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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
Model Number 1DLMCP03
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Date 08/09/2019
Event Type  Injury  
Manufacturer Narrative
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: relevant medical information: (b)(6) 2019: (b)(6) medicine. (b)(6) md. Emergency room visit. History of type 2 diabetes mellitus, left renal angiomyolipoma status post interventional radiology embolization, meningoencephalocele complicated by cerebrospinal fluid leak status post repair presents with 1 month history of diarrhea and nonbloody emesis. Presenting today with acute worsening of abdominal pain, along with nausea/vomiting. Continues to have loose stools, non-bloody. Pain is localized to hernia site. History of cocaine abuse, in remission; diabetes mellitus with neuropathy; early syphilis, esophageal reflux; hypertension. Surgical history of gastric bypass, obese <100 cm roux-en-y, (b)(6) 2004. Current medication: insulin. Former smoker, 0. 5 packs/day, for 15 years. Quit 2018. Drug use cocaine, crack, marijuana quit 1987. Weight (b)(6) lb. , bmi 71. 18. Exam: abdomen + large ventral hernia, soft on exam, no overlying skin duskiness, abdomen mildly distended. Impression: unable to reduce hernia at bedside however skin and underlying bowel/fascia are soft. Incarcerated hernia. Plan for ct with oral contrast. (b)(6) 2019: (b)(6) medicine. (b)(6), md. Radiology-ct abdomen/pelvis. Indication: significant abdominal pain at site of known ventral hernia. Findings: small hiatal hernia. Postsurgical changes from roux-en-y gastric bypass, with significant distension of the gastric pouch with oral contrast, with minimal contrast distal to the gastrojejunostomy, which may be due to volume of bowel prep completed, timing of contrast ingestion or delayed emptying and/or motility. Approximately 15 cm segment of the mid transverse colon enters and exits the fascial defect and herniated sac. No upstream dilation to suggest obstruction. Formed and fluid stool is seen distal to this segment. Supraumbilical defect spans 4. 4 cm in maximal transverse dimension on series 3, image 223 and 5. 6 cm in craniocaudal dimension on series 5, image 69. Herniated sac spans 7. 1 x 11. 2 x 9. 1 cm in maximal dimensions. Similar to the (b)(6), 2019 ct there is mild inflammatory changes identified by mesenteric fat stranding contained within the herniated sac. A segment of nondilated mid transverse colon enters and exits the herniated sac, no findings of ischemia or obstruction. Impression: supraumbilical midline 5. 6 cm fascial defect with a 11. 2 cm herniated sac containing an approximately 15 cm segment of transverse colon. Mild inflammatory changes within the herniated sac fat. No findings of bowel obstruction or ischemia. Unchanged 8. 2 cm left upper pole renal angiomyolipoma. (b)(6) 2019: (b)(6) medicine. (b)(6), md; (b)(6), md. Consultation. Presenting with ~8 hours of symptoms from an acutely incarcerated supraumbilical ventral hernia. Reports has known she had a supraumbilical hernia for ~2 years, had always been able to reduce, had been offered surgery for repair by surgeon at (b)(6) hospital but declined at the time since it was not symptomatic. Last night, at 5 am, awoke from sleep with severe, crampy, ¿twisting¿ abdominal pain at the site of her hernia herniating to flanks. This was accompanied by nausea and several bouts of small emesis of mucousy/beige fluid. Also reports she has been belching and last passed gas 2 days ago. Exam is notable for exquisite tenderness at the site of the hernia and too much pain to able to reduce. Plan for operating room for open ventral hernia repair, possible mesh, with dr. (b)(6). Implant procedure: ventral hernia repair with underlay gore-tex dualmesh and primary fascial closure. Implant: gore® dualmesh® plus biomaterial [1dlmcp03/17708676, 1mmx10cmx15cm]. Implant date: (b)(6), 2019 (hospitalization may (b)(6), 2019) (b)(6), 2019: (b)(6) medicine. (b)(6), md. Operative report. Preoperative diagnosis: incarcerated ventral hernia. Postoperative diagnosis: incarcerated ventral hernia. Assistant: (b)(6), md. Anesthesia: gen. Endotracheal. Estimated blood loss: minimal. Complications: none. Specimens: hernia sac to pathology. Note: the rationale, technical aspects, risks, and benefits of the procedure were discussed on detail with the patient, from whom free informed consent was obtained to proceed. This informed consent was obtained directly by me, the attending