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

W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Catalog Number 1DLMCP03

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2017

Event Type Injury

Manufacturer Narrative

Added medical history.(b)(4).(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and 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 open ventral and incisional hernia repair on (b)(6) 2016 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, mesh removal, infection, and mesh failure.Additional event specific information was not provided.

Manufacturer Narrative

B7: added patient medical history d4: added lot number, expiration date, di # h4: added device manufacture date h6: updated method code for manufacturing and sterilization evaluations h6: updated results code h6: 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: a culture report dated (b)(6) 2015 of a ¿breast¿ specimen collected (b)(6) 2015 states: ¿organism 1: staphylococcus aureus.¿ records dated (b)(6) 2016 indicate the patient was seen for ¿black stool for 4 days, [abdominal] pain, nausea, light [headache].¿ ct scan results state: ¿1.Midline ventral hernia containing non-obstructed transverse colon.There is no evidence of vascular impairment to the bowel entering this hernia on today¿s exam.2.Remote cholecystectomy and hysterectomy.3.Remote aortic stenting without evidence of aneurysm or leak.¿ operative records dated (b)(6) 2016 indicate the patient underwent ¿repair of ventral incarcerated incisional hernia with mesh.¿ preoperative diagnosis states: ¿1.Large ventral incarcerated incisional hernia.2.Supraumbilical pain.¿ indications state: ¿48 year old white female who i have evaluated in the office for supraumbilical abdominal pain.She has had previous abdominal surgery and has been noted to have an incarcerated supraumbilical hernia with omentum within it.¿ ¿she has had some nonreducible transverse colon within this and they agreed to the hernia repair.¿ the (b)(6) 2016 operative report states: ¿i added 500 of vancomycin due to the fact that the patient has had a previous history of mrsa infections.No active infections at this point or in the last couple of months.Her upper midline incision was opened from below the xiphoid process down to the and just below the umbilicus.I opened the skin and subcutaneous tissue.There was a large supraumbilical hernia sac.There were two more ventral hernias, nonincarcerated, below this and then there was a small umbilical hernia.I separated the umbilicus from the fascia.I had healthy infraumbilical fascia with no further herniations identified.I opened up the hernia sac and reduced the colon back into the abdominal cavity.I connected the three ventral hernias and the umbilical hernia creating one hernia defect.I excised some of the denuded tissue of the hernia sac.I cleaned back to healthy fascia.I removed the skin from healthy fascia.¿ the (b)(6) 2016 operative report continues: ¿there was approximately 5 cm circumferential around the hernia defect.Once i entered the abdominal cavity, i took down adhesions of omentum mainly, a little bit of some small intestine from the anterior abdominal wall.I then chose gore dual mesh and i sutured it circumferentially in the abdominal cavity as a sublay with interrupted u-shaped 0 prolene sutures, completely suturing it circumferentially and closing the defect under direct vision to make sure that there was no intestine or omentum coming through the mesh.I then irrigated extensively with saline.I closed fascia back to the midline, closing tissue over the mesh.I placed a jp drain.I reconnected the umbilicus to the fascia with a 2-0 vicryl suture, closed the subcu, closing the dead space with 2-0 vicryl sutures and closed the skin with staples.¿ the (b)(6) 2016 records confirm a gore dualmesh® plus (1dlmcp03/15269226) was implanted during the procedure.Records dated (b)(6) 2017 indicate the patient was seen for ¿right lower quadrant pain that started this morning.Pain is sharp and constant she also has nausea but no vomiting no fever pain does not transit anywhere else.The patient had hernia repair done 3 weeks ago of the abdominal wall has a history of hysterectomy.¿ abdominal exam notes state: ¿normal inspection, patient has right lower quadrant tenderness no guarding or rebound.She also has a scar below the umbilical area from recent hernia repair has no cva tenderness.¿ ct scan results dated (b)(6) 2017 state: ¿there is interval anterior abdominal hernia repair with mesh placement.There are soft tissue densities in the anterior abdominal wall related to the recent surgery.Deep to the mesh, there is a thin layer of low density of about 8 mm maximum thickness and most likely to be a small seroma.¿ ¿impression: 1.Normal appendix.2.Interval anterior abdominal wall hernia with mesh placement and postsurgical change.There is a postsurgical seroma abutting the mesh deep to the mesh of about 8 mm thickness.3.Oblong cystic lesion in the central pelvis, most likely to be a physiologic cyst of the left ovary.It measures about 1.4 x 2.4 cm.¿ records dated (b)(6) 2017 indicate an abdominal ultrasound was performed to ¿evaluate for the abdominal wall seroma¿.Impression from the ultrasound states: ¿fluid collection in the deep mid abdominal wall measuring at least 4.6 x 1.5 cm in diameter and 9 mm in thickness.The peripheral margin of the fluid collection is difficult to evaluate due to the shadowing.¿ records dated (b)(6) 2017 state: ¿the patient is a 49 year old white female who back on (b)(6) i did a ventral incarcerated hernia repair with mesh.The patient was having generalized abdominal pain and at that time one of the etiologies was felt to be a hernia that had colon within the abdominal wall hernia and we recommended repair of this.Since that time she has been having bouts of intermittent abdominal pain.She was seen in the emergency room on or around (b)(6) 2017 and a repeat ct scan was performed that showed a small seroma but no other etiology for her pain.I recently started seeing her in the office for generalized abdominal pain.She canceled a colonoscopy that i set up for her and saw a gi team who did an egd and colonoscopy that showed no etiology or obvious source of her pain and they told her it was irritable bowel and recommended treatment for irritable bowel.¿ the (b)(6) 2017 records continue: ¿she returned back to see me recently.I did an abdominal ultrasound that showed a small seroma several weeks ago.Last week i offered her admission as she stated her pain was a 9/10 but she declined in order to attend post easter family festivities.Today we received a call that she was complaining of 8 out of 10 pain and this time she agreed to letting me admit her.She denies nausea or vomiting.No diarrhea, no rectal bleeding.No weight loss.I am not sure if i definitely improved her pain by repairing her hernia.On admission today, the patient has had a cbc, chem profile with lipase and they were all normal.No evidence of any pancreatitis.¿ the (b)(6) 2017 records state: ¿abdomen: well healed abdominal incision.Soft, non-distended.There is no rebound, guarding or peritonitis.When i push diffusely she does complain of tenderness but it is not a consistent exam.Sometimes she is tender in the right mid quadrant, sometimes the left mid quadrant especially with distraction.When you are talking with her there is not a consistent abdominal exam.¿ ¿assessment: 1.Generalized abdominal pain that the patient rates an 8 out of 10 of unclear etiology.2.Coronary artery disease.¿ ¿plan: 1.I am going to get a ct scan of the abdomen and pelvis and compare it to previous ct scans.2.If there is still a seroma i may ask them to drain this and i have discussed this with the patient and she agrees to this.I am not sure what the etiology of her abdominal pain is.She has had a lot of imaging post-procedural being performed and obviously she had a lot of abdominal pain prior to the procedure.I thought i would make it better by repairing her hernia but obviously she is still having diffuse abdominal pain of unclear etiology.I will make further recommendations after her ct scan.¿ ct scan results dated (b)(6) 2017 state: ¿evidence of anterior abdominal wall hernia repair with mesh placement.Previously demonstrated small seroma has resolved.