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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 1DLMCP08
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 03/05/2014
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)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence."  the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
 
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) 2014 and (b)(6) 2018, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: incision and drainage of abdominal wall abscess, explantation of infected mesh, and wound vac placement.Additional event specific information was not provided.
 
Manufacturer Narrative
B7: added medical history.H6: updated results code.Conclusion code remains unchanged h10/11: added medical record information.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) 2005: gens.[signature illegible].Office notes.Infected abdominal wall hernia mesh.The patient has undergone open gastric bypass surgery on (b)(6) 2003 with subsequent repair of her ventral hernia at that time.The patient reports a long complicated extended history of recurrent surgeries for this hernia with repeated mesh infections.The patient states she had a recent abdominoplasty in (b)(6) 2005 with also repair of her hernia.Reports large abscess following surgery and with subsequent removal of the mesh and wound vac care following this procedure.Currently, she reports a draining abscess at her umbilicus.Reports no fevers, but has intermittent chills.Tolerating post gastric bypass diet and does not state any nausea or vomiting.Surgical history of ventral wall hernia repair x3.Weight 231.6 pounds.Exam: abdominal exam reveals midline incision as well as abdominoplasty incision.The patient also has palpable midline ventral hernia at upper portion of her midline incision extending all the way down to her abdominoplasty scar.Also has approximately a 2 x 3-cm draining ulcer at the inferior portion of the midline incision.There is no evidence of erythema or fluctuance at this time.Impression: recurrent ventral hernia with likely contamination of her ventral hernia mesh.I discussed the risks and benefits of repairing her ventral hernia.We discussed the possibility of removing the mesh followed by laparoscopic ventral hernia repair with replacement of mesh following healing of her wound.The patient was in agreement with this and surgical date was set for (b)(6) 2005 for removal of her infected mesh.¿ (b)(6) 2005: (b)(6) center.[signature illegible].History and physical.History of ventral hernia repair now with infected mesh.Patient status post open gastric bypass 2003 with ventral hernia repair at that time.Patient with recent abdominoplasty 3/05 with repeat ventral hernia repair.Since then, patient has had chronic wound with exposed mesh; no fevers, +chills.History of hypertension, gastroesophageal reflux disease.Surgical history of roux en y gastric bypass, 9/03; ventral hernia repair x3; cholecystectomy 1987; cesarean section 1989.Exam: abdomen soft nondistended, tender to palpation [illegible] ~3 cm x 2 cm, minimal erythema.Impression: infected hernia mesh.Mesh removal.¿ (b)(6) 2005: (b)(6) medical center.[signature illegible].Anesthesia record.Physical status: 3.¿ (b)(6) 2005: (b)(6) medical center hospital.(b)(6), md.Operative report.Assistant: (b)(6), md; (b)(6), md.Preoperative diagnosis: infected ventral hernia mesh.Postoperative diagnosis: infected ventral hernia mesh.Procedure: removal of infected ventral hernia mesh.Anesthesia: general anesthesia.Lv fluids given during the procedure: 1500 cc of lr.Estimated blood loss for the procedure: 50 cc.Condition of patient after surgery: stable and extubated to the pacu.Hpi: ¿the patient is a 47-year-old female electively admitted for removal ventral hernia mesh.The patient had previous open roux-en-y gastric bypass surgery with subsequent ventral hernia repair and abdominoplasty.The patient presented to the clinic two weeks ago with an approximately 2 by 2 cm area at her old umbilical site with exposed mesh.There was currently no evidence of cellulitis or purulence of induration at that site.