physician performing the procedure. Indications for the procedure: constance gilmore is a (b)(6) year old female who presented to the emergency department with acute epigastric pain in the region of her known hernia. She states the hernia has been present for over 2 years but acutely became tender today to the degree that she could not tolerate the pain. She had a cat scan of the abdomen revealed incarcerated bowel. She was scheduled for this emergent surgery. Details of the procedure: ¿the patient was taken to the operating room and identified by both name and medical record number. The patient was transferred to the operating room table. Gen. Endotracheal anesthesia was initiated without incident. The patient was then placed into the supine position with all of the appropriate padding and protection. The patient¿s abdomen was prepped and draped in the usual sterile fashion. After appropriate surgical timeout surgery was begun. A 10 cm midline incision was created just above the umbilicus. The subcutaneous tissues were dissected with electrocautery and we approached the hernia sac. We were able to reduce the contents of the hernia at this time. At the level of the true fascia we incised the hernia sac circumferentially excised the hernia sac at this level. The hernia sac was sent to pathology for further evaluation. From within the abdomen there were no other palpable defect in the abdominal wall. The previously incarcerated contents were quite viable and normal in appearance. We therefore decided to place a piece of mesh to reinforce our surgical repair. A 10 x 15 cm piece of gore-tex dualmesh was selected. We did create flaps just above the fascia in order to tack the mesh circumferentially 5 cm from the edge of the defect. We then placed the mesh in the appropriate orientation into the abdomen and tacked it circumferentially with #1 prolene suture using a series of u sutures. The mesh laid taut and appropriately took the tension off the midline fascia. We then closed the midline fascia with another running #1 prolene suture. The wound was hemostatic. We copiously irrigated and suctioned dry. We did place a jp drain through a separate stab incision as the subcutaneous space that was previously occupied by the hernia was large. We then closed the subcutaneous space in layers of 3-0 vicryl. We also likely close the skin with a 4-0 biosyn. Sterile dressings were applied. The patient tolerated the procedure well and was taken to the pacu in stable condition. I was present for and participated in all portions of this procedure. ¿ (b)(6) 2019: (b)(6) medicine. Implant record. Inventory item: ptch dl 1mmx10cmx15cm. Serial number: (b)(4). Model/cat number: 1dlmcp03. Manufacturer: wl gore associates. Exp. Date: 10/31/2020. Number implanted: 1. The records confirm a gore® dualmesh® plus biomaterial (1dlmcp03/ (b)(4)) was implanted during the procedure. Relevant medical information: (b)(6) 2019: (b)(6) medicine. (b)(6), md. Pathology. Final diagnosis: 1) hernia sac, repair: mesothelial-lined fibroadipose tissue, consistent with hernia sac. Gross description: the case is received in on formalin filled container, labeled with patient¿s name and medical record number. Specimen 1 is designated ¿hernia sac¿ and consists of a 5. 3 x 4. 7 x 2. 3 cm pouchlike fibrous tissue fragment. The inner lining and external surface are pink-tan smooth to slightly trabeculated. Sectioning shows the thickness from less than 0. 1-0. 5 cm, embedded with yellow lobular adipose tissue. Representative sections are submitted in one cassette 1a. (b)(6) 2019: (b)(6) medicine. (b)(6) , pa-c; (b)(6) , md. Discharge summary. Admission date: (b)(6) 2019. Discharge disposition: the patient was discharge to home in good condition. Hospital course: history of morbid obesity (bmi 71) status post lap rygb in 2004, also status post exploratory laparotomy x2 for ectopic pregnancies (in 1990s via pfannenstiel) who presented to the hup emergency department on 5/02/19 with abdominal pain. Of note, patient has had a known supraumbilical hernia for ~2 years which has been reducible. Prior to presentation to hup emergency department had been seen in the ppmc emergency department on (b)(6) 2019 for crampy abdominal pain, diarrhea, and emesis with associated hypotension and dehydration. Ct a/p demonstrated ventral hernia without evidence of incarceration or strangulation. She was found to have a urinary tract infection and vaginal candidiasis and was discharge home with appropriate antimicrobials as well as dicyclomine and zofran for her gastrointestinal symptoms. In the hup emergency department, was afebrile, vital signs stable with unremarkable labs. Ct a/p demonstrated ventral hernia slightly enlarged (measured 4. 