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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 1DLMCP07
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 02/04/2019
Event Type  Injury  
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: (b)(6) hospital. On (b)(6) 2005: (b)(6) hospital. No provider listed. Radiology: ct abdomen and pelvis without iv contrast. Indication: ¿right upper quadrant abdominal pain. ¿ impression: ¿right lateral abdominal wall hernia without evidence of obstruction. Small fat containing ventral hernia. Right middle lobe and lingular scarring with mild bronchiectasis. ¿ on (b)(6) 2005: (b)(6) hospital. No provider listed. Radiology: xr chest pa [posterior-anterior] and lateral: impression: ¿no radiographic findings of acute cardiopulmonary disease. ¿ on (b)(6) 2005: (b)(6) hospital. (b)(6), md. Upper gi [gastrointestinal] endoscopy. Impression: ¿normal duodenum, stomach, and esophagus. Irregular scj [squamocolumnar junction ¿z-line¿]. ¿ on b)(6) 2005: (b)(6) hospital. (b)(6), md. Discharge notes. Diagnosis: ¿acute on chronic epigastric pain. ¿ followup [sic]: ¿with dr. (b)(6) on (b)(6) 2005. ¿ hospital course: ¿the patient was admitted from dr. Johnson¿s office with a four-day history of worsening epigastric pain. She had some blood-tinged vomiting for a few days prior. On admission, she was made n. P. O. [nothing by mouth] and given intravenous fluids with a ct scan of the abdomen and pelvis unremarkable. Otherwise, her examination was unremarkable including a heme-negative rectal examination. She did have a dilutional drop in her hemoglobin, however, this was stable over the 48 hours. She did undergo esophagogastroduodenoscopy [egd] by gastroenterology, which was completely unremarkable per verbal report (written report pending). She was comfortable with going home and will call dr. Johnson¿s office with any further questions or concerns. She will follow up with dr. (b)(6) for probably ct enteroclysis. ¿ on (b)(6) 2005: (b)(6). No provider listed. Radiology: us abdomen complete. On (b)(6) 2005: (b)(6) hospital. No provider listed. Radiology: xr abdomen kub [kidney ureter bladder]: impression: ¿non-obstructive bowel gas pattern. ¿ on (b)(6) 2005: (b)(6). No provider listed. Radiology: right upper quadrant ultrasound: impressions: ¿normal right upper quadrant ultrasound. Tail of pancreas not visualized. ¿ on (b)(6) 2006: (b)(6). No provider listed. Radiology: ct enteroclysis without iv contrast: clinical indication: abdominal pain, history of multiple abdominal surgeries, evaluate for hernia, small bowel obstruction and adhesions. Impression: no evidence of mechanical small bowel or colonic obstruction. No significant parietal, peritoneal or visceral adhesions involving small intestine. Marked thinning of right anterior and lateral abdominal wall muscles extending inferiorly but without evidence of fascial defect or bowel herniation. ¿ implant preoperative complaints: on (b)(6) 2006: (b)(6). (b)(6). Preoperative diagnosis: ¿incisional hernia without mention of obstruction or gangrene. ¿ on (b)(6) 2006: (b)(6). (b)(6), history of present illness: ¿the patient is a (b)(6) obese female who has past medical history significant for an automobile accident in 1988 who presents with ventral and flank hernias. She is symptomatic with these hernias with abdominal pain. At the time of the automobile accident in 1988, the patient underwent an exploratory laparotomy with resection of small bowel. She had previous hernia repair secondary to this exploratory laparotomy with mesh approximately 1-2 months later. In the past several months, the patient has experienced several episodes of abdominal discomfort and had an episode of small bowel obstruction in (b)(6) 2005 that was treated conservatively at st. Vincent's hospital. A ct scan with oral contrast has confirmed evidence of these hernias with no current obvious obstruction, however, her abdominal pain continues. She has no nausea or vomiting currently, although she does have some constipation for which she uses an enema. The patient was seen in clinic preoperatively. The risks, benefits and alternatives of surgery were discussed and informed consent was obtained. ¿ implant procedure: laparoscopic ventral hernia repair with gore-tex dualmesh plus (28 x 17 cm). Left subclavian triple lumen central catheter placement. [implant: gore® dualmesh® plus biomaterial, 1dlmcp07 /(b)(4), 20cm x 30cm x1mm thick] implant date: on (b)(6) 2006 [hospitalization dates: on (b)(6) 2006] wound classification: ¿clean. ¿ on (b)(6) 2006: (b)(6). (b)(6). Postop diagnosis: recurrent ventral/flank hernia. Procedure: laparoscopic ventral hernia repair with goretex [sic] dualmesh plus (28x 17 cm mesh). Complications: none. Estimated blood loss: 20 ml. Assistant: (b)(6). [full operative report was not provided] (b)(6) 2006: (b)(6). Implant record: patch soft tissue 20 x 30 x1, lot: 03851108, manufacturer: gore, catalog #: 1dlmcp07. On (b)(6) 2006 (b)(6). Radiology: xr [x-ray] chest pa [posterior-anterior] and lateral: ¿impression: no acute cardiopulmonary process. Xr abdomen kub [kidney ureter bladder] and upright: impression: status post right hernia repair with nonobstructive bowel gas pattern. ¿ on (b)(6) 2006: us [ultrasound] guided fluid aspiration. On (b)(6) 2006: (b)(6). (b)(6). Discharge note: hospital course: ¿the patient was admitted to the university hospital on (b)(6) 2005 [discrepancy 06] at which time she was taken to the operating room and underwent a laparoscopic ventral hernia repair with gore-tex dualmesh plus for recurrent ventral/flank hernia. The patient tolerated the procedure well, but had a significant issues with pain control and i. V. Catheter placement. On (b)(6) 2006, a central line was placed in the patient¿s left subclavian vein for administration of i. V. Pain medications and for i. V. Access. It was felt that the i. V. Access was difficult due to her obesity¿on the 6th day postoperative day the patient was doing well. She had been weaned from her intravenous pain medication and had better pain control with oral pain medications. She was ambulating and eating without difficulty. The triple lumen catheter was removed. The patient was sent home. Discharge diagnoses: recurrent ventral hernia status post laparoscopic ventral hernia repair. Diabetes mellitus. ¿ instructions: ¿she should not lift anything more than 10 pounds for at least 6 weeks. Followup: the patient should follow up with dr. (b)(6) in 4-6 weeks. ¿ relevant medical information: on (b)(6) 2006: (b)(6). (b)(6), md. Emergency medicine service. ¿(b)(6) c/o [complains of] light-headiness, dizziness, abdominal pain. She then awoke on the floor. She called dr. (b)(6), recommended that she come the ed [emergency department]. She also had 2 episodes of vomiting. Denies possibility of pregnancy, denies sexual active. She has otherwise been well except for her reactive airway disease. Physical exam: abdomen: tenderness on right upper quadrant, no rebound or guarding. Impression: syncope, abdominal pain, chest pain, vertigo. Plan: admit. ¿ on (b)(6) 2006: (b)(6). (b)(6), md. Radiology-ultrasound: us [ultrasound] guided fluid aspiration. Indication: status post laparoscopic ventral hernia repair, large surrounding fluid collection around the mesh. Findings: after obtaining informed consent, the patient¿s right lateral abdomen was prepped and draped in a sterile fashion. 10 cc of buffered 1% lidocaine with epinephrine was administered for local anesthesia. Using ultrasound guidance, an 18 gauge trocar needles was inserted into a 15. 2 x 7. 5 cm oval shaped multiseptated fluid collection within the prior surgical site. 200 cc of dark brown fluid was aspirated. There were no complications. Dr. (b)(6) was present for the entire procedure. The fluid was sent to the laboratory for analysis. Impression: successful ultrasound guided fluid aspiration of a large fluid collection within the right abdominal wall mesh. ¿ on (b)(6) 2006: (b)(6). Physician not provided. Radiology: ct abdomen and pelvis with iv contrast. Impression: ¿1. 6. 5 x 11. 9 cm fluid collection with peripheral enhancement in right posterolateral abdominal wall hernia mesh. This likely represents a seroma. Peripheral enhancement may be due to inflammation related to surgical procedure or infection. 2. Probably uterine leiomyoma. ¿ on (b)(6) 2007: (b)(6). (b)(6), md. Colonoscopy. Indications: ¿epigastric and infraumbilical abdominal pain of several years duration with no alterations in the bowel habits. Impression: mild sigmoid diverticulosis. Otherwise, normal colonoscopy upto [sic] the terminal ileum. ¿ upper gi [gastrointestinal] endoscopy. Impression: ¿z-line irregular, 41 cm from the incisors. Otherwise normal egd [esophagogastroduodenoscopy]. ¿ on (b)(6) 2007: (b)(6). Emergency medicine visit. On (b)(6) 2007: (b)(6). (b)(6), md. Emergency medicine. ¿6 weeks of upper abdominal pain [illegible] diarrhea and intermittent vomiting when she eats [illegible] different than chronic abdominal pain. Physical exam: obese, [illegible] abdomen soft, nd [non-distended], c/o [complains of] mild sensitivity to palpation, guard of right. Impression: hypokalemia. ¿ on (b)(6) 2007: (b)(6). [md signature illegible]. History/physical: ¿(b)(6) female