¿ ¿impression: 1.Cystic lesion in the left ovary probably representing physiologic cyst.However, it could be correlated with a pelvic ultrasound.This may represent the same lesion as the cystic lesion demonstrated on the previous study.2.Anterior abdominal wall hernia repair with mesh placement.Resolution of the small seroma demonstrated on the previous study.¿ discharge summary records dated (b)(6) 2017 state: ¿patient is a [49] year old white female who i saw a week previously in the office for continued generalized abdominal pain.She just points from her flanks all the way across the abdomen.When i saw her in the office at that time she said her pain was a 10/10 and i recommended admission to the hospital but she declined admission as she had some post-easter family functions that she wanted to go to.I put her on motrin 800 mg.Tid and she went several days and called the office on the day of admission that she is still having the abdominal pain and would like to be admitted.The patient's history is that i saw her back in november and (b)(6) 2015.She was having generalized abdominal pain at that time.We started a workup on her including ct scans and what we did identify is that she had a ventral incisional hernia with a piece of colon trapped within it and i recommended repair of this but her pain at that time was also from her flank to her flank.¿ the (b)(6) 2017 discharge summary continues: ¿i repaired the hernia with mesh and she had on and off pain issues afterwards and then we never got her pain free despite repairing her hernia.The colon was placed back and the incarcerated colon was placed back in the abdominal cavity.She went to the emergency room in january for a workup that all of her laboratory values were normal.Her ct scan showed a tiny seroma.I then saw her in the office.I recommended a colonoscopy as she was also having some diarrhea.She cancelled my colonoscopy and saw a gi group at st.E's and had an egd and a colonoscopy that no significant findings were found and they recommended treating her with bentyl for irritable bowel.She came back to my office for this visit and that is when i recommended admission as i could not find an obvious etiology for her symptoms.¿ the (b)(6) 2017 discharge summary states: ¿the patient had been directly admitted for generalized abdominal pain of unclear etiology.All of the above egd, colonoscopy, ct scans and laboratory studies did not help make a diagnosis.Also the patient has no secondary symptoms of severe abdominal pain.She has no nausea, vomiting, no constipation.She does have some diarrhea.She has no leukocytosis or fevers and wants to eat and has her normal hunger without any weight loss.In the hospital when i admitted her on abdominal exam her belly is soft.It is nondistended.There is no voluntary guarding at all with deep palpation.Sometimes when i push and i am talking to her she does not complain of pain until i would tell her, look you are not tender over the hernia and then she would say yes it hurts it is an 8/10.When i talked to the nursing staff in the hospital they have not noticed any severe abdominal discomfort signs but i am concerned as i don't have an etiology.¿ the (b)(6) 2017 discharge summary continues: ¿i did a ct scan that showed her mesh placement that the mesh is in good position.There is no rolled up mesh.There is no meshoma.She has no seroma now.That is completely cleared up and there is expected improvement in the inflammation on today's ct scan compared to a previous exam in january.Her incision shows no signs of infections and there are no infections noted around the mesh.She did have an ovarian cystic lesion so we did a pelvic ultrasound that showed no significant ovarian mass, just a pelvic cyst.All of her laboratory, three evaluations of her wbc are normal.Her lipase is normal.All of her liver enzymes are normal.¿ ¿i am going to send her home on ultram and she has motrin at home.If there is any change in her symptoms i will see her back sooner as i am concerned that she is having pain, i just cannot find an etiology for it despite extensive testing and i am not sure what other testing i can do and with the mesh in good position i don't want to just take her mesh out.If somebody wants to remove her mesh a component separation surgery may be required.¿ records dated (b)(6) 2017 indicate the patient was seen for follow up.¿associated symptoms include abdominal pain, chest pain, coughing, diaphoresis, fatigue, nausea and weakness.[patient] seen in consultation from dr.(b)(6) for abdominal pain.[patient] underwent repair of incisional ventral hernia in (b)(6) 2016 with underlay dual gortex [sic] mesh.Now with severe pain at operative site with slight weakening of fascia.[patient] seen by pain specialist and pain felt to be due to the underlay mesh.¿ abdominal exam notes state: ¿soft.Bowel sounds are normal.She exhibits no mass.There is no tenderness.A hernia is present.Hernia confirmed positive in the ventral area.¿ assessment and plan from the (b)(6) 2017 visit states: ¿abdominal pain due to fascitis secondary to underlay mesh.Recurrent incisional hernia.Plan: repair of recurrent incisional hernia with onlay phasix mesh and removal of old mesh with possible lysis of adhesions.¿ ¿she wishes to proceed with the surgery.She is to attempt to stop smoking since this leads to recurrence and poor wound healing.¿ an operative report dated (b)(6) 2017 indicates the patient underwent ¿open repair of recurrent incisional ventral hernia with only phasix mesh removal of infected mesh.¿ post-operative diagnosis states: ¿abdominal pain ¿ recurrent incisional ventral hernia with associated infected mesh.¿ findings from the procedure state: ¿exploration of the abdominal wall demonstrated an underlay mesh with surrounding edematous changes of the fascia through and through and surrounding tissues consistent with infected mesh.The mesh was completely removed and sent off the field.¿ the (b)(6) 2017 operative report states: ¿a #10 scalpel blade was utilized to make an elliptical incision around the patient's scar from the epigastric region around the umbilicus to the infraumbilical region.The incision was carried down sharply down through subcutaneous tissues down to the underlying fascia.Overlying scar tissue was excised and removed.The subcutaneous tissues were lifted off the fascia bilaterally using electrocautery to [sic] placement of the mesh as well as to identify the previously placed sutures to the underlay mesh.The incision was then opened in the midline through the diastatic tissue.The incision was carried down sharply down to the mesh.The mesh was sharply excised using sharp dissection with metzenbaum scissors and electrocautery from the abdominal wall and from the surrounding underlying omentum and small bowel.¿ the (b)(6) 2017 operative report continues: ¿after completely removing the mesh and all the accompanying sutures, the region was irrigated with normal saline solution.There was no evidence of active bleeding.The fascia was closed using a running suture of #2 prolene from the initial part of the incision all the way down to the infraumbilical region, repairing the hernia.An onlay phasix mesh was placed over the repair and secured to the rectus muscle bilaterally using interrupted sutures of 3-0 vicryl.The region was irrigated once again, no evidence of active bleeding.The midportion of the dermis of the umbilicus was secured to the fascia using interrupted suture of 3-0 vicryl, inverting the umbilicus.The subcutaneous tissues were reapproximated using interrupted sutures of 3-0 vicryl, incorporating the midportion of the mesh to eliminate dead space.The skin was closed using a staple approximator.¿ there was no mention in the operative details of the report that an infection was encountered during the procedure.A surgical pathology report dated (b)(6) 2017 regarding a specimen collected (b)(6) 2017 states: ¿diagnosis: clinical infected mesh, removal: - mesh material with fibrous tissue and mild chronic inflammation.Negative for cytologic atypia or malignancy.¿ ¿gross description: received in formalin labeled with the patient's name and designated "infected mesh" is a sheet of synthetic tan mesh with a small amount of tan membranous tissue on one aspect, measuring 11.5 x 7.0 x 0.2 cm thick.¿ a culture report for the mesh removed on (b)(6) 2017 was not provided.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and 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