8 cm transverse x 3. 5 cm craniocaudal) containing a loop of colon. Ess was consulted and she was admitted to their service for further management. On (b)(6) 2019, was taken to the operating room and underwent ventral hernia repair with underlay goretex dualmesh and primary facial closure. Tolerated the procedure well and was transferred back to the floor in stable condition. A jp drain was left in the subq space. She voided appropriately post-operatively. She was given a clear liquid diet and oral medications for pain control. Diet was gradually advanced, ivf discontinued, and her pain remained well controlled. Was ambulating without difficulty. Remained afebrile, vital signs stable and was deemed stable to discharge to home on (b)(6) 2019. Was arranged for home visiting nurse to assist with wound and jp drain care. At the time of discharge the patient had stable vital signs, was ambulating independently, was tolerating a regular diet, had bowel and bladder function and pain was well controlled with oral medications. Weight (b)(6) lb, bmi 71. 18. (b)(6) 2019: penn medicine. (b)(6) , crnp. Office notes. Presents for 4 day follow up since (b)(6) visit for (b)(6) aching abdominal pain since surgery, now pain is 12/10. In past 2 days, increased significantly and feels sharp pain. At friday¿s discussion, planned to wear binder, increase laxatives, miralax and senna; she decided only to take stool softener because appetite was lower. Took dicyclomine that she had at home; did not help, pain worse. Past 2 days is dizzy when she stands. Denies fever, vomiting; chills this weekend. Normal bowel movement this morning, is passing gas. Wt. (b)(6) lbs. , bmi 37. 28. Abdomen: soft, bowel sounds normal, no distention. Tenderness umbilical area and right of umbilical area; pain to light palpation, no redness or warmth. There is guarding. Follow-up: return in about 2 days (around (b)(6) 2019) for after emergency department visit. Impression/plan: lower abdominal pain, dizziness, status post repair of ventral hernia. Pain has doubled since friday, tearful with pain today; agrees to go directly to ed for evaluation, ct and recheck cbc. (b)(6) 2019: (b)(6) medicine. (b)(6), md. Radiology-abdomen/pelvis. Indication: abdominal pain. Status post ventral hernia repair on (b)(6) 2019. Findings: postsurgical changes of ventral hernia repair with anterior abdominal wall mesh. There is loculated fluid with mild rim enhancement in the anterior abdominal wall subcutaneous tissues measuring approximately 2. 7 x 5. 0 x 4. 8 cm, with some surrounding fat stranding/fluid from recent surgery. No gas is seen within the fluid collection. Impression: postsurgical changes of ventral hernia repair and mesh placement. There is a small amount of fluid in the subcutaneous soft tissues extending from the hernia repair mesh to the skin surface along the surgical incision. Although this fluid may be postsurgical seroma, superimposed infection is not excluded. Clinical correlation is recommended. (b)(6) 2019: (b)(6) medicine. (b)(6), md. Operative report. Procedure: ultrasound-guided abscess drain placement. Complications: none. Contrast: none. Physicians: neil harrison, md; scott trerotola, md. Findings: successful drain placement into anterior abdominal wall collection. 25 ml of blood-tinged pus removed, with a sample sent for analysis. Plan: keep to gravity drainage. Flush with 10 ml of normal saline daily. Record output every shift. Ir will follow with you. (b)(6) 2019: (b)(6) medicine. (b)(6), pa-c. Discharge summary. Past medical history of hypertension, hyperlipidemia, anxiety, depression, sickle cell trait, morbid obesity with roux-en-y 2004, ex lap secondary to ectopic pregnancy 1994, lumbar stenosis with chronic pain, intestinal disaccharide malabsorption, abdominal pain status post hernia repair on (b)(6) 2019 with jp drain (since removed, abdominal binder, healing well) that presents with ongoing abdominal pain at the incision site, radiating to right side of abdomen. Was seen by her primary care provider 4 days ago for this discomfort. Re-presented again yesterday with worsening pain, and thus was referred to the emergency department for further evaluation. In the emergency department, labs were drawn. Ct of the abdomen and pelvis was performed which was significant for a small amount of fluid in the