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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 1DLMCP04
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 03/13/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2009: (b)(6) medical center. (b)(6), md. Emergency department visit. Abdominal pain right lower quadrant for one week; sudden onset. Exacerbating factors: lifting; hernia has been coming out in right lower quadrant, causing pain when lifted object at work. Long-standing hernia in this location. Abdomen: small, approximately 3 cm right lower quadrant abdominal wall hernia, not incarcerated, contents reduced easily. Impression: abdominal pain, hernia. Discharge home, good condition. (b)(6) 2009: (b)(6) medical center. (b)(6), md. Radiology ¿ ct abdomen/pelvis with contrast. Indication: abdominal/pelvic pain, nausea/vomiting. Findings: huge lower pelvic ventral hernia, initially described on (b)(6) 2005, is reidentified. Contains several loops of small bowel; all loops demonstrate abnormal inflammation of mucosa. Loops present within ventral hernia are abnormally dilated at over 3 cm in diameter and small amount of ascites present within hernia sac as well. Impression: large lower pelvic ventral hernia present as far back as (b)(6) 2005. It contains several loops of small bowel which demonstrate features of a closed loop obstruction; may be early signs of pneumatosis of one small bowel segment, worrisome for vascular compromise. Benign colonic diverticulosis. Morbid obesity, hepatomegaly, equivocal cholelithiasis. (b)(6) 2009: (b)(6) medical center. (b)(6), md. Emergency department visit. Lower abdominal pain for one day. Onset is coughing. Recent reducible hernia-coughed and increased pain; ct from urgent care. Impression: small bowel obstruction. Admit operating room. (b)(6) 2009: (b)(6) medical center. (b)(6), md. History and physical. Presenting to lmc after being evaluated at lmc-s for abdominal pain, nausea and vomiting since early this morning. Urgent care performed ct abdomen; showed incarcerated ventral hernia, possible early pneumatosis of bowel. States history of ventral hernia for last five years; not able to have repaired due to financial concerns. Having bronchitis for the last week, chills at home; on doxycycline. Nausea/vomiting improved after receiving zofran, abdominal pain improved after receiving dilaudid intravenously. Social history: quit smoking approximately one year ago; quit alcohol abuse approximately 19 years ago. Medications: metformin, doxycycline. Abdomen: obese, no bowel sounds present. Tender to palpation right lower quadrant and firm. Impression: incarcerated ventral hernia, possible early pneumatosis of bowel, recent bronchitis infection. Plan: dr. (b)(6) evaluated in emergency department, reviewed films. To operating room for exploratory laparotomy with repair of incarcerated hernia and possible resection of ischemic bowel due to early pneumatosis of bowel. Will be admitted afterwards for observation. Intravenous antibiotics to help prophylactically secure any possible bowel infection post surgery, as well as help bronchitis. Family instructed to bring all medication bottles for correct dosages. (b)(6) 2009: (b)(6) medical center. [signature illegible]. Anesthesia record. Weight: (b)(6) kg. Asa: 3 emergency. Type ii diabetes mellitus, obesity. Acute abdomen. (b)(6) 2009: (b)(6) medical center. Lab. Wbc 17. 8 h (4. 0-11. 0). Implant #1 procedure: repair of incarcerated ventral hernia with gore-tex mesh. Implant: [ni] [[ni], [ni]] implant #1 date: (b)(6) 2009 (hospitalization (b)(6) 2009). (b)(6) 2009: (b)(6) medical center. (b)(6), md. Operative report. Preoperative diagnosis(es): incarcerated ventral hernia. Postoperative diagnosis(es): same. Anesthesia: geta. Complications: none. Estimated blood loss: 100 cc. Drains: yes, 19-round jackson-pratt. Operative findings: extensive ventral hernia ¿ chronic, now with incarceration of small bowel within huge bilobed ventral hernia located in her panniculus. No evidence of strangulation of the small bowel was noted. Operation: ¿after informed consent was obtained, the patient was transported to the operating room and general et anesthesia was administered. Nasogastric tube and foley catheter were placed. The