¿ description of procedure: ¿the patient was wheeled into the room and placed in a supine position.After induction of general anesthesia, the abdomen was prepped and draped in a sterile fashion with betadine.A foley catheter was inserted in the usual typical fashion.Following this a vertical incision was made through the old midline incision with a #10 blade down to the exposed mesh area.The incision was then carried around this area and down inferior to it.The subcutaneous tissue was carefully opened with bovie electrocautery.Once this was achieved, an area of mesh was divided at the midline.Next the mesh was able to be grasped with kocher clamps on each side and retracted upward.Underlying attachments were carefully removed with sharp dissection using metzenbaum scissors.The mesh appeared to be a marlex type, it was ingrown into the overlying fascia.Once the underlying attachments were removed with metzenbaum scissors on the left side, a similar procedure was done on the right side.Once this was achieved, flaps from the mesh were created as the skin was retracted laterally.This was done on each size to fully expose the mesh laterally and inferiorly.Once this was done the mesh edges were removed using the bovie electrocautery.Around the 2 cm ulcerated site an area of skin was also excised with a #10 blade.The mesh from this area was completely removed on its inferior aspect.Using careful sharp dissection, the edges of the mesh were dissected freely on both sides.Once this was done the wound was irrigated and dried.The mesh was sent off the table for culture.Next, the remaining fascial edges were approximated with running #1 pds suture.Following this, the subcutaneous tissue was approximated with interrupted 2-0 vicryl sutures.The skin was then closed with a running 3-0 monocryl subcuticular stitch.The wound was cleaned and dried.Mastisol and steri-strips were applied.The patient tolerated the procedure well.The patient tolerated the procedure well.All counts were correct.Dr.(b)(6) was present for the entirety of the case.¿ ¿ (b)(6) 2005: (b)(6) hospital.(b)(6), md.Surgical pathology report.Case #: (b)(4).Final diagnosis: soft tissue and mesh, ventral hernia repair site, removal: synthetic mesh (gross diagnosis).Fibroadipose tissue with chronic inflammation and foreign body giant cell reaction.Specimen: a) soft tissue infected graft.# of blocks: 1.Clinical history: unspecified.Pre-op diagnosis: infected graft.Surgical procedure: exp lap.Gross description: the specimen is labeled ventral hernia mesh.Received in formalin are four fragments of yellow/tan fibrofatty soft tissue attached to a white synthetic mesh.The soft tissue and mesh measure 11 x 7 x 2.5 cm in aggregate.Serial dissected away from the mesh and submitted for histologic diagnosis is one cassette.¿ (b)(6) 2005: (b)(6) medical center.Lab-anaerobic cultures.Source: ventral hernia mesh.No anerobic growth after 5 days.¿ (b)(6) 2005: (b)(6) medical center.Lab-bacterial cultures.Source: ventral hernia mesh.Gram stain: few wbc¿s seen.No organisms seen.Coryneform bacilli was isolated.¿ (b)(6) 2005: (b)(6) medical center.(b)(6), md.Discharge summary.Admission date: 9/29/05.Discharge diagnosis: infected ventral hernia mesh, status post removal of infected mesh.Had previously undergone open gastric bypass surgery at an outside hospital on (b)(6) 2003 with subsequent repair of the ventral hernia at that time.Has had multiple repeat surgeries for this ventral hernia.In (b)(6) 2005, had abdominoplasty with a concomitant repair.Following this surgery, developed a wound at her umbilicus with exposed mesh.Hospital course: was admitted with complaints of increased abdominal pain.Was seen in the emergency room and admitted.Was preop¿d for surgery the following day.Was afebrile and was tolerating a regular diet.Reported increased abdominal pain in her mesh site.During surgery, had removal of the infected mesh.Had approximately 50 cc of blood loss and 1500 cc of crystalloid.Was subsequently extubated and stabilized in the post anesthesia care unit and sent to the general surgical postoperatively.On postoperative day #1, controlled anesthesia pump was discontinued.Was continued on percocet as needed.Was able to tolerate clears and ambulated well.Foley catheter was discontinued.Continued to do well.Blood pressure improved with discontinuation of morphine.On postoperative day #2, was advanced to a regular diet, which she tolerated well.On postoperative day #3, had passage of flatus.Was tolerating a regular diet.Pain was controlled with percocet.Was subsequently discharged home on (b)(6) 2005.Was instructed to avoid heavy lifting greater than 20 pounds for the next 2 weeks until being seen in the clinic.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Procedure report.Preoperative diagnosis: family history of colon cancer.Postoperative diagnosis: mild left-sided diverticular disease.Internal hemorrhoids.Procedure: colonoscopy.Impression: mild left-sided diverticular disease.Internal hemorrhoids.