Added medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2017: (b)(6).Office notes.Abdominal pain, had incarcerated ventral hernia repaired with mesh (b)(6) 2017 [date discrepancy; (b)(6) 2016].Having epigastric pain before hernia repair and after started having pain at incision site.Was admitted for pain management.Pain is constant, aggravated by movement, no relationship with food, denies nausea or vomiting, no fever, no urinary or bowel issues.Had an egd and colonoscopy, they were normal.Had abdominal aortic surgery few years back, developed hernia from that.Had cholecystectomy and hysterectomy in the past.Is a smoker, complaints of cough, hurts at incision site when she coughs.Went to see her surgeon at the outside hospital, workup was negative, was told her pain could be secondary to adhesions/mesh and she would need another surgery.Medications: aspirin, pletal, plavix.Review of systems: diaphoresis, fatigue, abdominal pain, weakness, bruises/bleeds easily, confusion, nervous/anxious.Exam: weight 162 lb 9.6 oz, bmi 28.8, abdomen; tenderness, no hernias, no palpable swelling.Impression/plan: periumbilical abdominal pain, status post ventral herniorrhaphy, cigarette smoker.Had surgery for incarcerated ventral hernia (b)(6) 2017 [date discrepancy; (b)(6) 2016], had ct scan, showed seroma of three anterior abdominal wall, repeat ct showed resolution of the hematoma.Informed her that adhesion usually do not cause severe pain.Ct did not report any fascial defects/recurrence.Symptoms may improve with second surgery.Repeat surgery will involve removal of old mesh and probable lysis of adhesions.Explained smokers have a higher chance of wound infection and hernia recurrence.Pain may not resolve with surgery if it¿s not from the mesh/adhesions.Should quit smoking for 6 weeks as smoking can lead to flap necrosis and wound infections.(b)(6) 2017: (b)(6).Office notes.Status post repair of recurrent incisional ventral hernia with onlay phasix mesh and removal of infected mesh.Incision clean and intact.Positive diet and bowel movement.Negative swelling.Repair intact.Removed staples.Pathology: clinically infected mesh, removal: mesh material with fibrous tissue and mild chronic inflammation.Negative for cytologic atypia or malignancy.(b)(6) 2017: (b)(6).Office notes.Postoperative visit #2.Having expected abdominal discomfort as she heals.She is happy with the repair.Exam: incision healing well, repair intact, slight tenderness to umbilicus.Doing well.Return to office as needed.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® plus biomaterial use includes warnings and 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

Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2017: (b)(6), md.Office visit.Here for follow up from hospital visit.Had hernia surgery last month.Has a spot that is not healing.Still having right medial pain.Weight 158.44 lbs, bmi 26.78.Abdomen soft, nontender, nondistended, no masses.Give time for healing process, possible referred pain.Patient to dress wound with 2x2; give time for wound to granulate in.(b)(6) 2017: (b)(6), md.Office visit.Here for recent hospital follow up; was admitted for generalized abdominal pain, unknown etiology.Continues to have abdominal pain and states she is unable to bend over or sit straight up for any period of time.Continues to complain of pain on the incision.Continues to smoke; smoking cessation discussed.Weight 159 lbs.Abdomen soft, nontender, nondistended, no masses.Recommended patient follow up with dr.Mcandrew to be referred to gsh for further evaluation of abdominal pain per patient¿s request.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® plus biomaterial use includes warnings and 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

