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

Catalog Number	1161935
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing review that included review of sterility records was performed and found that the lot was manufactured / sterilized to specification.The ifu for the xenmatrix graft was reviewed and states, "place device in maximum possible contact with healthy, well vascularized tissue to promote cell ingrowth and tissue remodeling." and "if an infection develops, it should be treated aggressively.¿ post surgical staph infection is a known inherent risk of any surgical procedure.Additionally, the investigation performed confirms that the graft provided was sterilized per procedure prior to distribution.Based on the events as reported, a definitive conclusion cannot be made at this time.Should additional information be provided, a supplemental mdr 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.
Event or Problem Description
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 eaten away by the infection.However, some pieces may have been removed during wound cleaning.It is reported that radiologist stated that the graft is no longer present in the body.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6438462
• Report Number: 1213643-2017-00191
• Device Sequence Number: 1102549
• Product Code: FTM
• UDI-Device Identifier: 00801741031441
• UDI-Public: (01)00801741031441(17)141228(10)HUWK0751
• Combination Product (Y/N): N
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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: 12/28/2014
• Device Catalogue Number: 1161935
• Device Lot Number: HUWK0751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/28/2017
• 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: 49 YR