subcutaneous tissue along the surgical incision representing a possible seroma. On (b)(6) 2019, successfully underwent interventional radiology drainage of the seroma. Was given a dosage of antibiotics. Pain improved. Was able to tolerate oral. The patient is to continue to allow the tube to drain to gravity. Is to flush the tube daily with 10 ml of normal saline. Drain teaching was provided. Surgery recommended that the patient be discharged on bactrim x 7 days. (b)(6) 2019: (b)(6) medicine. (b)(6), md. Office notes. Hernia repair (b)(6) 2019 complicated by seroma; presents to acute and transitional gastroenterology clinic for evaluation of constipation. For past few months, has had bowel movements daily or every other day with intermittent stool softeners as needed. Has not had bowel movement in 5 days. I suspect this is due to recent procedures and medications (morphine and oxycodone). Has taken miralax twice, stool softeners, colace, senna, with no results. Is passing flatus. Colonoscopy was unrevealing in (b)(6) 2018. No abdominal pain today. Per patient, had ulcer 4-5 years ago; takes a ppi. Does not recall etiology. Reported 1 dark bowel movement, but in setting of constipation, little concern for gi bleeding. No nausea/vomiting. Wean ppi to every other day, check cbc, obtain records and consider egd next visit. Return in about 3 months, stop taking stool softeners, colace and senna. Take miralax 3 times/day for 3 days then increase/decrease as needed, hydration with water, prune juice trial, increase dietary fiber. (b)(6) 2019: (b)(6) medicine. (b)(6), md. Radiology-ct abdomen/pelvis. Indication: status post repair of ventral hernia. Findings: post-surgical changes from supraumbilical herniorrhaphy with mesh. No findings of mesh migration or disruption as it is in the same configuration. Gaps along the superior and inferior margins of the mesh to the tacking of the fascia is unchanged, heterogenicity in the subcutaneous fat makes it impossible to determine if there is integrity of the repaired fascia. No findings of reaccumulation of the previously seen collection. No subcutaneous air. Impression: ventral herniorrhaphy: continued heterogeneity in the subcutaneous fat along the incision could represent ongoing cellulitis/infection but no findings of reaccumulation of fluid/abscess. (b)(6) 2019: (b)(6) medicine. (b)(6). Email to (b)(6), crnp. I saw the trauma surgeon again today. We are planning the next surgery for (b)(6) 2019. I am much afraid because we are not sure what is causing my pain. The one thing they can think of is the hernia mesh is infected. The hernia feels much better since i had the mesh. The pain i had prior to the hernia surgery is still there. I hate to lose the mesh. Is there another specialist i can see you can perform other test to see what is going on in my belly? i was told that the pain could return after the mesh is removed, then the mesh would have been removed for no reason. It is the same pain i had prior to the hernia surgery. Should i go to (b)(6) hospital? what do i need to do? (b)(6) 2019: (b)(6) medicine. (b)(6). Email to (b)(6), md. I am thinking much about the surgery. Most times during the day it is unbearable, but i keep moving. Prior to the hernia surgery, i had this pain in my stomach. After the hernia surgery, i felt better and could tell the hernia had been repaired; however, the pain remained. Then there was the infection (not sure where it came from). To perform another surgery and take the mesh away and the pain remains frightens me. Are there other alternatives? can we do a biopsy underneath the skin and test the muscle. When my muscles contract, this causes the pain to flair up. This pain originated after i did a colonoscopy in (b)(6) 2018. I was in the emergency room a week later believing i had bad gas. It wasn¿t; they noticed the hernia. (b)(6) 2019: (b)(6) medicine. (b)(6), md. Office visit. Presents to emergency surgery service clinic for constant abdominal pain status post ventral hernia repair with goretex mesh (b)(6) 2019. Since hernia repair, continued to have abdominal pain; prompted her to present to primary care physician then subsequently the emergency department on (b)(6) 2019 where imaging showed fluid collection above the mesh. Interventional radiology placed drain, put on bactrim for antibiotic coverage. On (b)(6), abscessogram showed collection improvement; drain removed. Returned to clinic 6/25 for postoperative visit with no complaints. On (b)(6), presented to primary care physician with return of