was assessed as possibly related to the study device and possibly related to the procedure.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(4) 2016.Regarding infection the warning section of the instructions-for-use states, "this device is not indicated for the treatment of infection.If an infection develops, treat the infection aggressively." a review of the manufacturing records was performed and found that the lot was manufactured to specification.All process steps were completed per manufacturing procedures, inspection procedures, as documented in work order and lot history records.Product passed all required inspections at both end product and subassembly levels.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.If additional information is provided, a supplemental emdr will be submitted.Note: 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 wound infection.On (b)(6) 2017 the subject patient underwent repair of large ventral hernia using the xenmatrix ab graft.The hernia site wound has been assessed as a class 1 (clean) site.A retro-rectus with component separation technique was performed.The graft was not trimmed and a 5cm graft overlap was maintained around the hernia defect.Absorbable monofilament suture was used to fixate the graft.The midline fascia and skin were fully closed.Four drains were inserted with two placed between the subcutaneous tissue and anterior fascia and the other two were placed over the mesh and underneath the fascia closure.On (b)(6) 2017 all drains were removed.On (b)(6) 2017 upon physical exam, the subject patient was noted to have "two areas of wound opening.On (b)(6) 2017 the subject patient was administered antibiotics for skin lesion and deep incisional wound infection/abscess.The patient underwent reoperation for aspiration and deep tissue cultures.Cultures revealed a bacterial infection of streptococcus pygenes.On (b)(6) 2017 the subject patient was discharged from the hospital.On (b)(6) 2017 the subject patient presented for post operative follow up visit.As reported, "skin over site is clean.Abdomen skin is clean/dry.Wound right upper quadrant was clean.Wound right lower quadrant clean." these events (skin lesion / infection /abscess) were assessed by the clinician as possibly related to the study device and possibly related to the procedure.

Manufacturer Narrative

This is an addendum to the initial emdr to document additional information provided via the clinical project manager.The initial report regarding the postoperative incisional wound infection/abscess was updated to not related to the study device.The hernia recurrence was updated to possibly related to the study device and possibly related to the procedure.The information provided indicates that surgical intervention is necessary, however has not been scheduled.Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the hernia recurrence.The patient is an obese male, who 7 months post implant, developed wound issues with subsequent wound infection.There is no way of knowing at this time how the postoperative wound issues may have contributed to the development of a hernia recurrence.To date this is the only reported complaint for this manufacturing lot of 41 units released for distribution in august, 2016.Recurrence is a known inherent risk of hernia repair surgery.Regarding recurrence the warning section of the instructions-for-use states, "to minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides." a review of the manufacturing records was performed and found that the lot was manufactured to specification.All process steps were completed per manufacturing procedures, inspection procedures, as documented in workorder and lot history records.Product passed all required inspections at both end product and subassembly levels.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.If additional information is provided, a supplemental emdr will be submitted.

Event Description

As initially reported on (b)(6) 2018: it was reported to davol that a patient who is part of a clinical study experienced a post operative wound infection.On (b)(6) 2017 the subject patient underwent repair of large ventral hernia using the xenmatrix ab graft.The hernia site wound has been assessed as a class 1 (clean) site.A retro-rectus with component separation technique was performed.The graft was not trimmed and a 5cm graft overlap was maintained around the hernia defect.Absorbable monofilament suture was used to fixate the graft.The midline fascia and skin were fully closed.Four drains were inserted with two placed between the subcutaneous tissue and anterior fascia and the other two were placed over the mesh and underneath the fascia closure.On (b)(6) 2017 all drains were removed.On (b)(6) 2017 upon physical exam, the subject patient was noted to have "two areas of wound opening.On (b)(6) 2017 the subject patient was administered antibiotics for skin lesion and deep incisional wound infection/abscess.The patient underwent reoperation for aspiration and deep tissue cultures.Cultures revealed a bacterial infection of streptococcus pygenes.On (b)(6) 2017 the subject patient was discharged from the hospital.On (b)(6) 2017 the subject patient presented for post operative follow up visit.As reported, "skin over site is clean.Abdomen skin is clean/dry.Wound right upper quadrant was clean.Wound right lower quadrant clean." these events (skin lesion / infection /abscess) were assessed by the clinician as possibly related to the study device and possibly related to the procedure.Addendum: it was initially reported that postoperative, the patient developed an incisional wound infection/abscess and at that time was assessed by the clinician as possibly related to the study device.The incisional wound infection/abscess has been reassessed by the clinician as not related to the study device and possible related to the procedure.On (b)(6) 2017 the patient was diagnosed with a hernia recurrence and at that time the recurrence was assessed by the clinician as not related to the study device.The recurrence has been reassessed by the clinician as moderate in severity, possibly related to the study device and possibly related to the procedure.The information provided indicates that surgical intervention is necessary, however has not been scheduled.