B7: added medical history.H6: 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: on (b)(6) 2014: (b)(6), md.Radiology: ct angiogram abdominal aorta and bilateral iliofemoral runoff with/without contrast.Comparison: ct angiogram abdomen/pelvis on (b)(6) 2010.Small epigastric hernia appearing since last exam contains portion of transverse colon without evidence of obstruction or incarceration at this time.Impression: interval distal abdominal aortic surgical revision with explant previously seen stents.Mild stenosis at approximately 50% luminal narrowing is seen focally at site of prior proximal aspect of stents, most consistent with intimal hyperplasia.On (b)(6) 2016: (b)(6), md.Office visit.Presents with ventral incisional hernia located in lower abdomen; onset 1 week ago.Complaining of a whole bunch of upper abdominal symptoms; loss of appetite, epigastric pain with eating, nausea, vomiting, and gerd [gastroesophageal reflux disease].Went to emergency room with symptoms; identified abdominal wall ventral hernia from previous aortic bifemoral bypass.Does point over hernia site as source of some of her pain; also has dyspepsia type symptoms.Social: occasional alcohol use.Medications: aspirin daily.Weight 166 pounds, bmi 28.05.Abdomen: soft, epigastric tenderness, nondistended.Impression/plan: epigastric abdominal pain of unknown etiology: prior to repair of ventral hernia, recommend egd [esophagogastroduodenoscopy] to evaluate for peptic ulcer disease or gastric mass due to significant gastrointestinal symptoms.Obtain previous abdominal surgery records from (b)(6).Ventral hernia related to previous abdominal aortic surgery; has reducible transverse colon within it.Mildly tender to palpation, partially incarcerated.On (b)(6) 2016: (b)(6), md.Office visit.Postoperative visit status post ventral hernia repair with mesh.Still having some episodic pain.The severe preoperative pain has resolved.Incision healing without difficulty; midline incision well-healed.Abdomen: soft, epigastric tenderness, nondistended.Impression/plan: doing well.Advised no lifting over 20 pounds for 6 weeks.Motrin for pain.On (b)(6) 2017: (b)(6), md.Office visit.Complaint of abdominal pain; onset acute in right lower quadrant when she coughs.Did go to emergency room with right lower quadrant pain; ct scan showed no evidence of recurrent hernia, did show 8 mm small seroma.Generalized abdominal pain and diarrhea.Abdomen: soft, vague generalized tenderness midline incision, laparoscopic trocar sites well-healed.No evidence of recurrent hernia, no rebound, guarding or peritonitis.Impression/plan: no obvious etiology for generalized abdominal pain; only other symptom is diarrhea.Recommend colonoscopy.On (b)(6) 2017: (b)(6), md.Office visit.Complaint of abdominal pain; onset acute and constant in midline abdomen.When last saw on(b)(6), was complaining of right lower quadrant pain and diarrhea.Originally presented with generalized abdominal pain; had an incarcerated upper abdominal hernia defect that had colon within it.Around on (b)(6), i did a primary repair of hernia with mesh.Presented in early on (b)(6) to the emergency room for right lower quadrant pain; repeat ct scan showed complete repair of ventral hernia with a small seroma.Presented to office shortly thereafter with more generalized abdominal pain, diarrhea.Hernia repair was completely intact; recommended colonoscopy due to diarrhea.She canceled this, made her own appointment with gastroenterologist; did egd [esophagogastroduodenoscopy] and colonoscopy that was essentially normal.Patient draws a line across her abdomen from right mid quadrant to left mid quadrant as source of her pain, out lateral to the flanks.Does not look ill; no nausea, vomiting, weight loss, bloating.Abdomen: incision well-healed, soft, nondistended, no rebound, guarding or peritonitis.When i distract her, she has no tenderness to palpation around the incision; when i note she had snow [sic] tenderness, the next time she has significant tenderness when i palpate over incision.No guarding, swelling, or abdominal mass, no hernias.Impression/plan: atypical abdominal pain; etiology has not been identified on ct scan, egd [esophagogastroduodenoscopy], colonoscopy or laboratory values.Did have small 8 mm seroma which i would expect this soon postoperatively.Symptoms seem to be moving and changing; could be due to irritable bowel syndrome.I may not have improved her abdominal pain by repairing incarcerated ventral hernia.Hernia repair intact.Recommended ultrasound of abdominal wall to make sure seroma not enlarging; we could drain this.On (b)(6) 2017: (b)(6), md.Office visit.Presents for follow up for abdominal pain.Ultrasound did show fluid around the mesh measuring about 4 x 3 cm, 9 mm in depth; this is a small seroma; no air or gas bubbles, no obvious signs of infection.Has generalized abdominal pain still; no nausea or vomiting, no significant weight loss despite months of severe abdominal pain.Had severe abdominal pain before surgery to repair ventral incarcerated hernia.Discussed ultrasound findings; offered direct admission to hospital with possible drainage of seroma to see if it helps symptoms; she declined.Current every day smoker; 1 pack/day.Weight 157 pounds.Abdomen: soft, diffuse abdominal tenderness worse in midline, worse when bends over, twists or stands up.No recurrent hernia or abdominal mass.No sign of wound complications or infections.Nondistended, no rebound tenderness.Impression/plan: generalized abdominal pain; had pain before repair of ventral hernia; continues to have same pain across whole entire abdomen.On (b)(6), ct scan showed a small expected postoperative hernia seroma.Today, told me abdominal pain severe and excruciating; offered to admit to hospital; she declined.Offered to treat with high-dose motrin as anti-inflammatory and pain medicine to see if we can settle down any possible pain that may be related to the mesh placement; not sure if this is the cause of her pain.Another possible explanation is she had atypical severe generalized pain prior to the repair of her incarcerated [sic] and may not improve this with the hernia repair; will take motrin.On (b)(6) 2017: (b)(6), md.Brief operative note.Body mass index is 27.3 kg/m2.Preoperative diagnosis: periumbilical abdominal pain.Recurrent incisional hernia with complication.Postoperative diagnosis: periumbilical abdominal pain.Recurrent incisional hernia with complication.Infected mesh.Procedure(s): open repair recurrent incisional ventral hernia with onlay phasix mesh removal of infected mesh.Surgeon(s) and role: (b)(6) md primary.Anesthesia: general.Specimens: id 1) infected mesh.Collected by (b)(6) md.Time on (b)(6) 2017 1437.Destination: pathology.Estimated blood loss: 25 ml from on (b)(6) 2017 1:52 pm to on (b)(6) 2017 3:20 pm.Findings: infected underlay dual mesh.Other information: phasix mesh used in the repair.Disposition/ post procedure course: stable.On (b)(6) 2017: (b)(6) healthcare.Implant record.Mesh phasix cr bard: davol.On (b)(6) 2017: (b)(6).Pathology report.Accession number: sp-17-15317.Diagnosis: clinically infected mesh, removal.Mesh material with fibrous tissue and mild chronic inflammation.Negative for cytologic atypia or malignancy.Clinical information: periumbilical abdominal pain.Recurrent incisional hernia with complication.Routine.Gross description: received in formalin labeled with the patient¿s name and designated ¿infected mesh¿ is a sheet of synthetic tan mesh with a small amount of tan membranous tissue on one aspect, measuring 11.5 x 7.0 x 0.2 cm thick.Representative mesh with tissue is submitted in one cassette.Microscopic description: microscopic examination is performed and the findings corroborate the diagnosis.On (b)(6) 2017: (b)(6), md.Progress note.Postoperative day 1 status post open repair recurrent incisional ventral hernia with onlay phasix mesh, removal of infected mesh.Tolerating clear liquid diet, ambulating hallways.Abdomen: slight distention, dressing intact and dry.Laboratory: white blood cells 18.3, high (4.0-11.0).Impression/plan: change to percocet per patient request.Continue antibiotics.Complete blood count in morning.On (b)(6) 2017: (b)(6) healthcare.Laboratory.White blood cells 8.0, [normal].On (b)(6) 2017: (b)(6), md.Discharge summary.Reason for hospitalization: recurrent incisional hernia.Hospital course/significant findings: underwent repair of recurrent incisional hernia with phasix mesh with removal of infected mesh.Did well postoperatively, diet advanced as tolerated.Discharged home on postoperative day 2.Condition at discharge: good.Disposition: home.Discharge medications: aspirin.Follow up: (b)(6), md; schedule appointment for visit in 10 days.On (b)(6) 2017: (b)(6), rn.Discharge instructions.No lifting greater than 15 pounds for 6 to 8 weeks.Okay to go up and down stairs.Wear binder at all times except when showering.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that 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

