• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMC06
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 12/26/2007
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2007 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2007, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infection, abdominal pain, hernia recurrence, and the need for additional surgical intervention. Additional event specific information was not provided.
 
Manufacturer Narrative
Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: relevant medical information: on (b)(6) 2005: facility not provided. (b)(6) md. Office visit: chief complaint: ¿stomach mass and sigmoid diverticulosis. ¿ history of present illness: ¿(b)(6) female who presents with a history of sigmoid diverticulitis. During her work up for the abdominal pain she was found to have a stomach mass on cat scan. Her abdominal pain resolved with antibiotics. ¿ review of systems: ¿gas, heartburn, nausea, stomach pain. ¿ physical exam: ¿abdomen: a mass or defect is not appreciated. Previous incisions are present. ¿ assessment: ¿diagnosis: sigmoid diverticulitis ¿ resolved, stomach mass. Plan: this is a (b)(6) female presents with a complaint of a stomach mass and sigmoid diverticulitis. The patient will be scheduled for upper and lower endoscopy in order to rule out a mass, peptic ulcer, polyps, diverticulosis, or inflammatory disease. The patient was explained the procedure of an egd [esophagogastroduodenoscopy] and colonoscopy with iv [intravenous] sedation. The patient was explained the risk and benefits, including bleeding and perforation. The patient was also instructed on the bowel prep and to no longer take any aspirin or motrin prior to the procedure. ¿ on (b)(6) 2005: (b)(6) hospital. (b)(6) md. Operative report. Procedure: 1. Egd with cold forceps biopsies. 2. Colonoscopy with biopsies. Preoperative diagnosis: ¿abnormal ct scan which showed a mass in the stomach and recent history of diverticulitis. Postoperative diagnosis: 1. Small hiatal hernia. 2. Gastroesophageal junction mass. 3. Gastric polyps in the cardia. 4. Diverticulosis of the sigmoid. 5. Ascending colon polyps. 6. External hemorrhoids. Specimens: 1. Gastric polyps. 2. Gastric mass. 3. Antrum. 4. Ascending colon polyps. ¿ on (b)(6) 2005: (b)(6) hospital. (b)(6) md. Laboratory results: ¿diagnosis: gastric polyps, biopsy (a): fundic gland polyps. Negative for helicobacter pylori like organisms. Tissue designated gastric mass, biopsy (b): mild edema and chronic inflammation. Comment: in the tissue sampling designated gastric mass microscopically there is a granular mucosa with mild edema and chronic inflammation in the lamina propria. Dysplastic epithelium and neoplasm is not seen in the sampling. Clinical correlation is recommended with additional biopsy if these findings are inconsistent with the endoscopic impression. ¿ on (b)(6) 2006: facility not provided. (b)(6) md. Office visit: cc [chief complaint]: ¿gastric mass. ¿ subjective: ¿(b)(6) [sic] female presents for discussion of surgery options for her gastric mass. Old notes were reviewed. The patient has no new complaints. ¿ ros [review of symptoms]: ¿gas; heartburn; stomach pain. ¿ physical exam: ¿abdomen: abdominal wall hernia is not present. ¿ assessment: ¿diagnosis: gastric mass. Plan: this is a (b)(6) [sic]female with gastric mass at the ge [gastroesophageal] junction diagnosed by gastroscopy. The patient was explained the [sic] a gastric resection would be performed to remove the diseased portion of the stomach. The laparotomy would include frozen section and evaluating the intraabdominal organs for disease. Biopsy of these organs as well as suspicious [sic] lymph notes would be performed if necessary. The risks and benefits of the procedure was [sic] explained, including bleeding, infection, failure of the anastomosis, chronic diarrhea, weight loss and/or need for a subtotal or total gastrectomy. As well as admission to the hospital for postop care. The patient understood and agreed to have the procedure performed. ¿ on (b)(6) 2006 ¿ on (b)(6) 2006: (b)(6) hospital. Inpatient admission. On (b)(6) 2006: (b)(6) hospital. (b)(6) md. Operative report. Assistant: dr. (b)(6). Procedure: partial gastrectomy. Preoperative diagnosis: gastric mass. Postoperative diagnosis: benign neoplasm of the stomach or leiomyoma. Anesthesia: general. Estimate