anterior abdominal wall was prepped and draped in a sterile fashion, and a vertical midline incision was placed from above the umbilicus to near the pubis. The fascia was approached very carefully and then incised in the linea alba at the supraumbilical region, and then the fascial incision was extended inferiorly methodically. The neck of the hernia was identified and carefully opened, and the bowel was brought out of the hernia sac and inspected carefully along its entire length. It was placed back into the peritoneal cavity, and portions of the hernia sac were resected. The fascia was identified around the perimeter, and multiple adhesions were taken down throughout the pelvic area. A dual side gore-tex patch was then folded down into the pelvis and brought up anteriorly and superiorly. This was tacked with fascial screw tackers from inside and then sewn with interrupted prolene sutures as well. The fascia was then closed at points of potential closure, and the subcutaneous tissue was closed with running 2-0 vicryl suture x2 and 3-0 vicryl suture x2, and stainless steel clips were utilized for skin closure. A 19-french jackson-pratt drain was brought out through a left lateral stab wound and was placed within the redundancy of the hernia sac and placed to bulb suction. Antibiotic ointment, sterile dressings, and abdominal binder were placed, and the patient was awakened from general anesthesia and transported to the recovery room in satisfactory condition. She tolerated the procedure well with no complications, and the sponge, needle, and instrument count was correct at the conclusion of the case. ¿ product identification records for the alleged gore® device were not provided. Relevant medical information: (b)(6) 2009: (b)(6) medical center. (b)(6), md. Pathology report. Accession number: (b)(4). Specimen(s): received: hernia sac. Clinical information: incarcerated hernia; possible small bowel obstruction. Gross description: received is an aggregate of pink-tan fibromembranous portions of soft tissue admixed with yellow-tan multilobulated fibrofatty tissue which is consistent with omentum. The aggregate measures 14. 0 x 10. 0 x 2. 5 cm. On section there are no masses or lesions. Representative sections are submitted in one cassette. Microscopic description: slides show fibrovascular and adipose tissue with some areas of the fibrovascular tissue demonstrating granulation-like tissue with fibroblasts and neovascularization. The mesothelial cells appear reactive. There is some papillary mesothelial hyperplasia and fibrous adhesions. No evidence of a premalignant or malignant condition is identified. Diagnostic opinion: ventral abdominal wall mass, excision: ventral hernia sac. (b)(6) 2009: (b)(6) medical center. Admission assessment. Surgical history: hysterectomy 1997. (b)(6) 2009: (b)(6) medical center. Lab. Wbc 12. 6 h (4. 0-11. 0). (b)(6) 2009: (b)(6) medical center. (b)(6), md. Discharge summary. Admission diagnoses: incarcerated ventral hernia. Possible early pneumatosis of the bowel. Hypertension. Diabetes mellitus. Recent bronchitis infection. Obesity. Discharge diagnoses: status post exploratory laparotomy with repair of incarcerated ventral hernia with dual mesh. Bronchitis, resolving. Admitted (b)(6) 2009; taken urgently to operating room. Intraoperative findings revealed extensive ventral hernia, chronic, now with incarceration of small bowel within a huge bilobed ventral hernia located in panniculus. Nasogastric tube maintained until bowel function returned. On postoperative day four, had bowel movement; diet advanced as tolerated. Jackson-pratt drain placed intraoperatively in hernia sac; output monitored daily and gradually decreased to 70 ml in 24 hours on postoperative day four. Midline abdominal incision was clean, dry, staples intact. Doing well, stable for discharge home. Of note, continued to experience productive cough from bronchitis; started on levaquin intravenously on postoperative day two. Chest x-ray grossly normal. White count on admission was 17. 8; gradually decreased to 12. 