who present with abdominal pain ¿ epigastric with nausea/vomiting/diarrhea over past 2-3 days. Previously had chronic abd pain in the epigastric for six weeks. Had undergone multiple repairs of hernia and seroma drainage. Also had been seen in pain clinic for chronic abd pain. Ct ¿ no evidence of obstruction or cause of pain. ¿ on (b)(6) 2007: (b)(6). Provider not listed. Radiology: ct abdomen and pelvis with iv contrast. Impressions: ¿ interval decrease in size of right posterolateral extraperitoneal fluid collection adjacent to surgical mesh material. Nonobstructive 2 mm left renal stone. Heterogeneously enhancing myometrial mass lesions most likely representing uterine fibroids. Persistent scarring and/or subsegmental atelectasis within the middle lobe and lingula. ¿ on (b)(6) 2007: (b)(6). (b)(6) rn. Emergency medicine. Visit reason: ¿abdominal pain. Discharge information: follow up with primary care provider. ¿work up tonight shows no obvious cause for your symptoms you have been seen by the surgery team who would like you to contact the pain clinic for follow up. ¿ on (b)(6) 2007: (b)(6). Provider not listed. Radiology: hepatobiliary imaging including measurement of gall bladder ejection fraction. Indication: ¿chronic epigastric pain that worsens with feeding. Question biliary dyskinesia. ¿ impression: ¿the examination is normal. There is no evidence of acute cholecystitis or extrahepatic obstruction. The gallbladder responds normally to cck intervention and shows an ejection fraction of 95 %. ¿ on (b)(6) 2007: (b)(6). (b)(6), md. Emergency medicine: visit reason: abdominal pain. ¿(b)(6) female who presents with 24-76 hours of n/v [nausea/vomiting] and abdominal cramping. Diffuse/intermittent cramping. No fever, no blood in stool. Recent hida [hepatobiliary iminodiacetic acid] scan negative. Physical exam: abdomen soft, mild distention, no g/r [guarding or rebound tenderness]. Plan: discharge home with phenergan and motrin. Impression: vomiting, abdominal pain acute. ¿ on (b)(6) 2018: (b)(6). (b)(6) md. General surgery consult note: history of present illness: ¿(b)(6) female with an extensive surgical history who presents to clinic today for umbilical hernia. Patient was referred by dr. (b)(6). Patient had a trauma ex lap [exploratory laparotomy] following mvc [motor vehicle crash] in (b)(6) in 1990¿s. Patient had then developed lateral abdominal hernia which was repaired by dr. (b)(6) with mesh in 2004. Patient has had ongoing pain related to prior repair and seroma. She states pain is (b)(6) and restricts daily activity. Ct abd/pelvis was obtained right lateral body wall hernia repair with mesh, moderate extraperitoneal seroma and periumbilical hernia. Patient is here for potential surgical management. Physical examination: gastrointestinal: soft. Mildly tender to palpation on right. Nondistended. Umbilical hernia. Numerous surgical scars. Impression and plan: (b)(6) lady with extensive medical history with umbilical hernia and seroma. Ct scan reviewed in clinic, reveals small umbilical hernia and moderate seroma. Refer to dr. Reed for potential abdominal wall reconstruction. ¿ on (b)(6) 2018: (b)(6). (b)(6), md. Clinic office records. Chief complaint: ¿recurrent hernias, retained mesh with seroma. History of present illness: ¿i saw (b)(6) in the clinic today. She is a (b)(6) female who developed a hernia of her right flank from a motor vehicle collision she sustained in 1996 when she was hit head on while driving. She underwent abdominal surgery for intestinal injuries. It seems as though she also lost some abdominal wall muscle on the right side from that event as well. She says at first it was repaired with goretex [sic] mesh and 70+ titanium staples. However, the hernia repair broke down. Dr. Selzer removed the old mesh and re-repaired the hernia. However, a seroma developed around the mesh, which she had aspirated. Her seroma recurred, and she has noted additional bulges around her umbilical region. Her hernias were painful and interfered with activities such as lifting. She is a type 2 diabetic on metformin. Physical examination: gastrointestinal: soft. Obese. There is a bilobed moderately large bulge in the umbilical region. The bulge appears to be herniated fat that is not acutely incarcerated, but cannot be reduced due to loss of domain. On the right lower lateral aspect of the abdomen, there is a firm-to-hard irregular mass corresponding to the area of mesh seen on the ct scan along with an abdominal herniation. Diagnosis: abdominal wall seroma. Class 2 obesity with bmi of 36. 0 to 36. 