Previous patient codes (1930, 3191: appropriate term/code not available for ¿mesh failure¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span august 4, 2010 through august 30, 2017, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Patient information: medical history: hypercholesterolemia hypertension methicillin resistant staphylococcus aureus [mrsa] infection chronic obstructive pulmonary disease [copd] cervical cancer smoker (b)(6) 2008 ¿ 2.5 packs daily (b)(6) 2011 ¿ 1 pack/day (b)(6) 2017 ¿ 30 cigarettes daily x30 years peripheral artery disease fibromyalgia epigastric hernia gastroesophageal reflux disease [gerd] abscess of right breast incarcerated ventral hernia peptic ulcer disease prior surgical procedures: (b)(6) 2010: abdominal-aorta-iliac bypass (b)(6) 2010: aortic aneurysm repair with titanium stent (b)(6) 2011: hysterectomy (b)(6) 2011: cholecystectomy (b)(6) 2016: tubal ligation implant preoperative complaints: (b)(6) 2016: ct abdomen/pelvis: ¿midline ventral hernia containing non-obstructed transverse colon.No evidence of vascular impairment to bowel entering hernia.¿ (b)(6) 2016: ¿obtain previous abdominal surgery records from st.Elizabeth.Ventral hernia related to previous abdominal aortic surgery; has reducible transverse colon within it.Mildly tender to palpation, partially incarcerated.¿ (b)(6) 2016: ¿on last exam i did not note but did identify a ventral partially incarcerated hernia in her midline incision just above umbilicus about size of baseball.No erythema today, hernia unchanged in size.No signs of strangulated hernia.Incisional hernia is partially reducible above umbilicus.We will open this only partially reducible reduce it and fix hernia, may require opening her entire midline incision if she has swiss cheese type of hernia defects.Nonsurgical alternative to leave hernia in place.Would risk strangulated hernia and she would continue with epigastric pain and tenderness.¿ implant procedure: repair of ventral incarcerated incisional hernia with mesh.Implant: gore® dualmesh® plus biomaterial (15269226/1dlmcp03) 10cm x 15cm, oval.Implant date: (b)(6) 2016 description of hernia being treated: ¿i added 500 of vancomycin due to the fact that the patient has had a previous history of mrsa infections.¿ ¿there was a large supraumbilical hernia sac.There were two more ventral hernias, nonincarcerated, below this and then there was a small umbilical hernia.I separated the umbilicus from the fascia.I had healthy infraumbilical fascia with no further herniations identified.I opened up the hernia sac and reduced the colon back into the abdominal cavity.I connected the three ventral hernias and the umbilical hernia creating one hernia defect.I excised some of the denuded tissue of the hernia sac.I cleaned back to healthy fascia.I removed the skin from healthy fascia.There was approximately 5 cm circumferential around the hernia defect.Once i entered the abdominal cavity, i took down adhesions of omentum mainly, a little bit of some small intestine from the anterior abdominal wall.¿ implant size and fixation: ¿i then chose gore dual mesh and i sutured it circumferentially in the abdominal cavity as a sublay with interrupted u-shaped 0 prolene sutures, completely suturing it circumferentially and closing the defect under direct vision to make sure that there was no intestine or omentum coming through the mesh.¿ post-operative period: [two weeks] (b)(6) 2016: ¿incision clean and dry.Staples intact, no signs of infection.(b)(6) is serous we removed (b)(6) today.No significant abdominal pain or tenderness.¿ (b)(6) 2016: ¿still having some episodic pain.The severe preoperative pain has resolved.Incision healing without difficulty; midline incision well-healed.¿ relevant medical information: (b)(6) 2017: emergency room: ¿normal inspection, patient has right lower quadrant tenderness no guarding or rebound.She also has a scar below the umbilical area from recent hernia repair.¿ (b)(6) 2017: ct abdomen/pelvis: ¿interval anterior abdominal wall hernia with mesh placement and postsurgical change.There is a postsurgical seroma abutting the mesh deep to the mesh of about 8 mm thickness.¿ (b)(6) 2017: ¿no obvious etiology for generalized abdominal pain; only other symptom is diarrhea.¿ (b)(6) 2017: ¿around november, i did a primary repair of hernia with mesh.Presented in early march to the emergency room for right lower quadrant pain; repeat ct scan showed complete repair of ventral hernia with a small seroma.Presented to office shortly thereafter with more generalized abdominal pain, diarrhea.Hernia repair was completely intact; recommended colonoscopy due to diarrhea.She canceled this, made her own appointment with gastroenterologist; did egd [esophagogastroduodenoscopy] and colonoscopy that was essentially normal.Patient draws a line across her abdomen from right mid quadrant to left mid quadrant as source of her pain, out lateral to the flanks.Does not look ill; no nausea, vomiting, weight loss, bloating.Incision well-healed, soft, nondistended, no rebound, guarding or peritonitis.When i distract her, she has no tenderness to palpation around the incision; when i note she had snow [no] tenderness, the next time she has significant tenderness when i palpate over incision.No guarding, swelling, or abdominal mass, no hernias.¿ (b)(6) 2017: ct abdomen/pelvis: ¿fluid collection in the deep mid abdominal wall measuring at least 4.6 x 1.5 cm in diameter and 9 mm in thickness.