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

Catalog Number 1161020

Device Problems Device Expiration Issue (1216); Use of Device Problem (1670)

Patient Problems Unspecified Infection (1930); Peritonitis (2252)

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the user inadvertently implanted an expired graft that was provided to the user facility prior to the expiration date.Based on this information the root cause for the expired device being implanted is use related.Regarding the patient developing acute peritonitis the root cause is inconclusive.The surgeon who explanted the xenmatrix graft, was asked if the peritonitis was caused/contributed to by the graft that was used, he could not say either way, but he was not convinced that the graft was at fault as it was only days old.Due to the privacy laws of canada patient specific information was not provided.A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.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.Not returned.

Event Description

The following was reported to davol.On (b)(6) 2017 - the patient was implanted with a xenmatrix graft.Following surgery it was noted that the implanted graft had an expiry date of 01/31/2017 and had inadvertently been implanted seven days after the labeled expiry.It was reported that the patient had been made aware of this event, but no medical intervention was taken.On (b)(6) 2017 ¿ it was later reported that the patient had developed acute peritonitis and underwent an additional procedure.During this procedure the xenmatrix graft was explanted.The surgeon reports that he could not determine a definitive cause of the peritonitis that presented, however was not convinced that the graft was at fault for the development of the acute peritonitis.There was no connection made between the devices implanted after its labeled expiration period being the cause of the problem that presented.

Manufacturer Narrative

This is an addendum to the initial mdr to document additional information obtained through follow up activities with the surgeon.The surgeon indicated that the patient was an elderly woman with a history of complicated surgeries and reports there was no link between the xenmatrix graft and the complications experienced by the patient.Regarding infection the warning section of the ifu states, "if an infection develops it should be treated aggressively." additionally, the adverse reaction section lists infection as a potential complication.Due to the privacy laws of (b)(6), patient specific information was not provided.A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental mdr will be submitted.

Event Description

This is an addendum to the initial mdr to document additional information obtained through follow up activities with the surgeon.It was initially reported that the patient had developed acute peritonitis and underwent an additional procedure.Additional information provided indicates that the patient experienced a sudden pain and deep surgical site infection resulting in the further surgical intervention.The acute peritonitis had erupted as a result of this infection.The surgeon decided to remove the graft purely as a foreign body at the time of surgery.The surgeon reports that there was no link between the xenmatrix graft and the complications experienced by the patient.The surgeon also indicated that the patient was an elderly woman with a history of complicated surgeries.Patient has not suffered markedly from her surgery post removal of the graft and the patient is currently back to her baseline.

• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6384159
• MDR Text Key: 69254976
• Report Number: 1213643-2017-00156
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 1161020
• Device Lot Number: HUYK1415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2015
• 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