|
W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
| Model Number 1DLMCP04 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Abscess (1690); Unspecified Infection (1930)
|
| Event Date 07/18/2012 |
|
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 open incisional hernia repair on (b)(6) 2011 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2012 and (b)(6) 2013, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: partial removal of gore mesh due to mesh infection, incision and drainage of multiple abdominal abscess, recurrent ventral hernia requiring new mesh for repair, adhesions.Additional event specific information was not provided.
|
| |
|
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: relevant medical information: (b)(6) 2009: (b)(6).Anesthesia record.Weight 97 kg.(b)(6) 2009: (b)(6).(b)(6) md.History and physical.Infected hernia mesh.[illegible] multiple surgeries for hernia.Impression: infected hernia mesh.Plan: wound exploration, removal of mesh (b)(6) 2009.(b)(6) 2009: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: infected hernia mesh with chronically draining sinus tracts midline incision.Postoperative diagnosis: infected hernia mesh with chronically draining sinus tracts midline incision.Procedure: excision of skin, subcutaneous tissue and infected hernia mesh with application of vacuum assisted closure device.Anesthesia: general.Estimated blood loss: 30 ml.Complications: none.Drains: drains consisted of the vacuum assisted closure device.Preoperative evaluation: mr.(b)(6) is 65 years old.He has undergone multiple hernia repairs.By several different surgeons.His most recent repair was several years ago when he underwent a component separation with application of an onlay of prolene.The patient has developed several infected areas which have responded to either local exploration or antibiotic therapy but he is now to a point where he has 3 chronically draining sinus tracts.He is being taken to the operating room for debridement of this area and probable mesh removal.Procedure in detail: ¿after adequate premedication the patient was taken to the operating room and a general anesthetic by way of endotracheal intubation was carried out by the anesthesia department.The patient¿s abdomen was prepped and draped in sterile fashion.The patient had draining sinus tracts which were mostly in the midline in the periumbilical region.There was a wide scar in the area probably measuring about 6-7 cm in its greatest width.This area was excised in its entirety by excising the overlaying skin and the sinus tract in an elliptical fashion carrying dissection down to the area of the fascia.There were several areas of granulation tissue where the prolene mesh was easily identified and was floating off of the tissue in an area of granulation.The skin and overlying subcutaneous tissues were removed.The mesh was also then dissected back to where either the mesh was completely removed and the mesh that was left behind was well incorporated into the tissues and did not appear to be infected.This of course did involve taking some of the anterior abdominal wall fascia.Our options at that time were to undermine the skin and do a primary closure versus application of a vacuum assisted closure device.Because of the underlying infection, we decided to put a wound vac on.A medium size vac sponge was used.It was trimmed to size and placed into the defect.The adherent layer was then placed over the vac and the suction device was placed over the sponge.The suction device was then applied and it was hooked to suction and functioned well.He tolerated the procedure well and returned to recovery room with stable vital signs.¿ (b)(6) 2009: (b)(6) medical center.Microbiology.Abdominal wound culture: few staph aureus.(b)(6) 2009: (b)(6) medical center.(b)(6), md.Pathology.Accession: sg-09-040398.Specimen: abdominal mesh and tissue.Clinical data: infected hernia mesh (abdominal).Gross: received in formalin labeled ¿abdominal mesh and tissue¿ is a 10.0 x 8.0 x 3.0 cm aggregate of surgical mesh surfaced by soft tissues and skin.A representative section of the soft tissue is submitted in one cassette.Final diagnosis: abdominal mesh and tissue, excision: mesh and benign skin with acute and chronic inflammation (clinically infected mesh).(b)(6) 2009: (b)(6) medical center.