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

Catalog Number UNKAA066

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930)

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

The medical records indicate that this is a patient with multiple comorbidities including, obesity, hypertension, hyperlipidemia, tobacco use, coronary artery disease, heart attack, prostate cancer and peripheral arterial disease.The contact has provided davol with pictures of the patient and the patient's wound.Images show a progression of the wound opening in the abdominal region, exposed mesh and what appears to be a contaminated wound.The medical records indicate that the patient underwent multiple surgeries and it is unknown to which surgery / surgeries the pictures are associated with, nor would we be able to make an conclusions regarding the cause of the patients alleged outcome by reviewing the pictures.The patient was treated for adhesions and infection.Adhesion is listed in the adverse reaction section of the ifu as a possible complication.Regarding infection the warning section states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection, however, may require removal of the prosthesis." the medical records did not include a lot number therefore a review of the manufacturing records is not possible.Based on the medical records provided and the patient's multiple comorbidities at this time, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome.If additional information is provided, a supplemental mdr will be submitted.This mdr represents the "large" sepramesh implanted on (b)(6) 2011.A separate mdr was sent to document the "marlex" mesh implanted on (b)(6) 2008.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.

Event Description

The following is based on medical records provided by the patient's wife: on (b)(6) 2008 - repair of ventral epigastric incisional hernia.The operative report states, "adhesions bilat were freed, a piece of "marlex" mesh was brought to the field and sutured inside of the abdominal wall to keep the "marlex" mesh below the fascia" on (b)(6) 2009 - diagnosed with an "easily reducible" ventral incision hernia.Patient did not want surgery and was recommended to wear an abdominal binder.On (b)(6) 2010 - repair of recurrent ventral incisional hernia with the implant of an unknown "polypropylene" mesh.The "marlex" mesh had pulled loose on the right side and was removed.On (b)(6) 2011 - diagnosed with incision hernia with obstruction.Multiple hernia sites with possible incarceration.On (b)(6) 2011 - repair of two incarcerated recurrent incisional hernias.One located in the right lower quadrant which was repaired with two pieces of sepramesh and one in the left upper quadrant which was repaired with a "large" piece of sepramesh.A non-bard fixation device was used to reattach the previously placed mesh.On (b)(6) 2011 - postoperatively the patient was confused and disoriented, a ct scan showed some acute/subacute right posterior cerebral artery stroke.(b)(6) 2011 - follow up for hernia repair, no pain, nausea, or vomiting.Incisions were well healed.Patient works with physical and occupational therapy for hypertension related stroke.On (b)(6) 2014 - incision and drainage and removal (as much as possible) of infected "polypropylene" mesh.There appeared to be a portion of the "polypropylene" mesh which had created a hole in the small bowel proximally.The enterotomy was closed.The sepramesh was noted to be fully incorporated with no indication of explant.On (b)(6) 2015 - exploratory laparotomy with the explant of the infected "large" sepramesh previously implanted into the left upper quandrant.It appeared that the mesh had eroded into the small intestine in multiple areas and 3 separate bowel resections were performed.There were also tacks and sutures within the intestine.Mesh was also found to be attached to the left hepatic lobe of the liver.A small laceration was made during removal.On (b)(6) 2015 - abdominal reexploration, component separation and stoppa incisional hernia repair with a non bard/davol mesh.

• Brand Name: SEPRAMESH IP
• Type of Device: 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5270289
• MDR Text Key: 32766303
• Report Number: 1213643-2015-00415
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K053066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/13/2015
• 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; Disability
• Patient Age: 61 YR
• Patient Weight: 91