9. Retained foreign body of trunk. Umbilical hernia. Plan: i counseled (b)(6) regarding the nature of an abdominal wall reconstruction with bilateral component separations and implantation of mesh. Including its indications, alternatives, risks, and possible complications. She told me she wishes to proceed as soon as possible because of the continuous discomfort she is feeling. I explained that i think a lot of it is due to muscle spasms from abdominal wall muscle disease atrophy. I again explained that her hernias are problematic. I told her that both hernias could be repaired during the same operation. However, that would be difficult because: suspect that the flank hernia will need suture anchors drilled into the iliac crest to affix the muscle and/or mesh to the bone (which is difficult to do intraabdominally); given her obesity, it will be much more difficult to expose and work on the flank hernia from the anterior abdomen. In addition, i explained that, even if we went ahead and attempted to repair both hernias simultaneously or in sequence, there are major concerns: her obesity is a risk factor for infection and other complications and there is a good likelihood that she could develop a hernia at another abdominal wall weak area because she has more inside of her than she was built to hold¿i gave her my card and told her to return to clinic in one month for a weight check. ¿ explant preoperative complaints: on (b)(6) 2019: (b)(6). (b)(6), md. Clinic office records. Physical examination: ¿gastrointestinal: soft. Obese. There is diffuse tenderness to superficial palpation of her anterior abdominal wall muscles. There is a bilobed moderately large bulge in the umbilical region. The bulge appears to be herniated fat that is not acutely incarcerated, but cannot be reduced due to loss of domain. On the right lower lateral aspect of the abdomen, there is a firm-to-hard irregular mass corresponding to the area of mesh seen on the ct scan along with an abdominal herniation. When i have her strain her abdominal wall muscles by trying to sit up, i can feel excellent muscle contraction. Radiology results: computer tomography (i re-reviewed (b)(6) ct scan from (b)(6) 2018. It reveals two small umbilical defects with moderate-size fat herniations. On the right lateral abdominal wall in an irregular foreign body that is likely permanent mesh material with a contiguous seroma external to the mesh. A significant swath of the right rectus muscles and obliques is either severely attenuated or actually missing. There is clear detachment of the right obliques from the iliac crest. ) diagnosis: abdominal wall seroma. Class 2 obesity with bmi of 36. 0 to 36. 9. Retained foreign body of trunk. Umbilical hernia. Plan: i counseled (b)(6) regarding the nature of an abdominal wall reconstruction with bilateral component separations and implantation of mesh. Including its indications, alternatives, risks, and possible complications. She told me she wishes to proceed as soon as possible because of the continuous discomfort she is feeling. I explained that i think a lot of it is due to muscle spasms from abdominal wall muscle disease atrophy. I again explained that her hernias are problematic. I told her that both hernias could be repaired during the same operation. However, that would be difficult because: i suspect that the flank hernia will need suture anchors drilled into the iliac crest to affix the muscle and/or mesh to the bone (which is difficult to do intraabdominally); given her obesity, it will be much more difficult to expose and work on the flank hernia from the anterior abdomen. In addition, i explained that, even if we went ahead and attempted to repair both hernias simultaneously or in sequence, there are major concerns: her obesity is a risk factor for infection and other complications and there is a good likelihood that she could develop a hernia at another abdominal wall weak area because she has more inside of her than she was built to hold. She told me that she is now committed to continue to lose weight and avoid such a circumstance. I answered all of her questions to her satisfaction. We have scheduled her for repair for (b)(6). ¿ (b)(6) 2019: (b)(6). (b)(6) md. History and physical: subjective: ¿states she was injured by a drunk driver and she was injured in her abdomen and required partial colectomy and abdominal wall surgery with mesh/staples. States 2 years later the mesh was replaced due to pain. Following that surgery, she developed a seroma that required drainage. She continues to have pain secondary to the mesh/staples and has a persistent periumbilical hernia. Physical exam: gastrointestinal: + ventral hernia. Plan: abdominal wall hernia: surgical management per dr. (b)(6). ¿ on (b)(6) 2019: (b)(6). (b)(6), md. Preop diagnosis: ¿flank hernia, class 2 obesity with body mass index (bmi) of 36. 