MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX

Catalog Number 1161015

Device Problems Migration or Expulsion of Device (1395); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Complaint, Ill-Defined (2331); Prolapse (2475)

Event Date 04/30/2015

Event Type  Injury  

Event Description

The following allegation was reported to davol by the patient: the patient has alleged that in 2010 she underwent the removal of approximately six inches of intestine to relieve constant constipation and reduce rectal prolapse.Patient states the prolapse was reduced by securing the colon and strengthening the pelvic floor with the use of stitches.The patient alleges that she again prolapsed and on (b)(6) 2012 she was implanted with a bard xenmatrix graft during a post menopausal hysterectomy, oopherectomy and laparoscopic rectopexy repair procedure.The patient alleges that in (b)(6) 2015, she began noticing a bulge in the rectal area and feeling extreme pain.On (b)(6) 2015, the patient alleges that she underwent a surgical procedure for removal of appendix, which has been determined to be the cause of her extreme pain.She alleges that during this procedure, the xenmatrix graft was also removed due to recurrent prolapse.The patient reports that her physician noted extreme inflammation and poor incorporation of the graft.

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Medical records have not been provided and based on the patient's reported medical/surgical history and that "poor incorporation of the graft" was noted upon explant currently it is unknown whether the graft was implanted into healthy well-vascularized tissue.The ifu states "place device in maximum possible contact with healthy, well-vascularized tissue to promote ingrowth and tissue remodeling".Additionally, recurrent and inflammation are both identified in the adverse action section of ifu as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional information is obtained, a follow up mdr will be submitted.Note: section a through d - 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 to unwilling to provide any further patient, product, or procedural details to bart.

Manufacturer Narrative

This is an addendum to the initial mdr.The information provided in the maude event report was somewhat different than the information that was stated by the patient to davol and then documented in the initial mdr.Therefore, this supplemental mdr is sent to document the information obtained from the maude event report.No conclusion can be made.Based on the information reported the patient prolapsed again.Patient indicates that the device used did not incorporate.If additional information is provided a supplement mdr will be submitted.

Event Description

The following is an addendum to the initial mdr and reported to davol via maude event report (mw5042586): "i had pigskin mesh put in for rectal prolapse.It was attached from my stomach to my rectum.Immediately after the mesh was inserted i started to have problems.My ob/gyn doctor could feel the mesh and see that it was not attached where it should be.I was having pain in my hips and numbness that went down my leg.I was also unable to work.I saw 7 different doctors and it took 1 1/2 years before they decided to take the mesh out.The operating doctor said the mesh never attached, it floated around and tried to attach to my appendix, therefore, i had to remove my appendix also.".

• Brand Name: XENMATRIX
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 4827904
• MDR Text Key: 5901096
• Report Number: 1213643-2015-00187
• 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: Consumer,consumer,other
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 1161015
• Device Lot Number: HUVEBLO2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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: 50 YR