¿ (b)(6) 2017: ¿presents for follow up for abdominal pain.Ultrasound did show fluid around the mesh measuring about 4 x 3 cm, 9 mm in depth; this is a small seroma; no air or gas bubbles, no obvious signs of infection.Has generalized abdominal pain still; no nausea or vomiting, no significant weight loss despite months of severe abdominal pain.Had severe abdominal pain before surgery to repair ventral incarcerated hernia.Discussed ultrasound findings; offered direct admission to hospital with possible drainage of seroma to see if it helps symptoms; she declined.¿ (b)(6) 2017: ¿when i push diffusely she does complain of tenderness but it is not a consistent exam.Sometimes she is tender in the right mid quadrant, sometimes the left mid quadrant especially with distraction.When you are talking with her there is not a consistent abdominal exam.¿ (b)(6) 2017: ct abdomen/pelvis: ¿anterior abdominal wall hernia repair with mesh placement.Resolution of the small seroma demonstrated on the previous study.¿ (b)(6) 2017: discharge summary: ¿she has no nausea, vomiting, no constipation.She does have some diarrhea.She has no leukocytosis or fevers and wants to eat and has her normal hunger without any weight loss.In the hospital when i admitted her on abdominal exam her belly is soft.It is nondistended.There is no voluntary guarding at all with deep palpation.Sometimes when i push and i am talking to her she does not complain of pain until i would tell her, look you are not tender over the hernia and then she would say yes it hurts it is an 8/10.When i talked to the nursing staff in the hospital they have not noticed any severe abdominal discomfort signs but i am concerned as i don't have an etiology.I did a ct scan that showed her mesh placement that the mesh is in good position.There is no rolled up mesh.There is no meshoma.She has no seroma now.That is completely cleared up and there is expected improvement in the inflammation on today's ct scan compared to a previous exam in january.Her incision shows no signs of infections and there are no infections noted around the mesh.¿ ¿i am not sure what other testing i can do and with the mesh in good position i don't want to just take her mesh out.If somebody wants to remove her mesh a component separation surgery may be required.¿ explant preoperative complaints: (b)(6) 2017: ¿having epigastric pain before hernia repair and after started having pain at incision site.Was admitted for pain management.Pain is constant, aggravated by movement, no relationship with food, denies nausea or vomiting, no fever, no urinary or bowel issues.Had an egd and colonoscopy, they were normal.Had abdominal aortic surgery few years back, developed hernia from that.Had cholecystectomy and hysterectomy in the past.Is a smoker, complaints of cough, hurts at incision site when she coughs.Went to see her surgeon at the outside hospital, workup was negative, was told her pain could be secondary to adhesions/mesh and she would need another surgery.¿ ¿informed her that adhesion usually do not cause severe pain.Ct did not report any fascial defects/recurrence.Symptoms may improve with second surgery.Repeat surgery will involve removal of old mesh and probable lysis of adhesions.Explained smokers have a higher chance of wound infection and hernia recurrence.Pain may not resolve with surgery if it¿s not from the mesh/adhesions.Should quit smoking for 6 weeks as smoking can lead to flap necrosis and wound infections.¿ (b)(6) 2017: ¿she exhibits no mass.There is no tenderness.A hernia is present.Hernia confirmed positive in the ventral area.¿ explant procedure: open repair of recurrent incisional ventral hernia with only phasix mesh removal of ¿infected mesh¿ explant date: (b)(6) 2017 ¿overlying scar tissue was excised and removed.The subcutaneous tissues were lifted off the fascia bilaterally using electrocautery to ____ [sic] placement of the mesh as well as to identify the previously placed sutures to the underlay mesh.The incision was then opened in the midline through the diastatic tissue.The incision was carried down sharply down to the mesh.The mesh was sharply excised using sharp dissection with metzenbaum scissors and electrocautery from the abdominal wall and from the surrounding underlying omentum and small bowel.After completely removing the mesh and all the accompanying sutures, the region was irrigated with normal saline solution.There was no evidence of active bleeding.The fascia was closed using a running suture of #2 prolene from the initial part of the incision all the way down to the infraumbilical region, repairing the hernia.An onlay phasix mesh was placed over the repair and secured to the rectus muscle bilaterally using interrupted sutures of 3-0 vicryl.¿ the (b)(6) 2017 operative report does not mention that an infection was encountered during the procedure.Relevant medical information: (b)(6) 2017: ¿white blood cells 18.3¿ [normal 4.0 ¿ 11.0] (b)(6) 2017: ¿white blood cells 8.0¿ conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and 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.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance, tracking, trending and follow-up.Name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 15269226 additional 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)].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

