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

Catalog Number 1161520

Device Problem Insufficient Information (3190)

Patient Problems Anaphylactic Shock (1703); Reaction (2414)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

The surgeon provided information about the patient who had a complex medical history, whose condition was compromised at the time of surgery and was not in good health.The doctor reported the patient had no known allergy to porcine.The ifu states "an allergic reaction, which is unrelated to other therapy, is an indication to consider removal of the xenmatrix surgical graft." the infection that presented after the implant was not associated to the use of the product.However, regarding infection the ifu warns "if an infection develops, it should be aggressively treated." patient has a complex medical history and there is no connection that can be made at this time between the post-op complications experienced and the use of xenmatrix to treat the wound.At this time no conclusions can be made.If additional information is obtained, a supplemental mdr will be submitted.Four additional mdr's are filed to document the other xenmatrix grafts implanted on (b)(6) 2016.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 Description

It was reported that a patient who was treated with xenmatrix experienced an anaphylactic shock type response after implant.The patient who had been hospitalized for an extended period of time with a non-healing wound was brought to the or to have the abdominal wound bridged.This was a very large area 70cm x 60cm and the surgeon used five pieces of xenmatrix graft and a wound vac was placed.It was reported the patient experienced a large bowel movement and fibrillation when moving from the or and required resuscitation.The patient was stabilized.Within 24 hours patient mounted a wbc count of >30 with a large bandemia, he developed v-fib and received aicd shock.It was reported that a post operative infection was present.Patient had erosion and breakdown of the previously placed feeding jejunostomy.Patient was returned to or for washout, removal of jejunostomy, additional mesh fixation and wound vac therapy.Treatment included the removal of an eroded section of xenmatrix graft material.The xenmatrix grafts were left implanted.The surgeon could not confirm the cause of the post op events.This was reported to be her first use of xenmatrix and she had concern that the large about of graft used to bridge the defect could have contributed to the problem.She indicated that he had no other reactive type response to the material.

• 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: 5410200
• MDR Text Key: 37462459
• Report Number: 1213643-2016-00043
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 1161520
• Device Lot Number: HUYH0174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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): Hospitalization; Life Threatening; Required Intervention