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Procedure report.Preoperative diagnosis: increasing reflux symptoms.Postoperative diagnosis: small to medium sized hiatal hernia, status post biopsy to rule out short segment barrett¿s esophagus.Procedure: upper endoscopy.Findings: there was a small hiatal hernia noted.Impression: hiatal hernia.Rule out short segment barrett¿s esophagus.¿ (b)(6) 2006: [facility ni].(b)(6), md.Office notes.Follow up.Has a residual ventral hernia below the umbilicus that is going to require repair later this summer.Exam: abdomen: there is very distinct and reproducible tenderness just below the xiphoid process at the upper edge of her previous surgical midline vertical incision.There is extensive scar tissue and healing of the lower aspect of the same incision just a suprapubic and below the umbilicus.She is tender just below the umbilicus where she is noted to have a hernia.Impression/plan: gastroesophageal reflux disease, barrett¿s esophagus, diabetes mellitus type ii, asthma.Epigastric discomfort.I cannot palpate a large hernia, however upon reviewing her previous ct scans there is a report from (b)(6) 2005 suggesting a small hernia.[missing pages].¿ (b)(6) 2006: (b)(6) medical center.(b)(6), md.Office notes ¿ letter to dr.(b)(6).Underwent a gastric bypass in 2002, postoperatively she developed an incisional hernia and has undergone 2 incisional hernia repairs with mesh, both of them subsequently becoming infected.On (b)(6) 2005 i removed the infected mesh.Recently underwent a transvaginal hysterectomy and bladder suspension at an outside hospital.She states that after that surgery her remaining ventral hernia has gotten much worse, she states the pain is increasing.By examination, she does not have any evidence of incarceration.We had discussed with her the need to allow the infection subside over the course of months, and then subsequently plan on a repair, reimplanting an additional piece of mesh.Surgical history: incisional hernia repair x2.Medications: aspirin.Weight 270 lbs.Exam: abdomen: soft, with evidence of an obvious incisional hernia.It is easily reducible, no evidence of incarceration.Impression/plan: recurrent ventral hernia repair, history of mesh infection, mesh has been removed.Will plan on repairing patient¿s incisional ventral hernia in the next few weeks, by laparoscopic technique.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Procedure report.Preoperative diagnosis: carrett¿s esophagus with low grade dysplasia.Postoperative diagnosis: barrett¿s esophagus with low grade dysplasia status post biopsy.Procedure: upper endoscopy.Impression: barrett¿s esophagus status post biopsy.Small hiatal hernia.¿ (b)(6) 2006: (b)(6) medical center.[signature illegible].Pre-operative history and physical.Weight 264 lbs.Problem list: ventral hernia; bmi >35.Asa iii.Implant procedure: laparoscopic ventral hernia repair with 34 cm by 28 cm gore dual mesh.Extensive lysis of adhesions consuming 70 minutes of operative time.Implant: gore® dualmesh® plus biomaterial [1dlmcp08/03885654, 34 cm x 28 cm] implant date: (b)(6) 2006 (hospitalization august (b)(6) 2006).¿ (b)(6) 2006: (b)(6) medical center hospital.(b)(6), md.Operative report.Assistant: (b)(6), md.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: ventral hernia.Anesthesia: endotracheal, general.Estimated blood loss: 50 cc.Iv fluids given: 1 liters of crystalloid.Complications: none.Specimen: none.Intraoperative findings: included the following: 1) large ventral hernia repair, through prior incision.2) included within the hernia sac were both small bowel and large bowel, small component of stomach.3) there was approximately 70 minutes of operative time required to completely lyse adhesions.Brief history: ¿this patient is a 48-year-old female with a past medical history significant for morbid obesity.She underwent an open gastric bypass at a separate institution.From the gastric bypass she did develop a midline hernia.She had multiple attempts at repair.Both procedures did result in an infected mesh.The mesh had to be removed.She has since been having complaints of abdominal pain and obvious recurrence of her ventral hernia.She was evaluated in the surgical clinic for repair.She was apprised of the risks and benefits to proceed ahead and she agreed to proceed.