blood loss: less than 100. Drain: none. Specimen: gastric portion of the stomach with mass. Procedure: ¿the patient was brought into the operating room and placed on the table in the supine position. The abdomen was cleaned, prepped, and draped in a sterile fashion. The skin was injected with local anesthesia from the xiphoid to the umbilicus. A vertical incision was then made and taken down through the skin and subcutaneous tissue to the fascia, which was opened with electrocautery; and the peritoneum was then opened. The balfour retractors were set up, and the bowel within the abdomen was retracted out of the field. A babcock was used to grasp a portion of the stomach in order to examine the stomach. The mass appeared to be on the posterior side of the stomach near the ge junction. Our attention then turned to the lesser curvature of the stomach where the greater sac was opened in the standard fashion with suture ligation. The short gasters were taken down from the spleen, and the cardia of the stomach was dissected free. The esophagus was appreciated and dissected circumferentially in order to place a penrose drain around it. The lesser curvature of the stomach was also dissected free using suture ligation techniques in the standard fashion. Once this was performed, a bougie size 52 was placed down the esophagus in order to determine the width of the esophagus at the ge junction. The laparoscopic endostapler was then used to staple across the cardia of the stomach in order to resect the area which contained the mass. It was sent off the table to pathology for frozen section. There was a small laceration near the hilum of the spleen, which had bled. This was packed off with a lap sponge. Once the report came back of a leiomyoma, the bougie was removed, and an ng [nasogastric] tube replaced. The packing around the spleen was removed and a small amount of oozing was seen. Surgiseal was then packed over that. The remaining portion of the cardia of the stomach was then tacked down to the esophagus to prevent further folding over or flopping of the stomach. The abdomen was irrigated and suctioned dry. The laps were removed from around the spleen. The bleeding and oozing had stopped around the spleen incision. The surgiseal was left in place. The midline incision was then closed with 1 pds looped suture in a continuous running stitch x 2. The skin was closed with staples. The bandage and 4 x 4's were applied. The patient was extubated and taken to the recovery room in stable condition. All instrument, needle, and lap counts as well as balfour count was correct at the end of the procedure. ¿ on (b)(6) 2006: (b)(6) hospital. (b)(6) md. Pathology. Specimen submitted: ¿a. Gastric mass for frozen section. ¿ gross description: ¿received fresh labeled ¿gastric mass frozen section¿ is one piece of gastric tissue measuring 5 cm in length and 5 cm in diameter. There is a submucosal tumor which measures 3. 5 x 2. 5 x 2. 5 cm. The overlying mucosa is intact except for a tiny small superficial ulcer or erosion. The tumor is well-circumscribed, multinodular, white, and firm. It is uniform in color and consistency. A representative session is cemented for frozen section. Additional representative sections are smooth for permanents and eight additional cassettes as follows: al - tumor; and margins. Intraoperative consultation with frozen section: gastroesophageal junction and/or proximal stomach, tumor resection -- stromal tumor. Atypical features and histologic features diagnostic of malignancy are not present at frozen section. ¿ microscopic description: ¿the tumor is composed of cells with abundant eosinophilic cytoplasm. The tumor is relatively hypocellular. The tumor cells are uniformly dispersed. The tumor cells and their nuclei are uniform in size and shape and they exhibit no atypia. There is no nuclear enlargement, hyperchromasia, nuclear membrane irregularities nor atypical chromatin changes. There are no nucleoli. No mitotic figures are identified. There is no necrosis. Immunohistochemistry strains are performed. The tumor immunophenotype is: muscle specific actin positive, (b)(6), and vimentin negative. ¿ diagnosis: ¿proximal stomach, resection ¿ leiomyoma. ¿ on (b)(6) 2006: (b)(6) hospital. (b)(6) (b)(6), md. Discharge summary. Hospital course: ¿this is a (b)(6) female who was admitted to the hospital for partial