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

Catalog Number 1151015

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any, the xenmatrix ab graft may have caused or contributed to the abdominal pain and diarrhea.This is a patient with a complicated medical / surgical history which includes laparoscopic colectomy, lysis of adhesions, rigid sigmoidoscopy and ileorectal anastomosis, colectomy and ileorectal anastomosis, and a loop ileostomy takedown and primary small bowel anastomosis, in the area of the repair.The clinician has assessed this adverse event as possibly related to the study device and possibly related to procedure.It is also possible that the adverse event is related to a patient comorbidity and not the study device.No action was taken with the study device and the adverse event is reported to have resolved.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be reported, a supplemental emdr 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.Remains implanted.

Event Description

It was reported that a patient who is part of a clinical study had experienced pain and diarrhea.On (b)(6) 2017 - the patient underwent a primary incisional infraumbilical hernia repair with implant of the xenmatrix ab graft.Intraperitoneal without component separation technique was used.The xenmatrix ab graft was not trimmed and a 5mm graft overlap was maintained around the hernia defect.On (b)(6) 2018 - the patient was assessed to have a clear and clean incision, no erythema and no recurrent hernia.On (b)(6) 2018 - the patient was assessed to have a well healed incision and no evidence of a hernia.On (b)(6) 2018 - the patient was hospitalized for abdominal pain and diarrhea.She was given iv fluids and pain medication.On (b)(6) 2018 - the patient was discharged with a status of recovered / resolved.This event has been assessed by the clinician as severe, possibly related to the study device and possibly related to be implant procedure.

• Brand Name: XENMATRIX AB
• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7793820
• MDR Text Key: 117562544
• Report Number: 1213643-2018-02811
• Device Sequence Number: 1
• Product Code: PIJ
• UDI-Device Identifier: 00801741074226
• UDI-Public: (01)00801741074226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 1151015
• Device Lot Number: HUBR0416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73