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

Model Number 5959812

Device Problems Defective Device (2588); Folded (2630); Material Deformation (2976)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Unspecified Infection (1930); Hernia (2240); Disability (2371)

Event Date 05/08/2012

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided alleges the patient experienced pain, inflammation, adhesions, abscess and infection.While there is no indication that the adhesions were directly related to the sepramesh, adhesions and inflammation are both listed as known possible adverse reactions in the instructions-for-use.In regards to the allegation of infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ with the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2008 - the patient underwent surgery for repair of an incisional hernia.A sepramesh ip mesh was implanted to repair the hernia defect.On (b)(6) 2012 - it was alleged that the device subsequently folded over, became entwined with his bowel, caused a severe inflammatory response, infection and abscess.Among other treatment, the patient underwent additional surgery to remove the malfunctioning device, take down adhesions and evacuate the abscess associated with the device.The attorney alleges the patient was injured severely and permanently and has suffered and will continue to suffer physical pain.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2008 - the patient underwent surgery for repair of an incisional hernia.A sepramesh ip mesh was implanted to repair the hernia defect.(b)(6) 2012 - it was alleged that the device subsequently folded over, became entwined with his bowel, caused a severe inflammatory response, infection and abscess.Among other treatment, the patient underwent additional surgery to remove the malfunctioning device, take down adhesions and evacuate the abscess associated with the device.The attorney alleges the patient was injured severely and permanently and has suffered and will continue to suffer physical pain.Addendum per patient medical records: (b)(6) 2008 - a 53-year male patient, diagnosed with abdominal wall incisional hernias x4 and underwent extensive lysis of adhesions and repair with implant of a bard/davol sepramesh ip on (b)(6) 2008.Per the implant operative report details, ¿a large defect was noted in the left mid quadrant at the ostomy site.Multiple midline incisional hernias were encountered with the largest one being in the upper abdomen.The hernia sac was excised and numerous dense adhesions at the anterior abdominal wall were taken down.A large defect was noted in the left mid quadrant at the ostomy site.A 8 x 12 piece of bard/davol sepramesh ip mesh was then introduced into the abdominal cavity and stay sutures of 0 vicryl being placed superiorly, inferiorly, and mid portion of the mesh bilat.The superior portion of the 12-inch section was brought out through the skin at the level of the xiphoid using the endoclose and the inferior portion was brought out in the suprapubic area.The left mid portion of the stay suture was brought out in the left mid quadrant well passed the ostomy site.As was the right mid stay suture of the mesh.This was brought out lateral to the hernia site in the right lower quadrant at the ostomy site giving excellent overlap.¿ the sepramesh ip was also fixated using an unspecified autosuture tacking device placing ¿tacks 1 cm circumferentially around the edge of the mesh.¿ (b)(6) 2011 - about 3 years later, the patient experienced pain over the left side of the abdomen with fever.There was presence of localized abscess which was drained.The specimen was examined and found to be positive for mrsa.The patient was treated with bactrim.The patient had recurrent episodes of abdominal wall abscesses that were drained percutaneously.Cultures from the previous drainages had mrsa growth.Patient has been temporized with drainage, but never cleared of the infection.(b)(6) 2012 - the patient presented to the emergency department with fever (102°), tachycardia, cellulitis, and tenderness in the abdomen.An abdominal/pelvis ct scan revealed a rim enhanced fluid collection within the left abdominal wall between the mesh (sepramesh ip) and the abdominal wall in the site of previous abscess collection.(b)(6) 2012 - the patient underwent a laparoscopic repair of recurrent incisional hernia, lysis of adhesions, debridement of posterior rectus sheath from abdominal wall and removal of the mesh.Per the operative report details, ¿there were multiple loops of small bowel adherent to the anterior abdominal wall.There was a visible synthetic mesh (sepramesh ip) attached to the anterior abdominal wall, and there were visible spiral tacks seen within the mesh.Adhesiolysis was taken down into the pelvis and into the lower left abdomen.Adhesiolysis was focused in the left upper quadrant.The mesh (sepramesh ip) appeared to be redundant and folded in this area and was hanging down into the abdominal cavity.Eventually, all adhesions were lysed¿.¿upon removing the final adhesions from the mesh in the left mid abdomen, an abscess cavity was encountered.It appeared to be completely enclosed on 3 sides by redundant, folded mesh, and the base of the cavity was made up of loops of small bowel and the transverse colon.Once these adhesions were removed, a large amount of pus was expressed.It appeared to be just purulent material, with no signs of any succus to indicate a communication with the bowel.The purulent material was aspirated.A culture of this material was sent for anaerobic and aerobic culture.As much of the material was aspirated as possible to prevent spread of the infection throughout the abdominal cavity.¿ upon examining the transverse colon, a 2.5 cm irregular, white, hard nodule was identified in the omentum.This was excised out with a harmonic scalpel and sent to pathology as omental mass.¿ the mesh (sepramesh ip) was debrided from the abdominal wall, including debridement of the posterior rectus sheath.Starting at the area of the folded mesh, the entire infolding of the mesh that formed the cavity was excised out circumferentially with scissors and then peeled off the abdominal wall.Once this section of the mesh was completely cleared from the abdominal wall, it was inserted in an endocatch bag and removed through the right upper quadrant trocar site.¿ the remainder of the abdominal wall was removed in 3 further segments; a small abscess cavity was found within the fibers of the rectus muscle in the left mid abdomen and that was drained simultaneously.There was a ventral hernia (10 cm x 2 cm) identified in the midline which was appeared to have a hernia sac into the subcutaneous tissue.A piece of non- bard/davol (strattice biologic) mesh was implanted and fixated using a non-bard/davol fixation device (protacker).

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided alleges the patient experienced pain, inflammation, adhesions, abscess and infection.While there is no indication that the adhesions were directly related to the sepramesh, adhesions and inflammation are both listed as known possible adverse reactions in the instructions-for-use.In regards to the allegation of infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ with the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: h.11: this is an addendum to the initial mdr submitted.This supplemental emdr is submitted to report the additional event information received in the medical records received and to correct the udi no.As reported, the patient experienced pain, infection, adhesions, abscess, hernia recurrence and bowel injury post implant and underwent explant of the of the sepramesh ip.There are no medical records provided beyond this time, therefore the patient¿s clinical course is unclear.The explanted mesh was not returned to the manufacturer for evaluation.Based on the medical records received, there is no way to determine whether the bard/davol sepramesh ip mesh may have caused or contributed to the problems experienced based on the information provided and the patient¿s history of multiple abdominal surgical procedures.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - 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.H3 other text : device not returned.

• 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
• MDR Report Key: 6956394
• MDR Text Key: 89567186
• Report Number: 1213643-2017-00690
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(10)WBSAS014
• Combination Product (y/n): N
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2009
• Device Model Number: 5959812
• Device Catalogue Number: 5959812
• Device Lot Number: WBSAS014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 57 YR