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

Catalog Number	1151015
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Diarrhea (1811)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7793820
• Report Number: 1213643-2018-02811
• Device Sequence Number: 1143297
• Product Code: PIJ
• UDI-Device Identifier: 00801741074226
• UDI-Public: (01)00801741074226
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 1151015
• Device Lot Number: HUBR0416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73