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Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 02/11/2013
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2012 whereby a gore® dualmesh® plus biomaterial with holes was implanted. The complaint alleges that on (b)(6) 2013 and (b)(6) 2017, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infection, mesh removal, recurrence, adhesions, pain and suffering. Additional event specific information was not provided.
Manufacturer Narrative
(b)(4). The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)]. Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: on (b)(6) 2012: (b)(6) healthcare system, (b)(6) hospital. (b)(6), m. D. Indications: ¿this patient has had previous midline incision. A hernia was occurring around the umbilicus. It looked like it was partially the result of an umbilical hernia which was pre-existing and an incisional hernia. ¿ implant procedure: repair of large ventral hernia with 16 x 20 mesh. [implant: gore® dualmesh® plus biomaterial with holes, 1dlmcph04/no information, 15cm x 19cm x 1. 5 mm thick, oval with holes] implant date: (b)(6) 2012 [hospitalization (b)(6) 2012]. Wound classification: [not provided]. On (b)(6) 2012: (b)(6) healthcare system, (b)(6) hosptial. (b)(6), m. D. Operative report. Anesthesia: general/endotracheal. Preoperative and postoperative diagnosis: ventral hernia. Findings: ¿the patient had a chronic ventral hernia. We were able to reduce this totally. The fascia was not distributed that was intact. We did free the omentum and intestine from the wall and were able to place a 16 x 20cm dual mesh graft. ¿ procedure: ¿with the patient in the supine position under satisfactory endotracheal anesthesia the abdomen was prepped and draped in the usual sterile fashion. And incision was made at the level of the umbilicus. The hernia sac was identified and then dissected free from the surrounding tissue. The hernia was then reduced into the abdominal cavity. The sac was resected. We then placed 2-0 prolene sutures on the 16 x 20 mesh. We had six sutures present. These replaced appropriately and then the abdominal wall was brought upward. We then placed several stitches in between some of the fixations to prevent any bow from herniating into the potential defect around the fixation points. The fascia was then closed with 0 prolene. Irrigation was accomplished. The abdominal wall was then closed in layers. Sterile dressings were applied. The patient was then awakened and taken to recovery in satisfactory condition. ¿ on (b)(6) 2012: (b)(6) healthcare system, (b)(6) hospital. Implant record: inventory item: ¿mesh srg dualmesh plus 19x15cm soft tiss biomaterial antimicrobial hole strl gore-tex chlorhexidine¿. Implant name: ¿mesh dual plus holes 1. 5mm x 15x19cm - log201786. ¿ model/cat no: 1dlmcph04. Manufacturer: wl gore and associates. Number used: 1. Area: abdomen. Relevant medical information: on (b)(6). (b)(6) 2013: (b)(6) hospital. [operative report for explant not provided. ] on (b)(6). (b)(6) 2013: (b)(6) hospital. (b)(6), m. D. Surgical pathology report. Tissue submitted: umbilicus and infected mesh. ¿final diagnosis: umbilicus and mesh; hernia repair: skin and subcutaneous tissue with fibrosis, fat necrosis, foreign body granulomatous inflammation and hemosiderin deposition. Synthetic mesh material, see gross description. ¿ gross description: ¿the specimen labeled (b)(6) and ¿umbilicus and infected mesh¿ is received in formalin and consists of a 15. 3 x 10. 1 x 0. 2 cm rectangular shaped portion of synthetic yellow-green mesh like material. Multiple unoriented blue suture ties are embedded within mesh-like material. No sections are taken. Also submitted in the same container is a 7. 6 x 6. 6 x 3. 9 cm irregular shaped portion of soft, yellow-tan glistening adipose tissue with an attached 3. 5 x 2. 7 cm ellipse of wrinkled yellow-tan skin. Centrally located on the portion of the skin is a 0. 6 cm in greatest dimension puckered possible umbilicus. The specimen is serially sectioned and the cut surface reveals soft yellow-tan glistening adipose tissue and dense green-white fibrous tissue. Evidence of the yellow white fat necrosis is identified filling the dense grey-white yellow green fibrous tissue. Two representative sections are submitted in two cassettes. Microscopic description: microscopic examination of the tissue processed is performed. ¿ [microscopic description not provided]. On (b)(6) 2017: (b)(6) hospital. (b)(6), m. D. Operative report. Repair of recurrent incisional hernia with mesh, lysis of adhesions, small bowel resection. [implant: phasix overlay]. Assistant: (b)(6), cst. Anesthesia: general. Estimated blood loss: 150ml. Pre-operative diagnosis: recurrent ventral incisional hernia. Post-operative diagnosis: recurrent ventral incisional hernia. Findings: ¿multiple adhesions. ¿ procedure: ¿the patient was brought to the operating room and transferred on the operating room table in the supine position. Scd's (sequential compression device) were placed on bilateral lower extremities, general anesthesia was induced, and the patient was successfully intubated. A foley catheter was placed under sterile conditions. The abdomen was prepped and draped in the usual sterile fashion, and time out was performed. She received clindamycin iv. A lower midline incision was made with a scalpel. I carefully dissected down with the electrocautery, through the subcutaneous tissue, until we encountered the hernia. There was a large hernia sac. The bowel was very adherent to this. The edges of the fascia were grasped. The hernia sac was dissected off. I then began a tedious lysis of adhesions. These were all up to the anterior abdominal wall. Inherent to the procedure, there was one serosal injury that was over showed with several silk stitches. Also, due to the intense adhesions, the small bowel was entered. A small bowel resection was performed. The mesentery was circumvented and taken down with the ligasure device. Two small enterotomy's were made to circumvent the defect. The gia blue load 80 stapler was introduced. This was fired to create anastomosis. In additional firing was required to close the anastomosis. The mesenteric defect was closed with a 3-0 vicryl stitch. Once all of the adhesions were taken down, the facial edges were grasped. These were cleared off circumferentially. The fascia was then closed with a #1 pds; one from the top of the incision, one from the bottom. These were met in the middle and tied off. The fascia was irrigated. I made sure there was adequate hemostasis. A piece of 15 x 20 cm of phasix mesh was placed as an overlay. This was tacked down to the underlying fascia with a 2-0 vicryl stitches. An 18 (b)(6) was placed on top of the mesh. A small stab incision was made in the left lower quadrant. This was sutured in place with a nylon stitch. The tissue was then tacked down to the phasix mesh with interrupted 2-0 vicryl stitches. The dermis was closed with a running 3-0 vicryl stitch. Skin stapler was used to close the incision. The patient was then awakened, extubated, the foley catheter was removed, and the patient was transferred to recovery room in stable condition. ¿ on (b)(6) 2017: (b)(6) hospital. ¿specimens: suture granuloma: culture, aerobic. Culture anaerobic, smear, gram stain. Small bowel: tissue. Small bowel. Pathology surgical. Hernia sac: tissue. Soft tissue. Pathology surgical. [pathology report not provided for specimens that were collected during the (b)(6) 2017 procedure. ] a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information. It should be noted that the gore® dualmesh® plus biomaterial with holes instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence. " the gore® dualmesh® plus biomaterial with holes instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ".
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Manufacturer (Section D)
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
vanessa rodriguez
1505 n. fourth street
flagstaff, AZ 86004
MDR Report Key13289793
MDR Text Key287676874
Report Number3003910212-2022-01324
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/19/2022 Patient Sequence Number: 1