H6: health effect impact code: f26: no health consequences or impact.Previous patient codes (1930, 3191: appropriate term/code not available for ¿mesh failure¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span (b)(6) 2010 through (b)(6) 2017, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Patient information: medical history: hypercholesterolemia.Hypertension.Methicillin resistant staphylococcus aureus [mrsa] infection.Chronic obstructive pulmonary disease [copd].Cervical cancer.Smoker. (b)(6) 2008 ¿ 2.5 packs daily. (b)(6) 2011 ¿ 1 pack/day. (b)(6) 2017 ¿ 30 cigarettes daily x30 years.Peripheral artery disease.Fibromyalgia.Epigastric hernia.Gastroesophageal reflux disease [gerd].Abscess of right breast.Incarcerated ventral hernia.Peptic ulcer disease.Prior surgical procedures: on (b)(6) 2010: abdominal-aorta-iliac bypass.On (b)(6) 2010: aortic aneurysm repair with titanium stent.On (b)(6) 2011: hysterectomy.On (b)(6) 2011: cholecystectomy.On (b)(6) 2016: tubal ligation.Implant preoperative complaints: on (b)(6) 2016: ct abdomen/pelvis: ¿midline ventral hernia containing non-obstructed transverse colon.No evidence of vascular impairment to bowel entering hernia.¿ on (b)(6) 2016: ¿obtain previous abdominal surgery records from st.Elizabeth.Ventral hernia related to previous abdominal aortic surgery; has reducible transverse colon within it.Mildly tender to palpation, partially incarcerated.¿ on (b)(6) 2016: ¿on last exam i did not note but did identify a ventral partially incarcerated hernia in her midline incision just above umbilicus about size of baseball.No erythema today, hernia unchanged in size.No signs of strangulated hernia.Incisional hernia is partially reducible above umbilicus.We will open this only partially reducible reduce it and fix hernia, may require opening her entire midline incision if she has swiss cheese type of hernia defects.Nonsurgical alternative to leave hernia in place.Would risk strangulated hernia and she would continue with epigastric pain and tenderness.¿ implant procedure: repair of ventral incarcerated incisional hernia with mesh.Implant: gore® dualmesh® plus biomaterial (15269226/1dlmcp03) 10cm x 15cm, oval.Implant date: (b)(6) 2016.Description of hernia being treated: ¿i added 500 of vancomycin due to the fact that the patient has had a previous history of mrsa infections.¿ ¿there was a large supraumbilical hernia sac.There were two more ventral hernias, nonincarcerated, below this and then there was a small umbilical hernia.I separated the umbilicus from the fascia.I had healthy infraumbilical fascia with no further herniations identified.I opened up the hernia sac and reduced the colon back into the abdominal cavity.I connected the three ventral hernias and the umbilical hernia creating one hernia defect.I excised some of the denuded tissue of the hernia sac.I cleaned back to healthy fascia.I removed the skin from healthy fascia.There was approximately 5 cm circumferential around the hernia defect.Once i entered the abdominal cavity, i took down adhesions of omentum mainly, a little bit of some small intestine from the anterior abdominal wall.¿ implant size and fixation: ¿i then chose gore dual mesh and i sutured it circumferentially in the abdominal cavity as a sublay with interrupted u-shaped 0 prolene sutures, completely suturing it circumferentially and closing the defect under direct vision to make sure that there was no intestine or omentum coming through the mesh.¿ post-operative period: [two weeks]. on (b)(6) 2016: ¿incision clean and dry.Staples intact, no signs of infection.Jackson-pratt is serous we removed jackson-pratt today.No significant abdominal pain or tenderness.¿ on (b)(6) 2016: ¿still having some episodic pain.The severe preoperative pain has resolved.Incision healing without difficulty; midline incision well-healed.¿ relevant medical information: on (b)(6) 2017: emergency room: ¿normal inspection, patient has right lower quadrant tenderness no guarding or rebound.She also has a scar below the umbilical area from recent hernia repair.¿ on (b)(6) 2017: ct abdomen/pelvis: ¿interval anterior abdominal wall hernia with mesh placement and postsurgical change.There is a postsurgical seroma abutting the mesh deep to the mesh of about 8 mm thickness.¿ on (b)(6) 2017: ¿no obvious etiology for generalized abdominal pain; only other symptom is diarrhea.¿ on (b)(6) 2017: ¿around november, i did a primary repair of hernia with mesh.Presented in early march to the emergency room for right lower quadrant pain; repeat ct scan showed complete repair of ventral hernia with a small seroma.Presented to office shortly thereafter with more generalized abdominal pain, diarrhea.Hernia repair was completely intact; recommended colonoscopy due to diarrhea.She canceled this, made her own appointment with gastroenterologist; did egd [esophagogastroduodenoscopy] and colonoscopy that was essentially normal.Patient draws a line across her abdomen from right mid quadrant to left mid quadrant as source of her pain, out lateral to the flanks.Does not look ill; no nausea, vomiting, weight loss, bloating.Incision well-healed, soft, nondistended, no rebound, guarding or peritonitis.When i distract her, she has no tenderness to palpation around the incision; when i note she had snow [no] tenderness, the next time she has significant tenderness when i palpate over incision.No guarding, swelling, or abdominal mass, no hernias.¿ on (b)(6) 2017: ct abdomen/pelvis: ¿fluid collection in the deep mid abdominal wall measuring at least 4.6 x 1.5 cm in diameter and 9 mm in thickness.