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

Catalog Number 1152025

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent the xenmatrix ab may have caused or contributed to the patient's partial bowel obstruction.The patient has a complicated medical history which includes, multiple small bowel obstructions and multiple abdominal surgeries.At this time no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be obtained, a supplemental emdr will be submitted.Note, emdr's were previously submitted to document the other reported adverse events associated to this patient.Note: 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

The following was reported and is associated with a clinical study.On (b)(6) 2016 at the time of implant the hernia site wound was classified as a class 1 (clean) with no existing infection.The index procedure included a partial mesh (unknown) excision and extensive lysis of adhesions.The unknown mesh was removed due to the extent of the adhesions.The existing hernia repair was performed with a retro-rectus technique without component separation.The hernia defect was measured with a length of 25cm and width of 14cm.The xenmatrix ab graft was trimmed prior to placement.There was a graft overlap of at least 5cm around the hernia defect.The hernia location is listed to have encompassed the subxiphoid, epigastric, umbilical and infraumbilical area.The graft was suture fixated.A surgical drain was placed in the right lower quadrant, recto-rectus space.Following the implant procedure during the time period of (b)(6) 2016 - (b)(6) 2016 the patient was treated for multiple adverse events (dehydration, seroma, abdominal pain, diarrhea) these events have resolved.The patient was hospitalized (b)(6) 2018-(b)(6) 2018 and diagnosed with ileal diverticulitis.This event was assessed as not related to the study device and not related to the procedure.As reported this event has resolved.The patient was hospitalized on (b)(6) 2018-(b)(6) 2018, diagnosed with a partial bowel obstruction.This event has been assessed as possibly device related and possibly procedure related.The patient was treated with a nasogastric tube and gastrografin and the event resolved.

• 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: 7626759
• MDR Text Key: 111944273
• Report Number: 1213643-2018-02099
• Device Sequence Number: 1
• Product Code: PIJ
• UDI-Device Identifier: 00801741074288
• UDI-Public: (01)00801741074288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Catalogue Number: 1152025
• Device Lot Number: HUZL0467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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 Weight: 64