(b)(6), md.Discharge summary.Discharge diagnosis: infected abdominal wall hernia mesh.He underwent many years ago a cystectomy for bladder cancer, subsequently developed an incisional hernia.He was operated on several times by another surgeon with application of prolene mesh.He ultimately had multiple areas of infection requiring wound exploration several times to have mesh removed.He subsequently underwent a component separation repair with an onlay of prolene several years ago and has done relatively well, but it subsequently began developing recurrent infections.He underwent excision of skin overlying the sinus tracts along with the infected hernia mesh and application of a wound vac today.So far, his postoperative course has been uncomplicated.Home health has been arranged to help him with his wound vac where it will be changed three times a week and i will be following him on an outpatient basis.He is to avoid heavy lifting and straining, not to lift over 20-25 pounds or push heavy objects.He has no dietary restrictions.Discharged on oral medicines and i will be seeing him in a week or two for continued follow up.Call if there are any problems with bleeding, recurrent infection or other issues.(b)(6) 2011: [facility ni].[illegible].Pre-anesthesia evaluation.Weight 93 kg.Asa 3.Current meds: plavix, aspirin.Implant procedure: repair of recurrent incisional hernia with gore-tex underlay.Implant: gore® dualmesh® plus biomaterial [1dlmcp04/8839213, 15 x 9].Implant date: (b)(6), 2011.(hospitalization (b)(6), 2011) (b)(6) 2011: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Anesthesia: general.Assistant: brashear, resident.Estimated blood loss: 75 ml.Complications: none.Drains: none.Preoperative evaluation: (b)(6) is a gentleman who roughly 8 years ago underwent a cystectomy with a medial bladder formation for bladder cancer.Since then, he has had multiple procedures related to incisional hernias.I became involved in the man¿s care in 2006 when i did a component separation-type repair on him using an onlay of ultrapro.Over time the patient has developed a recurrence in the right inguinal area which is getting much larger and is symptomatic.He is being taken to the operating room for a repair.Procedure in detail: ¿after premedication the patient was taken to the operating room.A general anesthetic by way of endotracheal intubation was carried out by the anesthesia department.The patient had sequential compression devices placed on his lower extremities.A foley catheter was placed and the abdomen was prepped and draped in sterile fashion.The patient has had an area of chronic drainage from the old mesh infection in the upper part of his abdomen.These are small 1 to 2 mm opening through which occasionally will protrude some polypropylene mesh.This area was prepped completely out of the field and covered with an ioban and skin incision was made in the inguinal area somewhat higher than the standard inguinal hernia incision and certainly much larger, but it was a transverse incision over this area and was carried out through skin and subcutaneous tissue with hemostasis being maintained with electrocautery.We immediately came in contact with the hernia sac on the hernia.We attempted to keep the hernia sac intact so that we could work extraperitoneal in a stoppa-type of fashion, but because of the nature of the sac and dense-nature of the scarring we found it easier to get into the abdominal cavity and we were able to work through the abdominal cavity to take some adhesions down in the low pelvis with care being taken not to even see his neobladder much less injure it.Several loops of small bowel were taken down sharply.There was no bowel injury during this process.We were able to clear the medial lateral and superior margins in preparation for an underlay.We had to go outside the peritoneum down in the retropubic space.We exposed the cooper¿s ligament, the iliopsoas muscle with care being taken to avoid degenerative femoral and femoral branches.Once this area was exposed a 15 x 19 piece of gore-tex dual mesh was sewn with cv0 of gore-tex to the cooper¿s ligament inferiorly.We then crossed over the femoral vessels and sewed it to the tendinous portion of the iliopsoas using interrupted sutures of cv0 gore-tex.The medial lateral and superior parts of the mesh were secured to the muscle using reverdin needle and cv0 gore-tex placing sutures about a 1.5 cm apart and doing gull-thickness muscle sutures.Once the patch was securely in place the area was copiously irrigated with antibiotic-containing solution.The hernia sac was closed.It was again irrigated.The subcutaneous tissues were closed with interrupted 2-0 vicryls.This area was then again irrigated and the skin was closed with skin staples.The patient tolerated the procedure well.The entire operating time was roughly 3 hours.Sterile dressing was applied.Patient tolerated the procedure well and returned to the recovery room with stable vital signs.