MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX; PORCINE SURGICAL MESH

Catalog Number UNKAA081

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

Patient Problems Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusions can be made.Per medical records review, about 1 year 8 months post implant of xenmatrix, patient was diagnosed with hernia recurrence, bowel obstruction and adhesions thereby underwent repair.The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications.This emdr represents xenmatrix (device #2).An additional supplemental emdr was submitted to represent the mesh ¿ ventralex (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 : not returned.

Event Description

Addendum per additional information provided: on (b)(6) 2011 patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with implant of ventralex mesh (device #1).Per operative notes, ¿hernia sac was dissected free and the sac containing incarcerated omentum was separated.Following this, a ventralex mesh (device #1) was placed inside the abdominal cavity between the omentum and muscle.This was tacked and sutured.¿ on (b)(6) 2015 patient was diagnosed with recurrent incarcerated incisional hernia, small bowel obstruction and severe abdominal pain thereby underwent open repair with implant of xenmatrix (device #2) and removal of ventralex mesh (device #1).Per operative notes, ¿midline incision was made above the palpable incarcerated hernia to below the umbilicus.Extensive enterolysis was carried out freeing all the bowel loops from the adherent mesh for the previous incisional hernia repair.The previous mesh (device #1) was excised.The bowel repair was then carried out using xenmatrix (device #2).This was placed on both edges of the fascia in underlay fashion and secured.¿ on (b)(6) 2017 patient was diagnosed with recurrent incarcerated ventral incisional hernia thereby underwent open repair with implant of ventralex st (device #3).Per operative notes, ¿identified two distinct areas where herniation had occurred, one was above the umbilicus and one was just lateral to it on the left side.The sacs were opened and dissected.Took down all the adhesions of the small intestine and the old mesh graft (device #2) was found.Once this was done, fascial defect through which the hernias were both protruding was identified.Ventralex st (device #3) was secured to the underside of the old fascia on the underside old graft (device #2) with suture.¿ attorney alleges that the patient had adhesions, bowel obstruction, infection, pain and hernia recurrence.

• Brand Name: XENMATRIX
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: 18422804
• MDR Text Key: 331666521
• Report Number: 1213643-2023-095372
• 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: 12/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 103 KG