¿ description of procedure: ¿the patient was brought into the operating room and placed supine on the or table.Now an or time-out took place confirming the patient identification as well as the procedure.Adequate endotracheal anesthesia was then administered.A foley catheter was placed under sterile technique by the surgical team.The patient¿s abdomen was then prepped and draped in normal sterile fashion, including ioban dressing.First a 1 cm incision was made in the right upper quadrant.Using blunt dissection the external oblique was exposed.This was incised sharply and blunt dissection was used to enter the abdominal cavity.A 10 mm balloon trocar was then placed.Pneumoperitoneum was achieved and set at 15 mmhg.Next additional working ports were sequentially placed.The first was a right lower quadrant port.Next a left lower quadrant port was placed and finally a left upper quadrant port.All additional ports were placed under direct visualization with the use of local anesthetic.In order to facilitate the placement of all the ports, extensive lysis of adhesions was required.Lysis of adhesions was done with mostly sharp dissection.Bleeding was controlled using endoloops as well as clips.After all of the adhesions had been lysed, the fascial defect was delineated on the anterior abdominal wall.The dimensions of the defect were measured and an appropriately sized mesh (34 cm by 28 cm) gore dual mesh was passed onto the field.0-gore sutures were preplaced into each of the sides of the mesh.The mesh was rolled and placed into the abdominal cavity through the balloon port site.Within the abdominal cavity, the mesh was unrolled, insuring that the smooth portion was facing the intestines and the rough side was facing the fascial wall.Using a carter-thompson device, the preplaced suture was grasped and affixed to the anterior abdominal wall.Next an endotak device was then used to peripherally reinforce the edges of the mesh to the anterior abdominal wall.Additional reinforcing sutures of 0-gore were used to reinforce the mesh of the anterior abdominal wall insuring that no suture was spaced more than 6 cm apart from the nearest one, along the perimeter.Next the abdomen was again inspected for hemostasis and hemostasis was noted.Next the right upper quadrant port site was closed using 0-vicryl in a figure-of-eight fashion.All skin incisions were closed using 4-0 monocryl in a subcuticular fashion.All skin incisions and nicks for the carter-thompson device were sealed using dermabond skin adhesive.All instrument, sponge and needle counts were reported correct by the or staff.Patient tolerated procedure well, was extubated and transferred stable to the post-anesthesia care unit for continued observation on the floor.Dr.(b)(6) was scrubbed and present throughout the entire procedure.¿ ¿ (b)(6) 2006: (b)(6) medical center hospital.(b)(6), md.Operative report.Assistant: (b)(6) ,md.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: multiple recurrent ventral hernias.Procedure: laparoscopic ventral hernia repair with mesh 26 cm x 34 cm dual mesh.Lysis of adhesion, 70 minutes.Anesthesia: general endotracheal anesthesia.Estimated blood loss: 50 ml.Lv fluids: 2 liters crystalloid.Drains: none.Specimens: none.Findings: 1) multiple ventral hernias from previous midline surgeries.2) numerous adhesions of omentum to small bowel and colon hernias.3) status post gastric bypass.4) no evidence of other gross abdominal findings noted.Indications: ¿the patient is a woman with a previous gastric bypass and multiple ventral hernias with an attempt at repair that had been unsuccessful.She has had ongoing pain, difficulties and problems related to her hernias.She is now interested in laparoscopic approach for repair of her hernia.After all the risks, benefits, and outcomes were discussed with the patient, informed consent was obtained.¿ description of procedure: ¿the patient was placed on the operating room table in standard supine manner.General endotracheal anesthesia was administered.Chloroprep of the abdomen was done.Foley catheter was inserted in sterile fashion and sequential compression devices were placed on the legs.At this point, using an open cut down technique, the skin was opened sharply using blunt dissection in the posterior sheath.Entry was made into the peritoneum.Balloon tip trocar was introduced and the distal portion placed in subsequent all four quadrants of the abdomen and lysis of adhesions was begun.Lysis of adhesions, 70 minutes, was then done of omentum, small bowel and colon that were attached to multiple hernias from previous midline.These were taken down sharply and without problems.Final examination