¿ (b)(6) 2011: (b)(6) medical center.Implant sticker.Peri-operative nursing record.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp04.Lot batch code: 8839213.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/ 8839213) was implanted during the procedure.Relevant medical information: (b)(6) 2011: (b)(6) medical center.(b)(6), md.Pathology.Clinical data: recurrent hernia.Final: portion of synthetic mesh (1.4 cm) removed from abdominal wall.Specimens submitted: gross description: infected mesh: received in formalin is a 1.4 x 1.2 x 0.2 cm tan-white portion of synthetic mesh material.No sections are submitted, gross only.(b)(6) 2011: (b)(6) medical center.Microbiology.Culture anaerobic.Source: exudate.Abdominal wound culture.Final: moderate finegoldia (peptostreptococcus) magna.Culture extudate/wound/abscess and gram stain.Source: swab.Final: moderate staph aureus.Moderate corynebacterium sp.Occasional strep viridans group.The direct gram stain shows the presence of epithelial cells indicating probable skin flora contamination.(b)(6) 2011: (b)(6) center.(b)(6), md.Radiology ¿ abdomen flat and erect.Clinical indication: hernia repair.Findings: flat and erect views of the abdomen demonstrate moderate gaseous distention of small bowel loops with air noted within the colon and rectum.No free air is seen on this exam.An aortic stent graft is in place.The patient is status post abdominal wall hernia repair.Impression: findings suggestive of an ileus.Partial small bowel obstruction is also a consideration.(b)(6) 2011: (b)(6) medical center.(b)(6), md.Radiology ¿ small bowel follow through.Clinical history: constipation, hernia repair 12/06/11, last bowel movement before surgery.Findings: preliminary scout view of the abdomen reveals numerous stents i grafts throughout the distal abdominal aorta extending into the iliac vessels bilaterally.Abdominal wall retention staples are noted in place.There are multiple distended loops of small bowel seen however there is gas present within the rectum.Impression: slow progression of contrast within the small intestinal tract however, contrast is eventually evident within the colon by 23 hours post oral ingestion.No significant residual small bowel distention appreciated on final image obtained.No extravasated contrast seen.(b)(6) 2011 [assigned]: (b)(6) medical center.(b)(6) res.Discharge summary.Discharge diagnosis: acute on chronic renal insufficiency.Ventral hernia status post repair.Hydronephrosis.Urinary tract infection.Urinary retention.Procedure: laparoscopic ventral hernia repair.Cystectomy with neobladder approximately 8 years ago who ended up suffering from a ventral hernia secondary to the previous incision.Hospital course: patient was admitted, taken to the operating room for laparoscopic ventral hernia repair with gore-tex mesh which he tolerated well.Postoperatively began suffering with what was noted to be worsening renal insufficiency initially from his baseline of 2.Patient went up to approximately 3 in his creatinine.This was noted to be after the patient's foley was removed and the patient noted to develop urinary retention.Urology was consulted along with nephrology who recommended replacing the foley and following his creatinine with a foley in.Of note, the patient does catheterize himself daily preoperatively.After the foley was placed, the patient's creatinine slowly improved back to baseline and urine output drastically improved.Patient also developed a leukocytosis early on where he was started on p.O.Levaquin however, patient was afebrile secondary to what was felt to be a possible urinary tract infection versus pneumonia.His white count at the highest was a 16,000 and down trended after p.O.Levaquin started down to 11.8 yesterday.Patient was hemodynamically stable throughout the hospital course.Also developed an ileus postoperatively which slowly resolved with conservative management.Started on clear liquid diet, advanced to regular diet over the last several days and noted to be tolerating well.Patient has been passing gas, did not have a bowel movement yesterday and this morning.Suppository given and placed on colace and had bowel movement.Patient ready for discharge.Activity: ambulate as tolerated.Continue in and out cath as previously was doing at home.Follow up with dr.