¿ on (b)(6) 2017: ¿presents for follow up for abdominal pain.Ultrasound did show fluid around the mesh measuring about 4 x 3 cm, 9 mm in depth; this is a small seroma; no air or gas bubbles, no obvious signs of infection.Has generalized abdominal pain still; no nausea or vomiting, no significant weight loss despite months of severe abdominal pain.Had severe abdominal pain before surgery to repair ventral incarcerated hernia.Discussed ultrasound findings; offered direct admission to hospital with possible drainage of seroma to see if it helps symptoms; she declined.¿ on (b)(6) 2017: ¿when i push diffusely she does complain of tenderness but it is not a consistent exam.Sometimes she is tender in the right mid quadrant, sometimes the left mid quadrant especially with distraction.When you are talking with her there is not a consistent abdominal exam.¿ on (b)(6) 2017: ct abdomen/pelvis: ¿anterior abdominal wall hernia repair with mesh placement.Resolution of the small seroma demonstrated on the previous study.¿ on (b)(6) 2017: discharge summary: ¿she has no nausea, vomiting, no constipation.She does have some diarrhea.She has no leukocytosis or fevers and wants to eat and has her normal hunger without any weight loss.In the hospital when i admitted her on abdominal exam her belly is soft.It is nondistended.There is no voluntary guarding at all with deep palpation.Sometimes when i push and i am talking to her she does not complain of pain until i would tell her, look you are not tender over the hernia and then she would say yes it hurts it is an 8/10.When i talked to the nursing staff in the hospital they have not noticed any severe abdominal discomfort signs but i am concerned as i don't have an etiology.I did a ct scan that showed her mesh placement that the mesh is in good position.There is no rolled up mesh.There is no meshoma.She has no seroma now.That is completely cleared up and there is expected improvement in the inflammation on today's ct scan compared to a previous exam in january.Her incision shows no signs of infections and there are no infections noted around the mesh.¿ ¿i am not sure what other testing i can do and with the mesh in good position i don't want to just take her mesh out.If somebody wants to remove her mesh a component separation surgery may be required.¿ explant preoperative complaints: on (b)(6) 2017: ¿having epigastric pain before hernia repair and after started having pain at incision site.Was admitted for pain management.Pain is constant, aggravated by movement, no relationship with food, denies nausea or vomiting, no fever, no urinary or bowel issues.Had an egd and colonoscopy, they were normal.Had abdominal aortic surgery few years back, developed hernia from that.Had cholecystectomy and hysterectomy in the past.Is a smoker, complaints of cough, hurts at incision site when she coughs.Went to see her surgeon at the outside hospital, workup was negative, was told her pain could be secondary to adhesions/mesh and she would need another surgery.¿ ¿informed her that adhesion usually do not cause severe pain.Ct did not report any fascial defects/recurrence.Symptoms may improve with second surgery.Repeat surgery will involve removal of old mesh and probable lysis of adhesions.Explained smokers have a higher chance of wound infection and hernia recurrence.Pain may not resolve with surgery if it¿s not from the mesh/adhesions.Should quit smoking for 6 weeks as smoking can lead to flap necrosis and wound infections.¿ on (b)(6) 2017: ¿she exhibits no mass.There is no tenderness.A hernia is present.Hernia confirmed positive in the ventral area.¿ explant procedure: open repair of recurrent incisional ventral hernia with only phasix mesh removal of ¿infected mesh¿ explant date: (b)(6) 2017.¿overlying scar tissue was excised and removed.The subcutaneous tissues were lifted off the fascia bilaterally using electrocautery to [sic] placement of the mesh as well as to identify the previously placed sutures to the underlay mesh.The incision was then opened in the midline through the diastatic tissue.The incision was carried down sharply down to the mesh.The mesh was sharply excised using sharp dissection with metzenbaum scissors and electrocautery from the abdominal wall and from the surrounding underlying omentum and small bowel.After completely removing the mesh and all the accompanying sutures, the region was irrigated with normal saline solution.There was no evidence of active bleeding.The fascia was closed using a running suture of #2 prolene from the initial part of the incision all the way down to the infraumbilical region, repairing the hernia.An onlay phasix mesh was placed over the repair and secured to the rectus muscle bilaterally using interrupted sutures of 3-0 vicryl.¿ the on (b)(6) 2017 operative report does not mention that an infection was encountered during the procedure.Relevant medical information: on (b)(6) 2017: ¿white blood cells 18.3¿ [normal 4.0 ¿ 11.0].On (b)(6) 2017: ¿white blood cells 8.0.¿ conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and 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.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 15269226.Additional 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)].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.

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Brand Name

GORE DUALMESH PLUS BIOMATERIAL

Type of Device

MESH, SURGICAL, POLYMERIC

Manufacturer (Section D)

W.L. GORE & ASSOCIATES

flagstaff AZ

MDR Report Key

8217817

MDR Text Key

132091194

Report Number

3003910212-2019-00006

Device Sequence Number

Product Code

FTL

Combination Product (y/n)

PMA/PMN Number

K063435

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

01/04/2019

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

05/31/2019

Device Catalogue Number

1DLMCP03

Device Lot Number

15269226

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Hospitalization; Required Intervention;

Patient Age

49 YR

Patient Weight

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

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