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

Catalog Number	5954610
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Sepsis (2067); Hernia (2240); Obstruction/Occlusion (2422); Bowel Perforation (2668); Drug Resistant Bacterial Infection (4553)
Date of Event	12/14/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2015 - patient was diagnosed with incisional hernia and underwent open repair with the implant of ventralex st mesh.Per operative notes, "small bowel adhesions to the hernia sac were dissected off and the bowel was returned back into the peritoneal cavity.A ventralex st (device #1) was introduced into the peritoneal cavity and sutured the patch to overlying anterior abdominal wall fascia through the retention straps of the patch".(b)(6) 2015 and (b)(6) 2015 - patient was diagnosed with abdominal pain, distention, intestinal perforation, recurrent incarcerated incisional hernia with small bowel obstruction and abdominal wall mass.(b)(6) 2015 - patient was diagnosed with swiss cheese recurrent incisional hernia and underwent enterolysis, laparoscopic repair with the explant of ventralex st mesh and implanted with ventralight st mesh.Per operative notes, "there was a ventralex st mesh (device #1) that was scrunched up in a taco-like fashion in the left lower quadrant.This contained adhesions to bowel and omentum, which took down carefully.Once the entire incarcerated bowel was freed, introduced a ventralight st (device #2) and secured." (b)(6) 2015 to (b)(6) 2015 - patient was diagnosed with abdominal pain, sepsis, incarcerated bowel obstruction and hospitalized with ventilatory support.(b)(6) 2015 - patient was diagnosed with peritoneal abscess, transverse colonic perforation, dense peritoneal adhesions and mass thereby underwent open enterolysis with explant of meshes (device #1 & #2).Per operative notes, "upon entry of the peritoneal cavity, there was pus and liquid feces evacuated.Superficial to the mesh, the abscess cavity was carefully explored and evacuated of all contamination.Posterior to the mesh, another abscess cavity was entered, and copious amounts of liquid stool evacuated.Excised the foreign body mesh (device #1 & #2).¿ attorney alleged that the patient had abscess, adhesions, bowel obstruction, bowel perforation, mesh migration, nausea, emesis and severe abdominal pain and emotional injuries.It is alleged that the mesh was found to be "scrunched up in a taco like fashion".It was also alleged that few days post revision surgery, patient became seriously ill, developed abscess and perforation in the colon.It is alleged that patient underwent another surgery and both the meshes were explanted, ended up spending one month in the hospital and forced to have a colostomy bag.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical record review, patient with complex medical history who also had alcoholic cirrhosis, about 12 days post implant of ventralight st was diagnosed with sepsis, bowel perforation, small bowel obstruction, abscess, peritonitis, hernia recurrence, infection, abdominal pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and infection as possible complications.In regards to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." this emdr represents the ventralight st (device #2).An additional supplemental emdr was submitted to represent the ventralex st (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.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: 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: 17378264
• Report Number: 1213643-2023-092970
• Device Sequence Number: 14934843
• Product Code: FTL
• UDI-Device Identifier: 00801741031649
• UDI-Public: (01)00801741031649
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2016
• Device Catalogue Number: 5954610
• Device Lot Number: HUYI0438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 110 KG