of the bowel showed no injury or problems.There was no bleeding noted.All areas of abdominal wall were noted to be within the field that would be covered by 26 cm x 34 cm piece of mesh.This 26 cm mesh was then fixed outside the patient in four quadrants and then rolled and brought in though one of the trocar sites.It was then attached to the abdominal wall using the carter-thompson to fixate this mesh in four quadrants against the abdominal wall.Using a protack device and sequential tacking of the hernia was done in a circumferential fashion to adhere the mesh to the abdominal wall.Additional sutures were then placed in a 6 cm circumference around the entire mesh after skin incisions were made at the site using a carter-thompson.The mesh was then fixated at 6 cm intervals around the entire abdominal wall without problems.Final examination throughout again showed good hemostasis.No evidence of any bowel injury.No evidence of any organ injury and no evidence of intestinal problems.The trocar sites greater than 10 mm were closed using interrupted gore-tex suture in a figure-of-eight fashion.All trocars and instrumentation were then removed again after examination was done throughout the abdomen to ascertain that there was no evidence of any complication from the operation.This was assured, the trocars were removed and skin was brought into reapproximation using 4-0 monocryl and dermabond skin adhesive.The patient was then awakened, extubated and taken to the pacu in good condition after all sponge, needle, and instrument counts were noted to be correct.¿ ¿ (b)(6) 2006: (b)(6) medical center.Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp08.Lot batch code: 03885654.W.L.Gore & associates.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp08/03885654) was implanted during the procedure.Relevant medical information: ¿ (b)(6) 2006: (b)(6) medical center hospital.(b)(6), md.Discharge summary.Discharge diagnosis: ventral hernia.Status post laparoscopic ventral hernia repair with mesh.She had undergone gastric bypass in 2002 and postoperatively she developed an incisional hernia and has undergone two incisional hernia repairs with mesh.On 9/30/05, the infected mesh was removed.States after that surgery her remaining ventral hernia has gotten much worse.Surgical history: incisional hernia repair x2.Medications: aspirin.Hospital course: patient had no intraoperative complications, no leaks.Patient had a postoperative ileus.Stated on clear liquid diet postop day 3.Tolerated that well and had positive flatus.Therefore, was advanced on her diet.Pain management controlled.Patient controlled analgesic stopped on postop day 1.Continued on morphine iv, which was stopped postop day 4.Patient doing well and tolerating pain with p.O.Percocet pain medications.Discharge instructions: follow up with dr.(b)(6) in 2 weeks.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.History and physical.Underwent laparoscopic hernia repair of open ¿greater than 15¿ abdominal wall hernias seven days ago.Was discharge yesterday but feeling she could not tolerate p.O.Not able to eat or drink.Developed nausea.Meds: aspirin.Medical/surgical history: status post gastric bypass surgery for morbid obesity, weight reduction.Postoperative course complicated by an infection, recurrent wound infection requiring multiple debridement procedures.She then experienced multiple recurrent abdominal wall hernias with repeated attempts at repair and subsequent postoperative infection.Recent hysterectomy in june with bladder surgery.Cesarean section.Chronic morbid obesity.Non-insulin dependent diabetes, insulin requiring, currently controlled by diet.Gastroesophageal reflux disease.Hiatus hernia.History of chronic anemia.Asthma.Social history: does not smoke or drink.Exam: abdomen: small incisional scars scattered across the abdomen with at least six scars on each side of abdomen, upper and lower.Tenderness, no fluid collection, discharge, erythema.Impression/plan: postoperative, nausea, poor p.O.Tolerance with subsequent dehydration, status post parenteral therapy in the emergency department, but still poorly tolerant.Admit overnight for additional hydration, antiemetic therapy and analgesic management.The patient does not show signs consistent with an obstruction or an infectious process presently.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Radiology ¿ ct pelvis.Indication: abdominal pain.Findings: postoperative edema present in anterior abdominal wall status post hernia repair.No obstruction.There is no evidence of free fluid in the pelvis.Impression: status post hysterectomy.