(b)(6) in 1-2 weeks.(b)(6) 2012: (b)(6) medical center [assigned].Pre-anesthesia evaluation.Weight 93 kg.Smoker: 1.5 packs/day for >50 years.Asa 3.Current meds: aspirin, plavix.(b)(6) 2012: (b)(6).Office notes.[handwritten].Reason for visit: infected mesh.[illegible].Impression: infected hernia mesh, abdominal wall.Plan: wound exploration, mesh removal (b)(6) 2012.Explant procedure: incision and drainage of multiple abdominal abscesses.Removal of segments of mesh.Explant date: (b)(6) 2012 (hospitalization [ni]).(b)(6) 2012: (b)(6) medical center.(b)(6), md.Operative report.Surgeon: (b)(6), md.First assistant: (b)(6), pgy-4.Preoperative diagnosis: mesh infection.Postoperative diagnosis: mesh infection.Blood loss: minimal, less than 5 ml.Complications: none.Indications: this is a 67-year-old male with a previous ventral hernia repair with mesh, who developed subsequent mesh infections and draining sites.Surgical exploration with possible mesh removal and incision and drainage was indicated and he was scheduled for the procedure.Procedure in detail: ¿after risks, benefits and alternatives were discussed and informed consent was obtained, the patient was taken to the operative suite, laid supine on the operative table.Scds were placed in bilateral lower extremities, dvt prophylaxis, as well as perioperative antibiotics were administered.General anesthesia was administered.The patient was endotracheally intubated.The abdomen was prepped and draped in standard surgical fashion.Patient had several different sites of purulent drainage on the abdomen.The first site, just left of midline, was incised and opened up.There was old mesh which appeared to be infected as well as a fascial staple.These were removed and the area was debrided.Next, moving inferiorly, another site of purulent drainage was identified.This was open in a similar manner and, again, another fascial staple was found and removed.Moving more medially, a 3rd site was identified.We incised this and removed the old mesh and debrided the wound down to the fascial layer and moving just right of midline, a 4th larger area was identified and there was another area superior to this.These 2 draining tracts were connected and splayed open.The skin surrounding this was taken in an elliptical fashion.There was also a staple found in this area, as well as what appeared to be infected mesh.This was all removed with combination of sharp dissection and bovie electrocautery.At the end there were no more tracts draining purulent fluid.The incisions were irrigated and then loosely reapproximated with 2-0 nylon in an interrupted fashion.Sterile dressing was then applied.The patient tolerated the procedure well.There were no complications.All counts were correct at the end of the case times 2.Dr.(b)(6) was present and scrubbed for the entirety of the procedure.¿ relevant medical information: (b)(6) 2012: (b)(6) medical center.(b)(6), md.Pathology.Clinical data: infected mesh abdominal wall.Final diagnosis: mesh and staples from abdomen: benign skin and soft tissue with inflamed granulation tissue identified.Mesh material and staples also grossly identified.Comment: the biopsy findings are consistent with the history of infected mesh.Correlation with culture results is recommended.Specimens submitted: gross description: mesh and staples from abdomen: received unfixed is a 5.5 x 2.2 cm unoriented and disrupted tan skin ellipse excised 1 depth of 1:1 cm.Sectioning reveals a glistening and hemorrhagic red-brown cut surface.Additionally, received in the [illegible] container is 3.5 cm aggregate of roughened tan-red mesh material and four silver metallic staples.Representative secs submitted in one cassette.(b)(6) 2013: [facility ni].(b)(6), md.Office notes.Presents with large diffuse left inguinal left lower quadrant hernia.Becoming symptomatic and going to proceed with repair.Exam: abdomen: soft, nondistended, normal bowel sounds, nontender, no organomegaly.There is a diffuse left inguinal left lower quadrant hernia.Plan: repair of left lower quadrant ventral hernia.(b)(6) 2013: (b)(6).(b)(6), md.Office notes.Returns to clinic for reassessment of multiple medical problems including chronic kidney disease.Needs left inguinal hernia repair this month with dr.(b)(6).Current every day smoker 2 packs per day x 40 years.Current meds: plavix, aspirin.Weight 223 lbs, bmi 31.17.Exam: abdomen: no rebound tenderness and no palpable abdominal masses.Will have hernia surgery in the left inguinal area 2 weeks from today.