Event Description

It was reported to davol that a patient who is part of a clinical study experienced a post operative wound infection.On (b)(6) 2017 the subject patient underwent repair of large ventral hernia using the xenmatrix ab graft.The hernia site wound has been assessed as a class 1 (clean) site.A retro-rectus with component separation technique was performed.The graft was not trimmed and a 5cm graft overlap was maintained around the hernia defect.Absorbable monofilament suture was used to fixate the graft.The midline fascia and skin were fully closed.Four drains were inserted with two placed between the subcutaneous tissue and anterior fascia and the other two were placed over the mesh and underneath the fascia closure.On (b)(6) 2017 all drains were removed.On (b)(6) 2017 upon physical exam, the subject patient was noted to have "two areas of wound opening.On (b)(6) 2017 the subject patient was administered antibiotics for skin lesion and deep incisional wound infection/abscess.The patient underwent reoperation for aspiration and deep tissue cultures.Cultures revealed a bacterial infection of streptococcus pygenes.On (b)(6) 2017 the subject patient was discharged from the hospital.On (b)(6) 2017 the subject patient presented for post operative follow up visit.As reported, "skin over site is clean.Abdomen skin is clean/dry.Wound right upper quadrant was clean.Wound right lower quadrant clean." these events (skin lesion / infection /abscess) were assessed by the clinician as possibly related to the study device and possibly related to the procedure.Addendum: it was initially reported that postoperative, the patient developed an incisional wound infection/abscess and at that time was assessed by the clinician as possibly related to the study device.The incisional wound infection/abscess has been reassessed by the clinician as not related to the study device and possible related to the procedure.On (b)(6) 2017 the patient was diagnosed with a hernia recurrence and at that time the recurrence was assessed by the clinician as not related to the study device.The recurrence has been reassessed by the clinician as moderate in severity, possibly related to the study device and possibly related to the procedure.The information provided indicates that surgical intervention is necessary, however has not been scheduled.Addendum: the subject patient was diagnosed with an abdominal hernia on (b)(6) 2017 and underwent additional surgical intervention in relation to this hernia on (b)(6) 2017.

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the events as alleged.The patient is an obese male, who 7 months post implant, developed wound issues with subsequent wound infection.The patient was treated in the hospital and released, the graft remains implanted.The adverse event of infection was assessed as possibly related to the study device and possibly related to the procedure.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august, 2016.Regarding infection the warning section of the instructions-for-use states, "this device is not indicated for the treatment of infection.If an infection develops, treat the infection aggressively." a review of the manufacturing records was performed and found that the lot was manufactured to specification.All process steps were completed per manufacturing procedures, inspection procedures, as documented in work order and lot history records.Product passed all required inspections at both end product and subassembly levels.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.This is an addendum to the initial emdr to document additional information provided via the clinical project manager.The initial report regarding the postoperative incisional wound infection/abscess was updated to not related to the study device.The hernia recurrence was updated to possibly related to the study device and possibly related to the procedure.The information provided indicates that surgical intervention is necessary, however has not been scheduled.Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the hernia recurrence.The patient is an obese male, who 7 months post implant, developed wound issues with subsequent wound infection.There is no way of knowing at this time how the postoperative wound issues may have contributed to the development of a hernia recurrence.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august, 2016.Recurrence is a known inherent risk of hernia repair surgery.Regarding recurrence the warning section of the instructions-for-use states, "to minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides." a review of the manufacturing records was performed and found that the lot was manufactured to specification.All process steps were completed per manufacturing procedures, inspection procedures, as documented in work order and lot history records.Product passed all required inspections at both end product and subassembly levels.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.If additional information is provided, a supplemental emdr will be submitted.H11: this is an addendum to the previously submitted emdrs to document that on (b)(6) 2017 the patient underwent a revision procedure to address the recurrent hernia.No additional information was provided, there is no change to the initial determination, no conclusion can be made.Update fields: b4, b5, b7, g4, g7, h2, h6, h11.Corrected field: b3.Note: section a through f - 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.

• 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: 7438103
• MDR Text Key: 105728035
• Report Number: 1213643-2018-01108
• Device Sequence Number: 1
• Product Code: PIJ
• UDI-Device Identifier: 00801741074288
• UDI-Public: (01)00801741074288
• 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,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 1152025
• Device Lot Number: HUAT2142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 103