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Radiology ¿ ct abdomen.Indication: abdominal pain.Findings: status post abdominal wall hernia repair.Significant and heterogenous thickening is present in the subcutaneous soft tissues.No recurrent herniation of bowel.No evidence of bowel obstruction.There appears to be some fluid within the anterior abdominal wall.Impression: small right pleural effusion.Abdominal wall hernia repair with postoperative soft tissue swelling, edema, and fluid.No recurrent herniation of bowel or obstruction.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Discharge summary.Admit date: (b)(6) 2006.Diagnosis: abdominal pain, status post laparoscopic mesh hernia repair abdominal wall.Dehydration.Chronic morbid obesity.Hospital course: noted for a finding anemia.Abdominal pain, gradually improve with rest and hydration.Ct abdomen showed abdominal wall hernia with postoperative soft tissue swelling, edema, and fluid, but no recurrent herniation or obvious bleeding.No bowel obstruction noted.Ct status post hysterectomy without other acute findings.Consulted by dr.Scheel, surgical consultant, felt patient had benign abdominal exam postoperative, and agreed with discharge on (b)(6) 2006.Noted to have substantial anemia, given packed red blood cell transfusion.Follow up with hematology outpatient regarding intravenous iron infusions and procrit therapy.Activity restricted until cleared by primary surgeon.Meds: aspirin.Disposition: improved.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Radiology ¿ abdomen (flat & upright).Indication: abdominal pain.Findings: evidence of mesh repair of ventral hernia.There is no apparent intraperitoneal free air.There are few air fluid levels seen in the small bowel, but there is no apparent bowel dilation.Impression: status post mesh repair of ventral hernia.A few no-specific air fluid levels are noted in the small bowel with no evidence of obstruction.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Radiology ¿ ct pelvis.Indication: right lower quadrant.Impression: no apparent acute intrapelvic findings.See report from the ct abdomen regarding abnormality in the abdominal wall related to ventral hernia repair.¿ (b)(6) 06: (b)(6) hospital medical center.(b)(6), md.Radiology ¿ ct abdomen.Indication: right lower quadrant pain.Findings: prior cholecystectomy.Patient is status post mesh repair of a midline ventral hernia, with the mesh extending from fairly high in the epigastrium downward to the umbilicus.There is a huge fluid collection present in the abdominal wall, both anterior and posterior to the mesh, with dimensions 21 cm transverse x 13 cm anteroposterior x 20 cm cephalocaudal.The bulges posteriorly against the peritoneal cavity with associated posterior displacement of small bowel loops, the transverse colon, and to a minimal degree the stomach.However, the collection does appear to be extraperitoneal in location in its entirety.It appears to have a thin soft tissue rim.There is only trace associated stranding in the abdominal wall, which may simply be the baseline appearance of the abdominal wall fat.Aside from the high-density mesh running though this collection, there are no other high-density components.The collection has an attenuation estimated at 14 hounsfield units.The largest part of this collection is posterior to the mesh, with less fluid present anterior to the mesh.On prior study (b)(6) 2006, there was not any discrete fluid seen, but along the anterior margin of the mesh there some lobular heterogenous density with substantial high-density components, consistent with some hematoma.There is no apparent intrabdominal fluid collection, an inflammatory process, or free air.Impression: there is a huge fluid collection surrounding the mesh at the site of ventral hernia repair, measuring as large as 21 cm.The largest part of this is posterior to the mesh, but there is significant component present anteriorly as well.There was some hematoma, relatively mild, along the anterior margin of the mesh on exam 8/02/06, and it is possible that there was subsequently quite a bit more hematoma that developed and that has now liquified.Differential diagnosis would also include an abscess (although there is not clearly significant inflammatory changes surrounding the collection), or seroma.