6 on day of discharge. Noted low-grade temperature on postoperative day three. Otherwise, afebrile throughout postoperative course. Hemodynamically and surgically stable at discharge. Jackson-pratt drain remains in place left lower quadrant. Home to care of family. Instructions: increase activity as tolerated with exception of heavy lifting/straining. (b)(6) 2009: (b)(6) surgical group. (b)(6), md. Office notes. Follow-up incisional hernia repair on week ago. Jackson-pratt has drained minimal amount of serosanguineous fluid; removed today. Return in one week for removal of skin clips. Wounds appear to be healing nicely with no evidence of infection. Tolerating diet. (b)(6) 2009: (b)(6) surgical group. (b)(6) md. Office notes. Follow-up incision site/staples. Complains of ¿white bellybutton¿ at incision site. Currently on doxycycline; prescribed prior to surgery for bronchitis. Continues to complain of cough that is productive with green sputum. Altered healing around belly button; noted white, 2. 8 cm long, 1. 2 cm wide. No drainage to site, no erythema around incision at bellybutton, no foul odor. Has staples all the way along midline abdominal incision; everywhere else well-approximated with no signs of infection. Abdomen soft, nontender with positive bowel sounds. Dr. (b)(6) evaluated incision site. All staples removed today; gauze dressing applied to area of altered healing at bellybutton site. Keep area clean, dry and intact, may apply gauze dressing daily. Follow-up in one week to re-evaluate altered healing site. Possibility of debridement will be discussed at that time. Instructed to contact office immediately for temperature greater than 101, erythema spreading away from incision, purulent drainage. Continue the rest of the doxycycline. (b)(6) 2010: (b)(6) medical center. Emergency department visit. Chief complaint: lower abdomen 5 days. Same as with hernia, pain increasing. Left without being seen. (b)(6) 2010: (b)(6) medical center. [signature illegible]. Anesthesia record. Weight: (b)(6) [lbs]. Asa: (b)(4). (b)(6) 2010: (b)(6) medical center. (b)(6), md. Operative report. Preoperative diagnosis(es): recurrent abdominal wall incisional hernia. Postoperative diagnosis(es): same. Procedure(s) performed: repair of recurrent abdominal wall incisional hernia with prosthetic patch. Anesthesia: general. Complications: none. Findings: lower abdominal wall midline hernia repaired with 4 x 6 inch kugel composix l/p patch. Estimated blood loss: 40 cc. Specimen: hernia sac. Drains: none. Method: after adequate general anesthetic the abdomen was prepped and draped sterilely with betadine. A midline incision was created. Sharp and cautery dissection was used in the subcutaneous tissues, identifying hernia sacs which were opened and the peritoneal cavity was entered. Hernia sacs noted emanating from the midline; however, containing small bowel and omentum projecting to bilateral lower quadrants up to the subcutaneous space bilaterally. These areas were all reduced. Hernia sacs dissected free from surrounding subcutaneous tissues. The extent of the fascial defect was defined circumferentially. This was well above the symphysis pubis inferiorly at the level of a previous patch repair superiorly and splaying of the rectus musculature noted in the lower abdominal wall midline. The defect was then completely dissected free. Hernia sac was resected. The fascial margins were grasped with kocher clamps and mattress sutures of prolene used to secure the patch circumferentially with adequate fascial overlap, restoring continuity between the 2 rectus muscles and the anterior abdominal wall fascia. The fascial defect was closed without tension circumferentially. The attenuated fascia and soft tissue were then closed in layers over the patch using pds suture, vicryl suture, and a subcuticular skin closure. Wounds were anesthetized with naropin. The patient tolerated the process well and is currently arousing from general anesthetic. ¿ (b)(6) 2010: (b)(6) medical center. Implant sticker. Bard composix l/p mesh. (b)(6) 2010: (b)(6) medical center. (b)(6), md. Pathology report. Accession number: (b)(4). Specimen(s) received: hernia sac. Clinical information: recurrent incisional hernia repair. Gross description: received are two soft, yellow, lobulated, fatty portions of soft tissue ranging in size from 2. 5 to 4. 5 cm with a small amount of attached, pink-tan, fibromembranous tissue. Also received is a 6. 0 x 4. 