0 to 36. 9. Diastasis recti, flank hernia, retained foreign body of trunk. ¿ on (b)(6) 2019: (b)(6). (b)(6), md. Indications: ¿the patient is a (b)(6) female with a history of a traumatic hernia of her right flank in 1996. She underwent an initial repair, which later recurred. She then underwent a laparoscopic repair in 2006. Over the past few years, she has noted an increasing bulge and pain in the right flank region. Examination and imaging revealed a recurrent herniation in the area associated with a partially detached mesh with an adherent seroma. She underwent thorough preoperative evaluation and was scheduled at the current time for elective repair. ¿ explant procedure: repair recurrent right flank hernia. Excision of previous mesh with seroma from right flank. Sublay of 8cm x 16cm phasix st mesh for protection and reinforcement of right flank hernia repair. Repair initial ventral incisional hernias x3. Rectrorectus implantation of 25. 4cm x 30. Cm phasix mesh for reinforcement of midline component separation closure. [implants: phasix mesh x2] explant date: (b)(6) 2019 [hospitalization dates: (b)(6) 2019] on (b)(6) 2019: (b)(6). (b)(6), md. Operative records. Procedure: estimated blood loss: 300 ml. Iv fluids: 2500 ml. Specimens and cultures: mesh with seroma. Wound class: ¿clean. ¿ findings: ¿wide diastasis with multiple midline ventral hernias. Large chronic right posterolateral flank hernia with partially detached mesh containing seroma. Mesh and seroma excised. Flank hernia closed with continuous simple sutures of looped #1 pds. Sublay of phasix st applied over repair with continuous simple sutures of 2-0 pds. Modified rives-stoppa repair performed. Posterior sheaths approximated with continuous simple suture. ¿ procedure: ¿the patient was taken to the operating room. An epidural catheter was placed by the anesthesiologist for subsequent intraoperative and postoperative pain management in order to optimize pulmonary toilet and prevent postoperative pneumonia and/or respiratory insufficiency or failure. The patient was then placed under general endotracheal anesthesia. A time-out was performed, confirming the correct procedure, patient, and position. Preoperative antibiotics were administered intravenously by the anesthesiologist. A sterile prep and drape of the abdomen was performed. A midline incision was made through the skin, and the subcutaneous tissues were dissected laterally to identify the right rectus abdominis muscle. Similarly, the medial edge of the left rectus abdominis muscle was identified through blunt dissection in the subcutaneous tissues. The medial edges of the rectus sheaths were then opened sharply on both sides and incised from the rib cage to the pubis, thereby initiating the medial component separation. The medial component separation was then completed on both the right and left bipedicled myocutaneous advancement flaps by using careful blunt dissection to sweep the rectus muscles off the posterior sheaths all the way laterally to the lateral edges of the sheaths. Care was taken to avoid injury to the inferior and superior epigastric blood supply into the bipedicled muscle flaps in order to ensure flap viability. There was a wide diastasis noted between the posterior sheaths, with three moderate -sized incarcerated ventral hernias containing omental fat protruding through the attenuated fascia in the periumbilical region. The peritoneum was entered in order to incise the neck of each of the hernias to allow reduction of the incarcerated material. Dissection was then carried out in the preperitoneal space deep to the posterior sheath on the right to identify the right flank defect. The mesh and adherent seroma were identified and sharply dissected free. Multiple laparoscopic tacks were identified and removed, along with multiple polypropylene sutures in the abdominal wall. The mesh and seroma were excised in their entirety and sent for pathologic examination. The right flank defect was assessed. There was a transverse muscle edge superiorly corresponding the the [sic] patient¿s overlying right flank transverse scar. It was initially difficult to appreciate a muscle edge on the inferior aspect of the defect, making it appear that the muscle had avulsed off the iliac crest. Therefore, we employed initial efforts to place suture anchors into the iliac crest. However, it was difficult to adequately clear the bone from the surrounding extensive