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

Catalog Number 1161015

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Unspecified Infection (1930)

Event Date 05/07/2015

Event Type  Injury  

Event Description

The following is based on medical record review: implant of a bard/davol xenmatrix graft (mesh #1) for repair of an incisional hernia developed following previous weight loss surgery.(no operative report provided) implant of an unknown synthetic mesh for repair of a peri umbilical hernia.(not operative report provided) (b)(6) 2014 - implant of a bard phasix mesh (mesh #2) for repair of a recurrent upper midline incisional hernia and excisional debridement of foreign body suture granulomatous abdominal wall abscess tissue.(b)(6) 2015 - due to an abdominal wall infection the patient underwent the explant of the bard/davol xenmatrix graft, the unknown synthetic mesh and the bard/davol phasix mesh.Operative details note "the phasix mesh specifically was not incorporated into the abdominal wall." the abdominal wall infection was noted to be most likely related to the previously placed unknown synthetic mesh implant.

Manufacturer Narrative

Based on medical record review it appears that the abdominal wall infection can be associated to the unknown synthetic mesh.The explant operative report notes the abdominal wall infection was most likely related to the previously placed unknown synthetic mesh implant.Regarding infection the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the removal of the mesh.An unresolved infection may require removal of the device." without a lot number a review of the manufacturing records could not be conducted.At this time, a definitive conclusion cannot be made as to the degree to which the implanted graft may have caused or contributed to the patient's abdominal wall infection.If additional information is obtained, a follow up mdr will be submitted.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.This mdr represents the xenmatrix graft (mesh #1) implanted on an unknown date.A separate mdr was sent to document phasix mesh (mesh #2) implanted on (b)(6) 2014.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 4949480
• MDR Text Key: 16850859
• Report Number: 1213643-2015-00261
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K081272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1161015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 61 YR