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

Catalog Number UNKAA081

Device Problem Material Disintegration (1177)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine the degree to which the xenmatrix graft may have caused or contributed to the reported wound dehiscence.The reason for the disintegration of the graft, would appear to be due to the use of a wound vac used to treat the wound dehiscence.The precautions section of the instructions-for-use states, "avoid drying of the implant through ¿continued suction devices¿ as this may negatively impact the performance of the implant." multiple attempts have been made requesting additional information, however we have not received a response.Photos provided show the progression of the wound for a 2.5 week period.However, do not assist in determining a root cause for the wound dehiscence.At this time, the results of this investigation are inconclusive.A lot number was not provided, without this information a review of the manufacturing records is not possible.Should additional information be obtained, 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.No sample.

Event Description

It was reported that a xenmatrix graft was placed in the patient as an overlay and following the case the fascia dehisced and left the graft exposed.The facility attempted to cover the exposed graft with a wound vac, while keeping it as moist as possible.After a couple of weeks the surgeon believed the graft was dissolving.A surgeon to surgeon consult was arranged and photos of the wound were provided to the consulting surgeon.As a result of this consult the surgeon was advised to switch to a wet-to-dry dressing, debride the graft and put a skin graft.

• Brand Name: XENMATRIX
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7703266
• MDR Text Key: 114459648
• Report Number: 1213643-2018-02443
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention