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Device Problems Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 06/11/2004
Event Type  Injury  
Manufacturer Narrative
(b)(4). This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time. No further investigation is required at this time. Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable. Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as false claim, no problem detected, and ¿withdrawn. ¿ previous patient code (b)(4) was reported based on the original complaint and is no longer applicable per gore¿s investigation. Medical records: the known medical records span (b)(6) 1997 through (b)(6) 2007 and not all records received in this time span are relevant to the two unknown gore devices, the gore® mycromesh® biomaterial, or the gore® mycromesh® plus biomaterial. Medical records from (b)(6) 1997 through (b)(6) 2004 were not provided. Patient information: medical history: 1996: motor vehicle accident with major abdominal trauma. Surgical procedures: date unknown: appendectomy. 1996: three abdominal surgeries for liver injury. (b)(6) 1997: repair of multiple ventral incisional hernias with bi-layer gore-tex mesh. Implant: 4 devices, captured as gore-tex® soft tissue patch (referred to as ¿gore-tex mesh¿, product id indecipherable), captured as gore-tex® soft tissue patch (referred to as ¿gore-tex mesh¿, product id indecipherable), captured as gore® mycromesh® plus biomaterial (referred to as ¿gore-tex mesh¿; records show use of ¿fenestrated micro-mesh", ¿impregnated with antibacterial solution¿, product id indecipherable), captured as gore® mycromesh® biomaterial (referred to as ¿gore-tex mesh¿; records show ¿fenestrated micro-mesh", product id indecipherable). Implant #1, #2, #3, #4 preoperative complaints: (b)(6) 1997: ¿presented to the office complaining of a bulge just to the left of the midline of the umbilicus. He was evaluated and scheduled for surgery. Abdomen; soft, bulge left mid abdomen lateral to the umbilicus, three fingerbreadth defect. Reduces easily, increases on valsalva. It possibly encompasses the umbilicus. Incisional hernia. S/p multiple operations. ¿ ¿over a year ago was in a motor vehicle accident and had major abdominal trauma. He underwent three abdominal operations for liver injury. He presented to the office recently with a bulge just lateral to his umbilicus. He was found to have an incisional hernia, was evaluated, and scheduled for surgery. ¿ implant #1, #2, #3, #4 procedure: repair of multiple ventral incisional hernias with bi-layer gore-tex mesh. [implant: 4 devices, #1 captured as gore-tex® soft tissue patch (referred to as ¿gore-tex mesh¿, product id indecipherable), #2 captured as gore-tex® soft tissue patch (referred to as ¿gore-tex mesh¿, product id indecipherable), #3 captured as gore® mycromesh® plus biomaterial (referred to as ¿gore-tex mesh¿; records show use of ¿fenestrated micro-mesh", ¿impregnated with antibacterial solution¿, product id indecipherable), #4 captured as gore® mycromesh® biomaterial (referred to as ¿gore-tex mesh¿; records show ¿fenestrated micro-mesh", product id indecipherable)]. Implant #1, #2, #3, #4 date: (b)(6) 1997 [hospitalization (b)(6), 1997]: description of hernia being treated: ¿the patient had midline incision from the xiphoid to just above the symphysis pubis. There was a bulge just to the left of the umbilicus. An elliptical incision was made beginning at the mid upper abdomen, around the incision, around the umbilicus, down toward the symphysis and carried through the skin and subcutaneous tissue. The old scar with the umbilicus was removed. A small defect was then seen just to the left of the umbilicus. The fascia was grasped and opened superiorly. There were abdominal wall adhesions. These were taken down as we went. We opened up to the mid upper abdomen and down to the mid lower abdomen below the umbilicus. There was a fairly large defect lateral to the umbilicus and there was bowel and omentum stuck in that. This was taken down with sharp dissection. Adhesions were taken off the left abdominal wall using sharp dissection and off the right abdominal wall with sharp dissection. The good fascia was very laterally (sic) on each side. We felt superiorly and there were several hernias in the abdominal wall superiorly, so therefore we ended up opening the fascia all the way to the xiphoid. As mentioned, there were multiple hernias. The adhesions were cleaned off the abdominal wall completely around the incision laterally and superiorly and inferiorly. We also opened the incision inferiorly almost down to the pubis. The fascia was very thin near the midline and a lot of fascia was totally excised. At this time we had a large defect encompassing the whole abdominal wall. When we pulled the fascia together it was too tight, so therefore we felt we had to do a primary mesh repair. ¿ implant size and fixation: ¿we decided to do a two layer with the smooth gore-tex mesh on the inside and the fenestrated micro-mesh on the outside. The mesh that we used was 1. 0 mm thick. The first piece of mesh was taken and placed inside the fascia and laid over the bowel. It was sutured to the fascia with large fascial stitches with #0 gore-tex running suture. This was done superiorly and then down each side about half way down the defect. Another large piece of mesh was taken and placed inside the fascia and over the bowel. We sutured mesh to mesh across the midline with #0 gore-tex running suture. Then the mesh was sutured to the fascia on each side and inferiorly with #0 gore-tex running suture. This formed a nice covering over the bowel with good fascial bites and good strong repair. We then took some fenestrated micro-mesh which was 1. 