gastric resection of the mass in the cardia of the stomach. It was found to be a benign leiomyoma. On postop day 1 she was doing well but having some shortness of breath and these inhalers were started including albuterol and advair. Her pain was controlled well with the pca pump. She was advanced to a regular diet on postop day 5 and discharged home on postop day 6. She will follow up in my office in 1 to 2 weeks fore removal of her midline incision staples and postop evaluation. ¿ on (b)(6) 2006: facility not provided. (b)(6) md. Office visit. Cc: ¿lump at top of incision. ¿ subjective: ¿(b)(6) [sic] female presents for reevaluation of incision. The mass is in the area were [sic] her wound opened postoperatively. It is more noticeable when she stands. She states after she eats the mass gets larger. It usually reduces on its own. She denies nausea, vomiting, diarrhea and constipation. She states the pain gets up to a 4 or 5/10 when she is bloated. ¿ ros: ¿stomach pain. ¿ physical exam: ¿abdomen: an incisional hernia is present in the upper portion of the midline. ¿ assessment: ¿diagnosis: hernia, incisional. ¿ plan: ¿this is a (b)(6) [sic] female who presents with a [sic] incisional hernia. The patient was explained the procedure of repair of incisional hernia with mesh. The patient was explained the risk and benefits of the procedure including pain, bleeding and infection. The patient was also explained that there will be some swelling, bruising and a scar present postoperatively. The patient is also placed on the weightlifting restrictions of nothing greater than 5 pounds for one-week postoperatively. The patient agreed and will be scheduled for surgery. ¿ on (b)(6) 2006:(b)(6) hospital. (b)(6) md. Operative report. Procedure: [procedure name not provided]. Pre and postoperative diagnosis: incisional hernia repair. Anesthesia: general. Estimated blood loss: minimal. Specimen: 1. Incisional scar. 2. Culture swab of fluid collection in the abdominal wound. Drains: none. Procedure: ¿the patient was brought into the operating room and placed on the table is [sic] supine position. The abdomen was cleaned, prepped, and draped in a sterile fashion after general anesthesia was induced. The midline incision was injected with local anesthesia. The thickened scar was excised and sent off the table as a specimen. The incision was then taken down through the subcutaneous tissue where in the upper portion of the incision there was a 5 cm pocket of white fluid. This was cultured and suctioned. The incision was then further taken down through further scar tissue, and through the fascia and peritoneum. Adhesions were taken down around the incision circumferentially. The abdomen was then irrigated as well as the wound. The fascia was then closed using #1 pds loop in a continuous running stitch x 2. The subcutaneous tissue was approximated with 3-0 vicryl in interrupted stitches. The skin was closed with 4-0 monocryl in a continuous running subcuticular stitch. The wound was cleaned and dried. Steri-strips and bandages applied. The patient tolerated the procedure well and was taken to the recovery room in stable condition. ¿ implant #1 preoperative complaints: 2007: facility not provided. (b)(6) md. Office visit. Chief complaint: ¿possible hernia. ¿ history of present illness: ¿this is a (b)(6) [sic] female who presents with the complaint of incisional hernia. The patient states the hernia was first noticed september and has caused pain and has increased in size. She also notices when the bulge is large she has return of her heartburn. ¿ review of symptoms: ¿stomach pain. ¿ physical exam: ¿abdomen: a mass is appreciated to the left of her midline incision above the umbilicus. Previous incisions are present. ¿ assessment: ¿hernia, incisional. ¿ plan: ¿this is a (b)(6) female who presents with a laparoscopic incisional hernia. The patient was explained the procedure of repair of incisional hernia with mesh. The patient was explained the risks and benefits of the procedure including plain, bleeding and infection. The patient was also explained that there will be some swelling, bruising and a scar present postoperatively. The patient is also placed on weightlifting restriction of nothing greater than 10 pounds for one-week postoperatively. The patient agreed and will be scheduled for surgery. ¿ implant #1 procedure: laparoscopic lysis