adipose tissues, and the angle for appropriate anchoring of the suture anchors was difficult to approach from our intraabdominal approach. With further dissection, however, we were able to identify and inferior muscle edge that corresponded to the superior edge already identifies [sic]. This muscle defect was closed with a continuous simple suture of looped #1 pds. A sublay of 8 cm x 16 cm phasix st mesh was soaked in antibiotic solution and then applied over the suture line and fixed muscle with continuous simple sutures of 2-0 pds. Following the medial component separation and after reduction and repair of the right flank hernia, medial traction on the posterior fascia as well as the anterior fascia and rectus muscles demonstrated that an adequate approximation could not be performed. The wound was irrigated thoroughly and hemostasis was achieved with electrocautery. The posterior sheaths were then approximated in the midline with continuous simple sutures of looped 0 pds, thereby initiating the midline approximation of the bilateral wall bipedicled medial advancement muscle flaps. A retrorectus underlay of 25. 4 cm x 30. 5 cm phasix mesh was soaked in antibiotics solution and then placed in the retrorectus space. Two 24 fr blake drains were placed in the retrorectus position and brought out through stab wounds in both lower quadrants. They were affixed to the skin with sutures of 2-0 nylon. The rectus muscle and anterior sheath were approximated then over the underlay with continuous simple sutures of looped #1 pds, thereby completing the midline approximation of the right and left bipedicled muscle flaps. The first sutures at the superior and inferior aspects of the incision were also placed through the mesh underlay to anchor the mesh in position. One 24-french blake drain was placed in the subcutaneous space and brought out through stab incisions; it was affixed to the skin with a suture of 2-0 nylon. As a result of the right and left bipedicled myocutaneous advancement flaps, the skin was able to be closed with skin staples. The wound was cleaned and dressed. The patient was extubated and taken to the recovery room in stable condition, having had an estimated blood loss of 300 ml and fluid replacement of 3,500 ml of crystalloid. I was physically present while performing the entire operation. ¿ (b)(6) 2019:(b)(6). (b)(6), md. Pathology report: operative procedure: abdominal wall repair. Specimen received: mesh plus seroma. Final pathologic diagnosis: ¿mesh, removal. Segment of fibrotic soft tissue with foreign body reaction and synthetic material. ¿ gross description: ¿received in formalin, labeled ¿(b)(6)¿ and ¿mesh plus seroma¿ is a 16. 5 x 7. 5 x 2. 0 cm tan, irregular, ragged synthetic material consistent with mesh. Multiple sutures/metallic coils are adherent to the specimen. There is a moderate amount of attached soft tissue. In the center aspect of the specimen is a 8. 0 x 5. 0 x 1. 5 cm smooth walled, uniloculated cystic area filled with a tan, viscid fluid. Representative sections of the soft tissue are submitted in two cassettes. ¿ on (b)(6) 2019: (b)(6). (b)(6), md. Discharge note: hospital course: ¿the patient was taken to the operating room on (b)(6) 2019 for excision of mesh and abdominal wall reconstruction with lumbar hernia repair period she tolerated the procedure well, however, did have hypo tension in pacu requiring admission to the icu. This resolved with appropriate fluid resuscitation. She also initially post operatively experienced acute kidney injury with creatinine peaking at 1. 75. This also resolved with adequate fluid resuscitation. Her diet was slowly advanced as tolerated. She was noted to have essential tachycardia not responsive to fluid boluses and was started on scheduled metoprolol by the icu team. This transition to oral 25 mg b. I. D. [two times per day]. She also experienced delirium while in the icu and seroquel was started. This was weaned and she will go home on a week and a half wean of her seroquel. At the time of discharge, she was tolerating a regular diet. Her pain was controlled with oral pain medications. All 3 of her operative drains remained in place and she received drain teaching. She will follow up with dr. (b)(6) on (b)(6) 2019 and she will follow up with her pcp tomorrow to discuss the changes in her medication. Disposition: home. ¿ ¿activity: no heavy lifting (10 pounds or more) or strenuous activity for 8 weeks after surgery. Follow up visit: (b)(6) 2019. ¿ relevant medical information: on (b)(6) 2019: (b)(6). (b)(6), md. Clinic office records: general surgery progress note. ¿subjective: patient has been