0 mm thick. The top one was impregnated with antibacterial solution. This was sutured on top of the fascia with #0 gore-tex running sutures beginning superiorly and then down each side about midway down the defect. Another piece of fenestrated micro-mesh was taken and laid inferior to that. Mesh was sutured to the mesh transversely with #0 gore-tex suture and then sutured to the fascia with #0 gore-tex running suture on each side and then inferiorly. This formed a nice tight bi-layer covering of mesh. The wound was irrigated thoroughly with kefzol solution. Hemostasis was maintained. Three jackson-pratt drains were laid in and brought out through the abdominal wall and sutured with #2-0 silk suture. ¿ on (b)(6) 1997: pathology. ¿sections of the abdominal scar show skin with an intact mature keratinizing stratified squamous epidermis. Within the dermis there is dermal fibrosis consistent with clinical diagnosis of scar. Sections of the omentum show mature adipose tissue with focal hemorrhage and focally covered by a connective tissue showing fibrosis with hyalinization. ¿ on (b)(6) 1997: discharge summary: ¿underwent repair of multiple ventral incisional hernias with placement of two layers of gore-tex mesh. His post-operative course has been absolutely benign. He is now tolerating a regular diet and ready for discharge. His wound looks good and half of his staples have been removed. His jackson-pratt drains are still in. Draining 60 cc a day. ¿ medical records from (b)(6) 1997 through (b)(6) 2004 were not provided. Explant #1, #2, #3, #4 preoperative complaints: (b)(6) 2004: operative indications. ¿status post exploratory laparotomy for a grade iv liver laceration from an mvc [motor vehicle collision] in 1996 with subsequent ventral hernia repair with gore-tex mesh the following year. He apparently noted some fatigue and was found to have an infection on cat scan three months ago. Ct-guided drains placed, two with culture positive for pseudomonas. Has been on iv meropenem through a picc line for the past two months and was referred to us for further treatment which consisted of scheduling for removal of the infected mesh. ¿ ct scan and ct-guided diagnostic procedure records, culture records and treatment records, for the above outlined episode of care, have not been provided. Explant #1, #2, #3, #4 procedure: removal of infected gore-tex mesh, placement of absorbable mesh and repair of recurrent ventral incisional hernia. Explant #1, #2, #3, #4 date: (b)(6) 2004: ¿a midline incision was performed through his old incision incising the scar, carried down to the gore-tex mesh. The gore-tex mesh was entered and there was an abscess cavity beneath the two layers of gore-tex mesh. There actually were two layers of gore-tex mesh sewn in with a pseudocapsule around it. This was opened midline and the pseudocapsule was carefully dissected bilaterally to the edge of the gore-tex mesh which was then removed from the fascial edges and care was taken not to injure the underlying bowel. The entire gore-tex was removed in this fashion, cutting sutures as they were encountered and removing them and draining the abscess cavity between the two layers of mesh. The bottom layer of gore-tex mesh was folded over on itself and the small bowel was densely adherent to this and the pseudocapsule was taken down from this with the bowel along with it and that is where the largest abscess cavity was and the gore-tex mesh was completely excised and passed off the field as specimen. The abdomen was then irrigated with several layers of saline. There was the recurrent ventral incisional hernia superior to the prior mesh up near the xiphoid. ¿ on (b)(6) 2004: pathology. ¿description of specimen: gortex mesh. Gross description: a single specimen is received in formalin labeled goretex mesh (for gross only) and consists of multiple fragments of slightly thick and smooth tan mesh material with identifiable suture. The entire specimen measures in aggregate approximately 30 cm x 12. 5 x 0. 3 cm in greatest dimension. A scant amount of soft material tissue is adherent which measures 4. 0 x 2. 5 x 0. 5 cm. Microscopic description/comment: i have reviewed all diagnostic slides and have edited the gross and/or microscopic portion of this report as part of my pathologic assessment and final diagnosis. Icd 9: 996. 60 infection inflammation. Device graft, unspec device. ¿ conclusion: implant #4 ¿gore-tex mesh¿, ¿fenestrated micro-mesh", captured as gore® mycromesh® biomaterial. It should be noted that the gore® mycromesh® biomaterial instructions for use include warnings and 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 instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device. Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management. Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene. As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh. These my include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery. Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures. The above inherent risks are typically detailed in standard informed consent documents. There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code (b)(4) is being used. Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device. This device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted. After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed. Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6)1997 whereby an alleged gore device was implanted. The complaint alleges that on (b)(6) 2004, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: mesh infection, removal and additional surgery. Additional event specific information was not provided.
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Manufacturer (Section D)
flagstaff AZ
Manufacturer (Section G)
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
rena gros
1500 n. 4th street
MDR Report Key12468888
MDR Text Key273818021
Report Number2017233-2021-00003
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
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 Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1