of adhesions and incisional hernia repair converted to incisional hernia repair. [implant: ¿dual mesh¿, no was pid provided] implant #1 date: on (b)(6) 2007 [hospitalization dates on (b)(6) 2007] on (b)(6) 2007: (b)(6) hospital. (b)(6) md. Operative report. Pre and postoperative diagnosis: recurrent incisional hernia. Anesthesia: general. Estimated blood loss: minimal. Specimen: none. Wound classification: not provided. Findings: ¿large epigastric abdominal wall incisional hernia with the upper edges of the hernia involving the chest wall and extending back under the rib cage. The procedure was then converted to open because there was no healthy tissue to tack the mesh on the upper portion of the abdominal wall that would not compromise the thoracic space. ¿ procedure: ¿the patient was taken to the operating room and placed on the table in the supine position. After general anesthesia was induced, the abdomen was cleaned, prepped, and draped in a sterile fashion. The skin around the umbilicus was injected with local anesthesia. A vertical incision made, and blunt dissection was used to open the fascia. The 10 mm trocar was able to be placed directly in the umbilicus. The camera was introduced, and adhesions were seen. Our attention then turned to the left side of the abdomen where the skin was anesthetized with local anesthesia, and a 5 mm incision made. A 5 mm trocar placed under direct vision. Our attention turned to the right upper quadrant where the skin was anesthetized with local anesthesia. A 5 mm incision was made, and a 5 mm trocar placed under direct vision. Sharp dissection was then used to take the adhesions that were in the hernia down. Omentum and the transverse colon were found to be in the hernia. Once the hernia was free of the adhesions, the edges of the hernia were evaluated. The upper portions of the hernia extended under the rib cage, xiphoid, and rib cage on the left; and there were no places where we can place our upper tacking sutures in order to hold the suture in place nor was there an area where we can do adequate tacking of the mesh superiorly. It was decided at that time, that i will convert the procedure to open in order to be able to close the hernia with dual mesh. The pneumoperitoneum was released, and the incision was made in her previo. Is midline incision after the skin was anesthetized. Once this had occurred, the hernia sac was dissected down, and the edges of the hernia sac were found. The dual mesh was then tacked around the edges on top of the hernia sac edges circumferentially except for at the very top where the xiphoid was exposed. Prolene sutures were also used, and interrupted stitches circumferentially to hold the mesh in place. Once this was performed, the subcutaneous tissue was approximated over the mesh using 3-0 vicryl in interrupted stitches and tacking it down to the mesh. The skin was closed with staples. The wound was cleaned and dried. Steri-strips and bandages applied. The patient tolerated the procedure well and was taken to the recovery room in stable condition. She will be admitted overnight for pain control and nausea control. ¿ on (b)(6) 2007: (b)(6) hospital. (b)(6) md. Discharge summary. Hospital course: ¿this is a (b)(6) female who was admitted to the hospital after her laparoscopic incisional hernia repair was converted to an open incision hernia repair. During the procedure she was found to have a very large defect, which extended up to the chest and laparoscopically it was unable to be repaired. Postoperative she had significant pain from the incisional hernia and required iv pain medication for pain control. She was admitted to the hospital at that point and on the date of her discharge she was afebrile. Her vital signs were stable. She had tolerated a clear liquid diet as well as a regular diet and her pain was controlled with one vicodin. Her lungs were clear to auscultation. Heart was regular rate and rhythm. Abdomen, bowel sounds were positive. Her incision was clean and dry. Assessment and plan: status post incisional hernia repair with mesh. She will follow up with me in my office in one to two weeks for wound check. ¿ implant #2 preoperative complaints: on (b)(6) 2007: (b)(6) health. (b)(6) md. History and physical. ¿chief complaint: recurrent abdominal incisional hernia. History of present illness: this is a (b)(6) woman who previously