(b)(6) 2013: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: left recurrent ventral hernia in the inguinal region.Postoperative diagnosis: left recurrent ventral hernia near his left inguinal canal.Repair of recurrent left ventral hernia near inguinal canal with mesh.Mesh used: large prolene hernia system.Indication: this is a 69-year-old gentleman with multiple abdominal procedures in the past including a component of separation as well as a right inguinal and incisional hernia repair.He also had an incision along his left inguinal canal which appeared consistent with a previous left inguinal hernia repair.He is now complaining of a large bulge in his left groin which was near his inguinal canal but also concerning for an incisional hernia.Informed consent was obtained.Risks and benefits were discussed.Operation: ¿the patient was brought to the operating room and placed in the supine position, prepped and draped in the usual sterile fashion.General endotracheal anesthesia was provided.He was given preoperative antibiotics.A time out was performed.We then made a generous incision just above his previous incision along his left inguinal canal.We dissected down through camper¿s and scarpa¿s fascia.However, we did not ever encounter a true external oblique.We did encounter a lower edge of his previous polypropylene, so we encountered this old polypropylene mesh.We also encountered a large hernia sac that was protruding inferiorly at the edge of this previous mesh down towards the inguinal canal.We were able to identify opening of this hernia which appeared to possibly be the internal ring of the patient¿s inguinal canal.However, it was also along his previous mesh.We dissected out the hernia sac as well as opened up the mesh some laterally.Once this was done, once we had the hernia sac mobilized, we determined that we would have to open the hernia sac.Once opening the hernia sac, we determined that it was incarcerated and filled with incarcerated omentum.This omentum was removed in a stat-stat tie-tie fashion.Once it was fully removed, the remaining omentum was reduced back through the defect long with the hernia sac.Once this was done, we determined that a prolene hernia system would fit through this defect as the defect was about the size of the middle ring of prolene hernia system.The posterior leaflet was trimmed some and then placed through our defect and spread.We then placed our anterior leaflet behind the piece of mesh which had been mobilized and down to the pubic tubercle.The 2-0 vicryl was used in an interrupted fashion to attach our anterior leaflet of our prolene hernia system to the pubic tubercle and then along what appeared to possibly be the inguinal ligament, and then also across what possibly was the conjoined tendon.However, our anatomy was very distorted and we were unsure of these exact structures.We did take good bites, though, with good tissue all around the prolene hernia system.The previous mesh was then closed over our prolene hernia system with 2-0 prolene suture in an interrupted fashion.We then closed scarpa¿s tissue with a 3-0 vicry.We then closed the subcutaneous tissue with 3-0 vicryl and closed the skin with a 4-0 monocryl.The patient tolerated the procedure well and was transferred to the pacu in a stable condition.¿ (b)(6) 2013: (b)(6) medical center.Implant record.Peri-operative nursing record.[handwritten].Prolene hernia system (large).(b)(6) 2013: (b)(6) medical center.Anesthesia record.Weight 88.5 kg.Asa 3.(b)(6) 2013: (b)(6) medical center.(b)(6), md.Pathology.Clinical data: llq inguinal hernia.Final diagnosis: omentum, omentectomy: mature adipose tissue, compatible with omentum.Negative for inflammatory infiltrates or malignancy.Specimens: in formalin labeled ¿omentum¿ is a 13 x 7.5 x 4 cm aggregate of lobulated fibroadipose tissue.No mass, lesion identified.Representative sections submitted in once cassette.(b)(6) 2017: (b)(6) medical center.(b)(6).Radiology ¿ initial tumor imaging.History: malignant neoplasm of trigone of bladder.Abdomen: surgical changes from cystectomy and probable neobladder creation are noted without evidence of recurrent hypermetabolic mass however evaluation is significantly limited due to physiologic urinary uptake throughout the bladder.Artifactual postsurgical uptake along the lower ventral abdominal wall hernia mesh is noted.(b)(6) 2017: [facility ni].