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

Catalog Number 1161935

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930)

Event Date 01/06/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusions can be made.Per medical records review, about 2 months post implant of xenmatrix, patient was diagnosed with abdominal pain and infection thereby underwent repair.The instructions-for-use supplied with the device list infection as a possible complication.In regard to infection, the warnings section in ifu states, "if an infection develops, it should be treated aggressively.An allergic reaction, which is unrelated to other therapy, is an indication to consider removal of xenmatrix surgical graft." this emdr represents xenmatrix (device #2).An additional supplemental emdr was submitted to represent bard flat mesh (device #1).Note: section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

Event Description

Per information provided by patient's attorney: (b)(6) 2003 - patient was diagnosed with ventral incisional hernia thereby underwent repair with implant of bard flat mesh (device #1).(note: there was no operative notes provided).(b)(6) 2015 - patient was diagnosed with severe abdominal pain, sepsis, recurrent incisional hernia with equivocal findings of strangulation and perforation thereby underwent exploratory laparotomy with explant of bard flat mesh (device #1) and transverse colectomy.Per operative notes, ¿the old mesh (device #1) underlying hernia sac containing incarcerated, strangulated colon was encountered.The hernia sac was complex containing omentum and a loop of necrotic transverse colon.The fascial defect was enlarged superiorly and inferiorly to achieve reduction.Extensive lysis of adhesions was performed and a large subacute/chronic abscess cavity was encountered.The old mesh (device #1) was removed in its entirety.A diverting loop ileostomy was then created in the right lower quadrant.¿ (b)(6) 2015 - patient was diagnosed with perforated afferent limb of loop ileostomy at the fascial level thereby underwent repair.(b)(6) 2016 - patient visited hospital for loop ileostomy closure.(b)(6) 2016 - patient was diagnosed with parastomal hernia thereby underwent open repair with placement of xenmatrix (device #2).Per operative notes, ¿the hernia defect was found in the plane between the scar tissue and the intestines, adhesions were lysed and the loop of bowel was freed up.There was a parastomal hernia and there was dense inflammation noted in the right side of the abdomen.There was purulent necrotic material.A piece of xenmatrix (device #2) was placed over the fascia.¿ (b)(6) 2016 to (b)(6) 2017 - patient had multiple hospital visits for minimal abdominal pain and infection thereby treated with antibiotics.Attorney alleges that the patient had abscess, adhesions, infections, bowel obstruction, bowel perforation, hernia recurrence, pain and emotional injuries.It was also alleged that the patient had removal surgery, abdominal washout, ileostomy revision and vac placement.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 18746912
• MDR Text Key: 335867078
• Report Number: 1213643-2024-090778
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: 1161935
• Device Lot Number: HUZL0993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 121 KG