underwent a partial gastric resection for a polyp that was complicated by a wound infection and subsequently an incisional hernia. This was repaired primarily but it recurred and last may was repaired again with mesh but by (b)(6) another hernia had recurred. She presents now for repair of recurrent abdominal incisional hernia. ¿ review of systems: ¿does have indigestion but no change in stool. ¿ physical examination: ¿abdomen: protuberant, there is a well-healed midline incision with an obvious hernia in the upper midline portion of the incision. Fascial edges can be appreciated circumferentially. It is only mildly tender. ¿ impression and plan: ¿the patient has a recurrent abdominal wall incisional hernia. I have recommended repair to keep it from becoming larger. We will need to remove the previously placed mesh and using [sic] a new piece of mesh for repair. The key is getting good overlap and solid fixation. I have explained that recurrence is still a risk. We will plan to do this under general anesthetics. We will use perioperative antibiotics. I explained that bleeding is an unlikely risk. We have also discussed dvt [deep vein thrombosis] prophylaxis. We talked about anticipated time in the hospital and the issues regarding convalescence. I have emphasized the need not to do any straining for at least the first six weeks, to let her repair the [sic] chance to heal stronger at it¿s [sic] strongest. After reviewing these issues in detail with the patient and answering her questions, she has agreed to proceed and presents now for repair of recurrent abdominal incisional hernia. ¿ on (b)(6) 2007: (b)(6) health. (b)(6) md. Indications: ¿this is a (b)(6) female who has previously underwent a partial gastric resection for polyp and needs [sic] to be removed in an outside facility. This was complicated by a wound infection and subsequently an incisional hernias [sic] incisional hernia was repaired primarily and then repaired with mesh type closure and now presents due to recurrence. ¿ implant #2 procedure: open ventral hernia repair with mesh. [implant: gore® dualmesh® biomaterial,/04917574 , x thick] implant #2 date: on (b)(6) 2007 [hospitalization dates unknown] on (b)(6) 2007: (b)(6) health. (b)(6) md. Operative report. Assistant: michael boros, md. Pre-and postoperative diagnoses: recurrent ventral hernia. Anesthesia: general. Estimated blood loss: minimal. Drains: jp [jackson pratt]. Specimens: hernia sac to pathology. Complications: none. Wound classification: not provided. Procedure: ¿after all risks and benefits were discussed, questions answered, consent was obtained, the patient taken [sic] the operating [sic] laid in supine position. General endotracheal anesthesia was induced without difficulty. A pause was done to identify the patient, procedure, surgeon and to establish a neutral zone. The abdomen was pepped with betadine and draped with sterile towels and drapes. An ioban was placed over the skin and drapes. An incision was made with a number 10 scalpel blade. The incision included the entire anterior abdominal wall scar which was removed and sent from the field. Using bovie with cautery. Soft tissues were dissected around the hernia sac back to good fascial edges, the hernia sac was opened and the [sic] multiple adhesions were found including the omentum, small bowel and transverse colon. These were gently taken down with blunt dissection and then bovied with cautery. There was a defect in the omentum, therefore, it was split. This was done with two hemostats and 2-0 silk ties. Using the above cautery, the hernia sac was carefully dissected off the fascial edges and removed from the field and sent to pathology. Over 2 centimeters of clear fascia was dissected free to allow good closure and overlapping over underlying mesh. Once the fascial edges were exposed, a defect roughly measured 18 x 20 centimeters [sic] superior portion was near the xiphoid process in the lower rib cage. The mesh was then brought on the field, cut to size. A gore-tex mesh was placed in a relaxed fashion and sewn into place with interrupted 2-0 prolene sutures in a horizontal mattress fashion circumferentially around the defect. The mesh was palpated once in place. There were no evident gaps or spaces. Therefore, a 2-0 vicryl in a figure-of-eight fashion was used to close the soft tissues over the mesh. The skin was