having severe abdominal pain since her discharge. It is sharp in nature and bilateral, mid abdomen. Denies n/v [nausea/vomiting]. No fevers, chills. Physical examination: gi [gastrointestinal]: soft, tender to palpation, two anterior drains. One ruq [right upper quadrant] ir [placed by interventional radiology] drain, all ss [serosanguinous], staples along midline incision. Incision crusted. Impression and plan: patient is a (b)(6) female with recent abdominal wall reconstruction with dr. (b)(6) who then developed a seroma which was drained by ir. Following up for drain assessment and staple removal. Reiterated to the patient that her muscle pain is normal for this type of surgery and that will persist until the incision is healed. Patient has narcotic agreement on file. Staples removed, drains to remain in place due to borderline output. Drains re-anchored with sutures due to slight dehiscence. Patient to follow up at the two month mark. ¿ on (b)(6) 2019: (b)(6). (b)(6), md. Clinic office records: post operative visit: ¿chief complaint: drain check/staple removal. Interval history: she has been documenting her drainage appropriately, although she did require several educational sessions before she understood what she was supposed to do. Physical examination: gastrointestinal: soft. Healing surgical wound with staples in place. The drain stitches are nearly out. Diagnosis: postop check. Plan: we removed the staples and resecured the drains with sutures. I instructed her to return to the clinic at the 2 month point from the date of her operation. ¿ on (b)(6) 2019: (b)(6). (b)(6), md. Clinic office records: post operative visit: history of present illness: ¿on (b)(6) 2019, i performed repair of her right flank hernia via a midline approach with a sublay of phasix st mesh followed by a modified rives-stoppa midline repair with a phasix underlay. She was discharge on (b)(6). Physical examination: gastrointestinal: soft. Healing surgical wound with staples in place. The drain stitches are nearly out. Impression and plan: diagnosis: s/p [status post] abdominal surgery, follow-up exam. Plan: i instructed her to return to the clinic in 3 weeks. ¿ on (b)(6) 2019: (b)(6). (b)(6), md. Clinic office records: post operative visit: ¿interval history: all of her drains have been removed. She denies any fevers, chills, nausea, vomiting, diarrhea, or constipation. Physical examination: gastrointestinal: soft. Healing surgical wound with staples in place. The drain stitches are nearly out. Diagnosis: abdominal wall disease muscle atrophy, postop check. Plan: i instructed (b)(6) on the techniques and regimen for abdominal wall muscle strengthening exercises. I also instructed her to return to the clinic in 2 weeks. ¿ on (b)(6) 2019: (b)(6). (b)(6), md. Clinic office records: post operative visit: ¿interval history: at her last visit, i instructed her on the techniques and regiment for abdominal wall muscle strengthening exercises. She is up to 15 reptations of each exercise, bust she is only doing them once daily instead for the prescribed twice daily regimen. She denies any fevers, chills, nausea, vomiting, diarrhea, or constipation, although she does complain of abdominal pain, mostly in her right upper quadrant. Physical exam: gastrointestinal: soft. Healing surgical wound. Moderate tenderness of right rectus abdominus muscle with superficial palpation. No evidence of infection or hernia recurrence. She was also doing the exercises with her hands behind her head instead of on her muscles. Diagnosis: abdominal wall disease muscle atrophy. Plan: i re-instructed (b)(6) on the techniques and regimen for abdominal wall muscle strengthening exercises, telling her to do them twice daily. I instructed her to return at the 4-month point from the date of her operation. ¿.
 
Event Description
It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2006 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: adhesive disease, abdominal pain, dense adhesions, hernia recurrence, mesh contraction, and the need for additional surgical intervention. 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)
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 Key13181719
MDR Text Key287538865
Report Number2017233-2022-02657
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 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/10/2007
Device Model Number1DLMCP07
Device Catalogue Number1DLMCP07
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2005
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: 01/06/2022 Patient Sequence Number: 1
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