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.History and physical.Acute right lower quadrant abdominal pain.Seen in my office and transferred to the emergency room for acute abdominal pain.Diagnostic study revealed a normal cbc, but the presence of a very large seroma surrounding the abdominal wall mesh material.Discharge home on pain medications.Experience worse pain of her life.Episodes of vomiting.Anorexia since then.Been taking narcotic analgesics for attempted relief of pain.Has not had fever or chills.Surgical history: gastric bypass 2003, cesarean section x2.Impression/plan: persistent transiently worsening abdominal pain with history of complexed abdominal wall surgery, large seroma or hematoma.Patient appears pale, needs stat cbc.Repeat ct to determine progression of previous hematoma/seroma or evidence of other process including abscess.Surgical consultation.¿ (b)(6) 2006: (b)(6) hospital medical center.(b)(6), md.Consultation.Complaining of persistent pain and pressure in recent weeks.Exam: abdomen: long midline scar which is not recent.There are also more recent, well healed laparoscopy scars laterally.In the central abdomen, there is diffuse fullness from the umbilicus to the xiphoid.It is symmetrical, quite large, mildly tender, with no inflammation.Impression: likely has a large seroma which appears to be producing enough pressure to be quite symptomatic.Ct scan shortly.I assume the findings will be comparable to last week.If so, aspiration of this fluid may be warranted to give at least temporary symptomatic relief.This is causing enough pressure to demand a different approach.10/16/06: champlain valley physicians hospital medical center.John mcauliffe, md.Operative report.Preoperative diagnosis: abdominal wall seroma.Postoperative diagnosis: abdominal wall seroma.Procedure: aspiration of abdominal wall seroma.Indications: ¿this 48-year-old woman had a massive abdominal wall hernia repaired by laparoscopic implantation of a large sheet of prosthetic material 2 months ago in albany.In recent weeks, she had increasing abdominal pain and distention.Ct scan showed quite a massive fluid collection both anterior and posterior to the prosthesis.Although the seroma was not unexpected, her symptoms were such that she was hospitalized earlier today.The size of the collection and her symptoms seemed to warrant at least some attempt to decompress the fluid collection.¿ description of procedure: ¿at the patient¿s bedside, the abdominal wall was prepped with betadine and draped.Xylocaine 1% was injected locally near the midline over the center of the palpable mass.An 18-gauge 2-inch intravenous catheter was driven into the abdominal wall until there was free flow of a dark bloody odorless fluid.The needle was withdrawn and the plastic catheter held in place.A 60-cc syringe was used to aspirate as much fluid as possible through this cannula repeatedly.The cannula was repositioned a couple of times at the same site, and there was gentle pressure applied elsewhere in the abdomen to coax as much fluid as possible through the cannula.Finally, approximately 750 ml of this fluid was evacuated.The patient was very significantly relieved of her pain.A small amount of the fluid was sent for culture, although there was no indication it was infected.The catheter was withdrawn, and a dressing was applied.The patient tolerated the brief procedure well.¿ see attachment for h10/11 continuation.
 
Manufacturer Narrative
H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Manufacturer Narrative
Retracting all medwatches associated with this report number as this was found to be a duplicate event.This event was captured previously under medwatch 2017233-2020-01356.
 
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Brand Name
GORE® DUALMESH® PLUS BIOMATERIAL
Type of Device
MESH, 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
heidi womble
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11749343
MDR Text Key248413226
Report Number2017233-2021-01923
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132601158
UDI-Public00733132601158
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,Followup,Followup
Report Date 05/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/27/2007
Device Model Number1DLMCP08
Device Catalogue Number1DLMCP08
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/22/2021
Initial Date FDA Received04/29/2021
Supplement Dates Manufacturer Received05/14/2021
05/14/2021
05/14/2021
Supplement Dates FDA Received05/28/2021
11/01/2021
05/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
Patient SexFemale
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