abdominal pain, notably in area of old drain placement (left of umbilicus) and sometimes to right of umbilicus as well. Sent for ct scan. Abdominal pain has not improved; describes it as stinging pain. Denies nausea/vomiting, fever, chills. Pain constant, but worsened by movement, laying on stomach. Abdominal binder, cold packs help with the pain. Started on antibiotics last clinic visit; this did not resolve pain in any way. She says at her previous soft tissue skin infection after hernia repair, there were no skin changes despite the fact she required drainage; does not have skin changes now. Most recent ct scan shows stranding in the subcutaneous tissue but no obvious drainable collection. Wt. (b)(6) lbs. , bmi 36. 14. Impression: with multiple abdominal surgeries and recent ventral hernia repair with goretex mesh who presents with continued pain over incision site. Given symptoms and ct findings, this is likely an unresolved mesh infection. Spent quite a bit of time speaking with her regarding risks, benefits, alternatives of mass [sic] explantation. Said she does not have insurance until after august 1st and would like to wait until that time to have mesh explanted. Plan: excision of existing mesh early august. Agrees to proceed. (b)(6) 2019: (b)(6) medicine. (b)(4), md. Pre-anesthesia note. Medical history: obesity class ii (bmi 35-39. 9), insulin dependent diabetes, daily nausea/vomiting. Asa status: 3. Explant procedure: excision of infected hernia repair mesh. Repair of recurrent ventral hernia, implantation of onlay phasix biosynthetic mesh, intermediate closure of abdominal incision 25 cm in length. Explant date: (b)(6) 2019 (hospitalization (b)(6) 2019). (b)(6) 2019: (b)(6) medicine. (b)(6), md. Operative report. Preoperative diagnosis: infected hernia mesh. Postoperative diagnosis: as above. Anesthesia: general endotracheal. Assistant: phillip dowzicky, md. Estimated blood loss: minimal. Specimens: specimen for gram stain. Drains: 1 blake drain in the retromuscular space in the abdominal wall. Complications: none. Condition: stable. Indications for procedure: this is an unfortunate (b)(6) year old female who presented to clinic with abdominal pain after an [sic] hernia repair with mesh. She had a ct scan which demonstrated stranding around the mesh. She went and saw another surgeon for 2nd opinion, who also recommended excision of the mesh. He also recommended that plastic surgery be involved in the excision, and so we consulted dr. (b)(6) from plastic surgery. I would perform the excision of the mesh, and he would perform the reconstruction of the abdominal wall. After a thorough discussion of the risks and benefits of the procedure, informed consent was obtained. Description of procedure: the patient was brought from the holding area to the operating room and placed in the supine position. After successful induction of general endotracheal anesthesia, patient¿s abdomen was then prepped and draped in the standard surgical fashion. A surgical time out was then performed and the patient was positively identified using two identifiers. Preoperative antibiotics were administered. We then made a vertical midline laparotomy incision through a previous incision. This was carried down through the skin and subcutaneous tissue using the bovie electrocautery. The fascia of the anterior rectus sheath was divided using bovie electrocautery. At this point we were able to detect that there was a fair amount of edema in the tissue, consistent with an ongoing infection. Once we opened the rectus sheath we were able to visualize the mesh, which was a gore-tex mesh. It was not well incorporated, and beneath it we found a pocket of pus. This was sent for gram stain and then evacuated. We then cut the retaining sutures to the mesh, taking great care to retrieve the sutures and the knots as these were prolene. Once we had completed our excision, we call plastics the room. They performed the remainder of the case, including closure of the defect an onlay mesh repair. This will be dictated in a separate op note. The patient tolerated the procedure well. There were no intraoperative complications. I was present and scrubbed for the entire duration of my portion of the procedure. All sponge and needle counts were correct at the end of my portion of the case. ¿ (b)(6) 2019: (b)(6) medicine. (b)(6), md. Operative report. Preoperative diagnosis: recurrent ventral hernia, infected mesh of abdomen. Postoperative diagnosis: recurrent ventral hernia, infected mesh of abdomen. Anesthesia: general endotracheal anesthesia. Indications for procedure: the patient is a female with a past medical history significant for previous ventral hernia repair. She has now developed a chronic mesh infection of her anterior abdominal wall. I saw the patient and discussed the approach to this chronic mesh infection of her abdominal wall. We discussed the need for removal of all chronically infected synthetic mesh in its entirety, as well as the means to provide for a durable recurrent hernia repair. We discussed the different types of mesh that are available including the mesh that will be compatible with a contaminated field. We discussed biosynthetic mesh in particular, and we discussed the different anatomic planes of mesh placement, our ability to achieve myofascial autologous abdominal wall closure, and the degree of contamination, all affecting her risk of hernia recurrence. The patient understood her risks and benefits of the anticipated surgery and wished to proceed. Description of procedure: ¿the patient was identified in the holding area, and the operative procedure was reviewed with the patient in detail. The patient was then taken to the operating room and placed supine on the table. After induction of general endotracheal anesthesia, the patient¿s abdomen was then prepped and draped in the standard surgical fashion. Attention was then turned to the patient¿s abdomen by the general surgical service, who then performed the patient¿s formal opening incision, as well as removal of the infected prosthetic mesh. For details of their operative procedure, please see the separately dictated operative note. The plastic surgical service then entered the room. The defect was examined. The patient was noted to have recurrent ventral defect in the midline, which measured 12 x 8 cm. Of note, there was no plane underneath the abdominal wall secondary to a visceral block underneath the chronically infected mesh. However, her autologous myofascial abdominal wall could be brought together primarily in the midline. Secondary to the inability secondary to the risk of developing a retromuscular plane, the decision was then made to perform a formal primary closure with biosynthetic mesh onlay reinforcement of this recurrent ventral defect. Towards that end, the patient¿s abdominal wall was irrigated copiously, noted to be hemostatic. The midline fascia was then closed primarily with interrupted #1 maxon figure-of-eight sutures. A piece of phasix biosynthetic mesh was then cut to the appropriate size and placed in the onlay position. This was done by first placing a simple #1 maxon suture superiorly, and then along the patient¿s right side. This was then tensioned across midline and inset to the left side by tensioning the mesh and de-tensioning this midline fascial closure. This was also accomplished with interrupted #1 maxon sutures. The midline mesh was then imbricated down to the primary fascial closure with interrupted #1 maxon sutures as well. Attention was then turned to the remainder of abdominal wall, which was hemostatic. A drain was placed. The skin edge was then excised sharply back to healthy bleeding skin edge and hemostasis was once again achieved with the bovie cautery. The resultant 25 cm midline abdominal incision was then closed in a meticulous and intermediate fashion. This consisted of interrupted 0 vicryl sutures to reapproximate scarpa¿s fascia, interrupted 3-0 vicryl sutures to reapproximate the intermediate tissue, and ultimately a running quill subcuticular suture to reapproximate skin. Dressings were applied. The patient tolerated this procedure well. The patient was then awoken from anesthesia, extubated, and taken to the recovery room in stable condition. I was present for the critical portions of this operative procedure and immediately available at all times. ¿ (b)(6) 2019: (b)(6) medicine. Implant record. Inventory item: mesh hrna repair 10cmx15cm. Manufacturer: cr bard. Relevant medical information: (b)(6) 2019: (b)(6) medicine. (b)(6), md. Pathology. Accession: hs-19-0026611. Final diagnosis: 1) mesh, removal: medical device consistent with mesh material, gross examination only. Gross description: the case is received in one container, labeled with the patient¿s name and medical record number. Specimen 1 designated as ¿resected mesh¿ and consists of a 11. 3 x 7. 3 x 0. 