reapproximated with staples. Before the 2-0 vicryls were used and [sic] a jp drain was placed from separate stab incision and secured with a 3-0 nylon to be placed in the ____ between the mesh and soft tissues. This patient was taken stable to postanesthesia [sic] recovery room. Dr. (b)(6) was present for the entire procedure. ¿ on (b)(6) 2007: (b)(6) medical center. Implant sticker: ¿gore dualmesh biomaterial. ¿ manufacturer: (b)(4) gore & associates. Ref catalogue #:, lot #: 04917574. On (b)(6) 2007: (b)(6) medical center. (b)(6) md. Pathology. Diagnosis: ¿region of incision, herniorrhaphy: hernia tissues. ¿ microscopic description: ¿this is a fibroadipose tissue without evidence of malignancy. ¿ gross description: ¿this is a 21 x 9 x up to 2 cm in thickness segment of fat. On one surface there is an 11 x 9 cm segment of mesh firmly adherent to the fat. There is no mass lesion and areas of exudate are not grossly evident. A 3 x 1. 5 cm area of membranous serosal apparent tissue is identified on the surface opposite the mesh while more abundant membranous tissue is present overlying the mesh and areas of this serosal surface are sampled. ¿ explant preoperative complaints: on (b)(6) 2007: (b)(6) health. (b)(6) md. History and physical. Chief complaint: ¿wound infection. ¿ history of present illness: ¿this is a (b)(6) caucasian female who is 3 weeks status post ventral hernia repair with mesh by dr. (b)(6). She saw dr. (b)(6) 6 days prior to this admission in the office where the wound was healing well, and there were no complaints. She was under the impression she was doing well. Three days prior to admission the patient noted some pain and swelling. Yesterday she went to marshall emergency room where she was noted to be afebrile with normal white count. A ct scan was performed which suggested a seroma of the wound. There is no drainage. No infection and she was sent home. This morning she noted purulent drainage from the upper 2 cm of the wound and she presented [sic] marshall emergency room, this was confirmed. She was referred here for admission. ¿ physical examination: ¿abdomen: rounded. The upper 2 cm of the midline incision was opened and pus is expressed from same. Cultures are taken. ¿ impression: ¿this patient has a wound infection, she has mesh in place. Unfortunately this may represent a mrsa [methicillin-resistant staphylococcus aureus]. I have obtained cultures. I began her on ancef until we have appropriate culture results. ¿ explant procedure: removal of infected abdominal mesh, placement of wound vac. Explant date: on (b)(6) 2007 [hospitalization dates on (b)(6) 2007] operative note: [no operative note from on (b)(6) 2007 related to explant was provided. ] on (b)(6) 2007: (b)(6) health. (b)(6) md. Operative report. Procedure: change of open abdominal wound vac. Pre and postoperative diagnosis: open abdominal wound. Indications: ¿a (b)(6) woman 2 days¿ status post removal of infected gore-tex mesh after a ventral hernia repair, was found to have a granulation base with a complete seal against the peritoneum and so a wound vac was placed over _____. She was brought to the operating room for the first dressing change to make sure that there was no communication with the peritoneum. ¿ procedure: ¿with the patient in the operating room after administration of iv sedation, the top sponge was removed and the abdomen prepped and draped in sterile fashion. The deep sponge was removed as was ____. This revealed good granulation tissue at the base firmly adherent around the circumference of the base with no communication with the peritoneum. A start of good granulation tissue was noted. The wound was copiously irrigated. The portion of ____ was cut and placed on the base of the wound and then 2 wound vac sponges were placed and secure adhesive sheet placed over it. The vac suction tubing was attached to the sponge which was attached the vac which then gave continuous negative pressure at 125 cm and with good retraction of the sponge. The patient was taken to the recovery room then in stable condition. ¿ on (b)(6) 2007: (b)(6) health. (b)(6) md. Discharge summary: brief preadmission history and hospital course: ¿this is a (b)(6) female who was approximately 4 weeks post ventral hernia repair with mesh who started noticing some pain and swelling along the incision site. The patient presented to marshall emergency