0 cm strip of pink-tan, fibromembranous tissue. Rs-1. Microscopic description: sections are composed of fibrovascular and adipose tissue with focal portions of mesothelial lining. Diagnostic opinion: soft tissue of abdomen, excision: consistent with hernia sac. No acute inflammation or neoplastic features seen. (b)(6) 2010: (b)(6) medical center. Discharge instructions. May shower (b)(6), wear abdominal binder. (b)(6) 2012: (b)(6) medical center. (b)(6), md. Radiology ¿ ct abdomen/pelvis with contrast. Indication: abdominal pain. Findings: supraumbilical hernia containing colon to right and slightly superior to abdominal wall mesh. Pelvic wall hernia along inferior margin of abdominal wall mesh, containing large and small bowel. Several fluid-filled loops of bowel involved, predominantly to left of midline. Hernia appears multiloculated. Impression: complex abdominal wall hernia containing several loculated pockets in a patient with previous abdominal hernia repair with mesh. Suggestion of at least partial bowel obstruction involving a loop in left lower quadrant. Additional lower series demonstrates the septated appearance to the hernia cavity. At least one dilated loop of small bowel identified with mild edema within hernia cavity. Supraumbilical hernia superior and slightly to the right of abdominal wall mesh containing transverse colon. No evidence of colon obstruction. (b)(6) 2012: (b)(6) medical center. (b)(6), md. History and physical. Seen at (b)(6) emergency room for evaluation of recurrent incarcerated ventral hernia with small bowel obstruction. Reports prior ventral hernia repair in 2009 as an incarcerated procedure. Developed recurrence and had second repair electively for symptomatic recurrent ventral hernia with mesh placement; both procedures had mesh placement; the first with gore-tex and the second with composix kugel patch. Now symptom recurrence with large hernia at low midline; present approximately past three months. Has been heavy lifting at home, developed progressive symptoms and unable to move bowels with increasing lower abdominal pain for about the past week. Could not take it anymore, came to emergency room as she does not have insurance; did not seek any other form of medical attention. Currently off all medications; no insurance to (b)(6) medications. Abdomen: soft, distended, tympanitic. Tenderness in low abdomen. Obviously amorphous appearing wide-spread fullness to lower abdominal wall from below the umbilicus down due to obesity. Hernias difficult to define. Clearly, hernias not reducible on exam. White blood cell count 13. 6, elevated blood glucose of 149. Ct scan abdomen/pelvis revealing multiple ventral hernias with one adjacent to the gore-tex mesh, which appears retracted, containing a portion of transverse colon, not obstructed; multiple sacs which are pedunculated and lobulated containing multiple loops of bowel at the low midline. A wide-mouth hernia defect is appreciated. Bowel appears somewhat dilated in areas consistent with potential closed-loop obstruction; no significant proximal small bowel distention. Impression: incarcerated recurrent ventral hernia. Plan: as has leukocytosis and significant tenderness at level of hernia site, i think appropriate to proceed in direction of emergent operative intervention. Discussed potential for future recurrence given obesity and noncompliance. Surgery will be scheduled emergently today. (b)(6) 2012: (b)(6) medical center. [signature ni]. Operative record. Asa: 2 emergency. Continued on attachment.

 
Event Description

It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2013, whereby a an alleged gore-tex dualmesh was implanted. The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: device avulsed off the left side of the abdominal wall along its entire length. Additional event specific information was not provided.

 
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Brand NameGORE DUALMESH PLUS BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11217491
MDR Text Key228832976
Report Number3003910212-2021-01148
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1DLMCP04
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/22/2021 Patient Sequence Number: 1
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