(b)(6), md.Office notes.Lung mass.Longtime smoker and continues to smoke.Smokes half packs per day for 50 years.History of bladder cancer.Surgical history: abdominal aortic aneurysm repair.Bladder surgery.Hernia repair (b)(6) 2011.I&d of multiple abdominal abscesses, removal of segments of mesh (b)(6) 2012.Prostate surgery.Meds: aspirin, plavix.(b)(6) 2017: (b)(6) general.(b)(6) md.Operative report.Preprocedural diagnosis: history of bladder cancer ileal neobladder and calculus debris of the neobladder.History of multiple recurrent abdominal fistulas.Postprocedural diagnosis: history of bladder cancer with ileal neobladder and calculus debris of the neobladder.History of multiple recurrent abdominal fistulas.Neobladder calculi and foreign body.(b)(6) 2018: (b)(6) general.(b)(6).Discharge summary.Discharge diagnosis: sepsis/sirs secondary to influenza.Urinary tract infection with history of urinary retention requiring intermittent self-catheterization.Chronic obstructive exacerbation due to influenza.Chronic tobacco abuse.On admission heart rate 117, temp 102.4.Tested positive for influenza a in emergency department.Recently saw urologist, called in an antibiotic.He has not begun to take.Started on tamiflu, given azithromycin.Patient admitted to hospital for observation, tamiflu, antibiotics, oxygen and nebulizer treatments.(b)(6) 2018: (b)(6) general.(b)(6), md.Pathology.Fine needle aspiration: positive for malignant cells, compatible with squamous cell carcinoma.(b)(6) 2018: (b)(6) general.(b)(6) history and physical.Medical history significant for chronic obstructive pulmonary disease, squamous cell carcinoma of right lower lung diagnosed 9/17 with radiation treatment at same time.Follow up pet scan showed metastasis to mediastinal lymph nodes biopsy taken (b)(6) 2018 with subsequent radiation therapy ending on (b)(6) 2018.Complaint of acute shortness of breath.Upon arrival to the emergency department patient saturation approximately 76% on nonrebreather and noted to have a large right pneumothorax.Home meds: plavix, aspirin.Past medical history: squamous cell carcinoma right lung radiated 9/17.Bladder cancer approximately 13 years ago with bladder removal and placement of colonic pouch.Prostatectomy approximately 13 years ago.Multiple abdominal surgeries following complications from bladder removal surgery.Chronic obstructive pulmonary disease.Chronic tobacco use.History of abdominal aortic aneurysm.Surgical history: bladder removal with colonic pouch 13 years ago.Abdominal aortic aneurysm repair.Social history: smoking 50-pack year history, 1.5 cigarettes daily.Impression: spontaneous pneumothorax likely secondary to combination of chronic obstructive pulmonary disease, chronic tobacco use, and radiation therapy for squamous cell carcinoma of right lung.(b)(6) 2018: (b)(6) general.(b)(6).Death summary.History of chronic obstructive pulmonary disease, ongoing tobacco abuse, squamous cell carcinoma of right lung diagnosed (b)(6) 2017, status post radiation x2 cycle, hypertension, chronic kidney disease who presented with acute onset shortness of breath found to have right sided secondary spontaneous pneumothorax requiring chest tube placement.Transferred to intensive care unit and subsequently transferred to floor once stabilized.Patient had persistent pneumothorax required second chest tube placement.Expertise from pulmonary medicine, cvt were all gauged and noted that despite being on suction, a leak persisted and it appeared would not resolve.Patient likely developed bp fistula secondary to radiation received to a poor chronic obstructive pulmonary laden lung.After lengthy discussions with family and patient, they elected to go with dnr code status and hospice care if underlying leak did not resolve.Ultimately, patient¿s lung did not improve which led to hypoxic respiratory failure and death at 6:52 pm on (b)(6) 2018.Patient was made comfort care leading up to his death.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 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.".
|
| |
|
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
|
|
H6: updated health effect.H6: updated investigation finding.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® dualmesh® biomaterial plus instructions for use include 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 instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.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 above inherent risks are typically detailed in standard informed consent documents.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.C1: 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.
|
| |
|
Search Alerts/Recalls
|
|
|