room where a ct scan was performed which showed a seroma of the wound. There was no drainage and no signs of infection. Therefore, she was sent home. The next morning she noted purulent discharge from the upper 2 cm of the wound and presented to marshall emergency department where she was subsequently transferred to our facility. The patient was admitted to the hospital and started on iv antibiotics and wound culture was performed. The wound culture did grow out (b)(6). The patient also had local wound care performed. On (b)(6) 2007 the patient was taken to the operating room where she underwent removal of the infected abdominal mesh and placement of a wound vac with dr. (b)(6). The patient tolerated this procedure well. Postoperatively, her pain was well controlled and she was tolerating a diet. It was felt that due to the nature of the abdominal wound, it would be best to do the wound vac change in the operating room under k-mac [monitored anesthesia care] anesthesia. This was placed on (b)(6) 2007 by dr. (b)(6). The patient tolerated this procedure well. Zyvox was discontinued and bactrim was started once the culture did grow out (b)(6). Remainder of the patient¿s hospital course was uneventful. She was approved for a home wound vac and on (b)(6) 2007 was deemed ready for discharge. ¿ ¿the patient was to return for a followup [sic] visit on (b)(6) 2008 at (b)(6) with dr. (b)(6). She was set up with home nursing for abdominal wound vac change every (b)(6), (b)(6) and (b)(6). ¿ relevant medical information: on (b)(6) 2009: (b)(6). (b)(6) medicine. Office note: ¿ms. (b)(6) is in for final preparations and to discuss abdominal wall reconstruction on (b)(6). She has a large recurrent incarcerated ventral incisional hernia with loss of domain estimated at 50%. She revised the recent ct scan to stage abdominal wall components for reconstruction. She understands again the risks of the operation including of course recurrence again wound infection, bleeding and bowel injury, colostomy, major vascular injury, perioperative cardiac event, even dvt, pe [pulmonary embolism], and death. Despite the risks and the effort reconstruction, she is very motivated and interested in proceeding. I reassured her and cautioned her to quit cigarette smoking and i can sense that her husband is a cigarette smoker. He says that he has had all of this should cease around her perioperatively ¿ on (b)(6) 2009: (b)(6). (b)(6) medicine. History and physical. Diagnosis: ¿recurrent ventral hernia. ¿ history of present illness: ¿(b)(6) is a (b)(6) woman with a history of recurrent ventral incisional hernia. She has undergone 4 attempted repairs of this which have failed, the most recent one in 2007 was complicated by a gore-tex associated wound infection requiring explantation and complex wound management including vac therapy. She has been seen and evaluated by dr. Franz and a plan has been made to proceed with the above noted operation. ¿ physical exam: ¿abdomen: soft, nontender, nondistended, obese, with a thinking of the overlying skin in the mid abdominal laparotomy scar with a large bulge consistent with herniation. ¿ on (b)(6) 2010 ¿ on (b)(6)2010: (b)(6) medicine. Inpatient hospitalization. On (b)(6) 2010: (b)(6). (b)(6) medicine. Operative report. Assistant: (b)(6). Procedure: 1. Recurrent, incarcerated ventral incisional hernia repair. 2. Mesh implant (strattice). 4. Lysis of peritoneal adhesions, 1, hour. Preoperative diagnoses: 1. Recurrent, incarcerated ventral hernia. 2. Abdominal wall abbess. Postoperative diagnoses: 1. Recurrent, incarcerated ventral incisional hernia. 2. Extensive peritoneal adhesions. 3. Chronic abdominal wall abscess. Anesthesia: general. Specimens: none. Drains: three subcutaneous flat #10 channel drains. One subfascial flat channel drain. Complications: none. Indications: ¿1. Recurrent incarcerated incisional ventral hernia. 2. Abdominal wall abscess. ¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGORE® DUALMESH® BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13255735
MDR Text Key284903222
Report Number2017233-2022-02668
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/27/2012
Device Model Number1DLMC06
Device Catalogue Number1DLMC06
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2007
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: 01/13/2022 Patient Sequence Number: 1
-
-