MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL; SURGICAL MESH

Catalog Number 0010205

Device Problems Defective Device (2588); Folded (2630); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)

Event Date 07/30/2012

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.It is alleged that the patient's mesh buckled, and folded, however, no sample has been returned for evaluation.Without the sample returned for evaluation the allegations can not be confirmed and the reason for them can not be determined.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.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.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2008 - the patient underwent a hernia repair using a composix kugel mesh.The attorney alleges that the composix kugel subsequently became somewhat deformed and significantly buckled in part of the abdominal cavity.It is alleged that the buckling and folding of the mesh resulted in the patient suffering severe physical and economic damages, including injury to her bowel and open surgery to remove the defective device.The attorney alleges that the patient was seriously and permanently injured.

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.It is alleged that the patient's mesh buckled, and folded, however, no sample has been returned for evaluation.Without the sample returned for evaluation the allegations can not be confirmed and the reason for them can not be determined.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this supplemental mdr is submitted to document additional information provided: the attorney alleges ring break and mesh migration, there is no indication in the medical records provided of ring break or migration of the mesh.Medical records indicate buckling and folding of the mesh.It is unclear based on medical record review what may have caused the mesh to buckle and fold.Based on the additional information received, no conclusions can be made.Recurrence and adhesions are known inherent risks of hernia repair surgery.The instructions-for-use (ifu) supplied with the device, identifies hernia recurrence and adhesions as possible complications.In regards to infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may have to be removed.An unresolved infection, however, may require removal of the prosthesis.".

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) /2008 - the patient underwent a hernia repair using a composix kugel mesh.The attorney alleges that the composix kugel subsequently became somewhat deformed and significantly buckled in part of the abdominal cavity.It is alleged that the buckling and folding of the mesh resulted in the patient suffering severe physical and economic damages, including injury to her bowel and open surgery to remove the defective device.The attorney alleges that the patient was seriously and permanently injured.Addendum per additional information provided: attorney alleges that the patient experienced abscess, adhesions, bowel perforation & removal, fistulae, infections, pain, hernia recurrence, mesh migration, mesh shrinkage, ring break, seroma, emotional injuries, and severe inflammatory responses.Per provided medical records: on (b)(6) 2008 - patient was diagnosed with large periumbilical ventral incisional hernia and underwent repair.Per the operative report, extensive adhesiolysis was required to free omental and intestinal adhesions to the hernia sac, abdominal wall and intraabdominal viscera.The redundant sac was excised and the fascial defect was sharply defined.Through the hernia defect, a medium bard/davol composix kugel mesh was placed.The mesh was circumferentially sutured due to the full thickness of the abdominal wall with prolene sutures.On (b)(6) 2012 - patient was diagnosed with an incarcerated/strangulated ventral incisional hernia, probable abdominal wall abscess and underwent surgery for mesh explant.Per the operative report, the patient had a large firm mass in the epigastric midline region.The abscess was unroofed, there was whitish, tan purulent fluid bathing the previously placed composix kugel mesh.At this point, it was clear that the mesh had to be removed.Per the surgeon, the etiology of the infection this far remote from mesh placement procedure was unclear; it was conceivable that the patient had an undrained sizable seroma anterior to the mesh that ultimately became superinfected.Mesh removal procedure was started from the left side.The unincorporated parts were carefully peeled from the abdominal wall, but polypropylene aspect of the mesh was well incorporated into the abdominal wall.Additionally, there was some buckling and folding of the mesh with polypropylene exposed to the viscera.The surgeon sharply dissected the mesh from the abdominal wall and residual omentum; the small bowel was loosely adherent to the ptfe aspect of the mesh and the adhesions were lysed.The ptfe aspect of the mesh did have some yellowish discoloration, but there was no evidence of enteric content or fistula.The mesh was ultimately detached and removed completely.Further adhesiolysis was performed circumferentially around the wound.Primary closure was not feasible and given the infected circumstances, wound vac was placed and a non-bard/davol permacol was placed in a bridging fashion.On (b)(6) 2012 - patient underwent laparotomy, lysis of adhesions and small bowel resection.Per the operative details, greenish-brown drainage in wound vac was noted, significant amounts had been evacuated, the findings were consistent with either an enterotomy or fistula.The previously placed biologic mesh (permacol) was removed.There was disruption of the small bowel, adherent to the abdominal wall with findings consistent with erosion of the previously placed mesh (ck) into a loop of small bowel, resulting in the infection of the mesh and the abscess noted at the first operation.After extensive lysis of adhesions, a segment of small bowel was resected.Primary fascial closure with wound vac placement.

• Brand Name: MESH - COMPOSIX KUGEL
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6743491
• MDR Text Key: 81009445
• Report Number: 1213643-2017-00452
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061314
• 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,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Catalogue Number: 0010205
• Device Lot Number: HURI0378
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2007
• 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): Disability; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 75 KG