2 cm tan-pink soft flexible synthetic surgical material consistent with an explanted synthetic surgical mesh. Gross photos are taken, no sections submitted. Clinical information: constant abdominal pain status post thr repair with gore-tex mesh (b)(6) 2019. Operation: repair incisional/ventral hernia. Specimen: resected mesh. (b)(6) 2019: uphs cernmill laboratory. Microbiology. Swab-peri prosthetic mesh, abdomen. Routine culture: rare staphylococcus aureus. Gram stain: no bacteria seen. Few polymorphonuclear leukocytes. Organism: staph aureus. Anaerobic culture: no anaerobic organisms isolated. Fungus culture: no fungus isolated in 2 weeks. Afb stain & culture: no mycobacteria isolated in 6 weeks. No afb seen by fluorochrome stain. (b)(6) 2019: (b)(6) medicine. (b)(6), student; (b)(6), md. Progress notes. Presented with abdominal pain after hernia repair with mesh. Ct scan demonstrated stranding around mesh. Saw another surgeon for 2nd opinion, who also recommended excision of mesh. Also recommended plastic surgery be involved in the excision. She is status post mesh explantation with primary fascial closure with biphasix overlay (b)(6). Doing well. Appropriate pain near incision site, has not gotten out of bed. Midline incision clean/dry/intact, jp in place with serosanguinous output, no erythema or tenderness surrounding drain site. Attestation: saw/evaluated patient. Agree with history, exam, and medical decision making with following additions/exceptions/observations: status post excision of infected mesh and hernia repair with plastics. Postoperative day 1, doing well. Advance diet as tolerated. Discontinue epidural when okay with pain team, continue jackson-pratt in rectus sheath, bactrim for possible mesh infection for 72 hours ¿ gram stain from operating room negative, but did appear to have pus around mesh. (b)(6) 2019: (b)(6) medicine. (b)(6), crnp; (b)(6), md. Discharge summary. Diagnosis: abdominal hernia. Discharged home in good condition. Follow-up (b)(6) 2019 with (b)(6), rn; (b)(6) 2019 with (b)(6), pa-c; (b)(6) 2019 with (b)(6), crnp. Hospital course: (b)(6) year-old who presents for elective mesh excision and closure. Presented to ess clinic on (b)(6) for persistent abdominal pain after primary care physician sent her for a ct scan. Ct revealed heterogeneity in the subcutaneous fat along the incision consistent with possible infection but no fluid re-accumulation. Started on antibiotics and scheduled for surgical excision of mesh. Presented on (b)(6) and proceeded for excision of gortex mesh and repair of ventral hernia with phasix onlay, primary skin closure (plastics). Taken to surgical floor in stable condition. Epidural placed prior to procedure for pain control. On postoperative day 1, foley removed and voiding without issue. Given regular diet; tolerated without issue. Epidural removed (b)(6). Pain well-controlled with oral pain medications. On (b)(6), deemed stable for discharge home. At time of discharge had stable vital signs, was ambulating independently, tolerating regular diet, had regular bowel and bladder function and pain was well controlled with oral medications. Operative procedures: (b)(6) 2019: gortex mesh excision, ventral hernia repair with onlay. Wt. (b)(6) lbs. , bmi 36. 7. Medication: start taking amoxicillin-clavulanate for 7 days, oxycodone as needed; continue novolog insulin, semaglutide, insulin glargine; stop fluconazole. (b)(6) 2019: (b)(6) medicine. After visit summary. Resolved: abdominal hernia. Activity: as tolerated, may shower, do not lift more than 10 lbs. Regular diet. Follow up with emergency surgery service in 1-2 weeks. Dr. (b)(6) in plastic surgery (b)(6), primary care physician within 2-3 weeks. Resources arranged: home care-nursing, medication management, disease management. Jp drains to bulb suction; record outputs.
 
Event Description
It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2019 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2019, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: removal of gore mesh due to failed mesh and pain, recurrent ventral hernia repaired with new mesh. 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
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12182173
MDR Text Key267258032
Report Number3003910212-2021-01262
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K063435
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 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model Number1DLMCP03
Device Catalogue Number1DLMCP03
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2017
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: 07/16/2021 Patient Sequence Number: 1
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