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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/29/2017 |
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Event Type
Injury
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Manufacturer Narrative
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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.".
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2009 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: adhesions to small intestine, adhesions, bowel resection, surgery to remove mesh, fistula, inflammation, chronic abdominal pain, infection, hernia recurrence.Additional event specific information was not provided.
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Manufacturer Narrative
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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: [facility ni] [not indicated].[signature illegible].Pre-anesthesia evaluation.Asa class: 3.(b)(6) 2009: (b)(6) medical center.(b)(6) md.History and physical.48-year-old who complains of upper and lower abdominal pain.Says this is chronic pain that hurts when she is up.Ct scan abdomen/pelvis revealed ventral hernias of lower abdominal wall in area where she had a pfannenstiel incision for hysterectomy several years ago.Also noted to have small umbilical hernia.Surgical history: hysterectomy, dilatation and curettage, tubal ligation, exploratory celiotomy x2 for pain.Medication: nexium, lortab.Social: does not smoke.Weight: 212 [lbs.] abdomen: soft, bulge in lower abdomen just left of midline in left lower quadrant, also one in right lower quadrant that seems to increase with valsalva.They have reduced when she lied down.I cannot feel defects.Impression: lower abdominal ventral incisional hernias, small umbilical hernia.Plan: repair ventral incisional hernias and umbilical hernia.Will do this through a midline incision, so that we would not have any problems with recurrent umbilical hernia when this present.Implant procedure: repair of multiple lower abdominal wall ventral incisional hernias with placement of gore-tex dual mesh.Implant: gore® dualmesh® plus biomaterial [1dlmcp07/(b)(6), 20 cm x 30 cm] implant date: (b)(6) 2009 (hospitalization (b)(6) 2009) (b)(6) 2009: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnoses: lower abdominal ventral incisional hernias.Umbilical hernia.Postoperative diagnosis: multiple lower abdominal ventral incisional hernias.Anesthesia: general.Assistant: (b)(6) md (r).Indication: this is a 48-year-old white female complains of upper abdominal pain and lower abdominal pain.She says this is chronic pain and hurts her when she is up.She has no nausea, vomiting, or diarrhea.She recently had a ct scan of her abdomen and pelvis, which revealed ventral hernias of the lower abdominal wall, where she had a pfannenstiel incision for hysterectomy several years ago.Also, she was noted to have a small umbilical hernia containing omental fat.She presented to the office, was evaluated, and underwent a barium enema which showed a single diverticulum in the distal descending colon.Upper gi with small-bowel follow-through was unremarkable.Ultrasound of her gallbladder was unremarkable.She was therefore scheduled for surgery.Description of procedure: ¿the patient was taken to the operating room under general anesthesia.Foley catheter and orogastric tube were inserted.Abdomen was prepped and draped in appropriate manner.One can feel the hernia in the right lower quadrant and left lower quadrant in the area of the pfannenstiel incision.No umbilical defect could be felt.A lower midline incision was made and carried through the skin and subcutaneous tissue in the peritoneal cavity.There were some adhesions down to abdominal wall and these were taken down.At the umbilicus, no hernia was felt.There were multiple hernia defects all along the pfannenstiel incision.The fascia was markedly attenuated.The fascia was grasped and the anterior abdominal wall was cleaned off.The multiple hernias were opened up the hernia sacs were excised.After much dissection, we had 1 large defect that was about 20 cm x 18 cm.At this point, we felt we needed the piece of dual mesh of 20 cm x 30 cm.Once the anterior abdominal wall was cleaned off completely and the attenuated fascia and hernia sacs were excised, the mesh was placed in the peritoneal cavity.We then took 0 gore-tex sutures, placed through the mesh, brought out through the fascia, and then used a thompson suture passer, went through the fascia to bring up the other end of the suture and tie it.We started superiorly, worked around to the left side.We were careful down in the suprapubic area not to injure the bladder.We worked all around the right side so that the defect was totally closed with the mesh.This took quite some time.We used 0 gore-tex and then had to use 0 prolene sutures.We were careful not to entrap any bowel or puncture the bowel at all.Once this was done, the wound was irrigated thoroughly.Hemostasis was maintained.Some of the fascia superiorly and inferiorly was closed with #1 vicryl running suture, and we closed some fatty tissue over top of the mesh but we still left an area of mesh exposed that was about 4 to 5 cm.So, this was then underlie piece of mesh.Once this was done and wound was irrigated thoroughly, hemostasis was maintained.A 10 flat jackson-pratt drain was placed over the fascia and brought out through a stab wound in the right lower quadrant and secured with a 0 vicryl suture.The subcutaneous tissues was closed with 2-0 chromic running suture.The skin was closed with staples.Sponge and needle count was correct x2.The estimated blood loss was approximately 150 ml.There were no complications.The patient returned to pacu in satisfactory condition.¿ (b)(6) 2009: (b)(6) medical center.Implant sticker.Gore® dualmesh® plus biomaterial.Ref catalogue number: 1dlmcp07.Lot batch code: (b)(6).W.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp07/(b)(6)) was implanted during the procedure.Relevant medical information: (b)(6) 2009: (b)(6) medical center.(b)(6) md.Pathology report.Case #: (b)(4).Final pathologic diagnosis: dense fibrofatty connective tissue showing foci of chronic inflammation and fat necrosis, clinically small ventral hernia and small umbilical hernia.Preoperative/postoperative diagnosis: lower abdominal ventral incisional hernia and small umbilical hernia.Gross examination: in formalin labeled ¿hernia sac¿ is lobulated fatty tissue.Some surfaces of this are smooth and glistening and some surfaces show lobulated fat.It cannot grossly be appreciated that this was a sac-like structure.The tissue aggregates 15 x 8 x up to 1.4 cm in thickness.Obviously, the umbilical hernia sac is not noted.There is an oval portion of tissue measuring 2.3 x 1.5 x 0.3 cm that is firmer than the other portions of tissue.A representative section of it is taken and marked with green ink.On palpating and sectioning the other tissue, there are no lesions noted.Representative portions of the smooth glistening and fatty tissue are submitted in a1 and a2.Microscopic description: sections of the specimen submitted as hernia sac show a dense fibrous connective tissue.There is small amount of skeletal muscle.There is lobulated fat.Within the lobulated fat, there are small foci of fat necrosis.Mesothelial lined surface are not noted.There is no evidence of malignancy.(b)(6) 2009: (b)(6) medical center.(b)(6) md.Discharge summary.Lower abdominal ventral incisional hernias, small umbilical hernia, history of peptic ulcer disease.Hospital course: tolerated procedure well that was done in the form of open ventral hernia repair with mesh placement.Kept nothing by mouth; started on clears after that and tolerated slow advancement of diet.Encouraged ambulating, which she did, pain controlled.Had some vertiginous attack; meclizine resumed.Had surgery on (b)(6) 2009, today is the 26th; afebrile, hemodynamically stable, good oral intake, good urine output.Discharge to follow up with dr.(b)(6) in 2 weeks.Wound dressings clean and dry.Discharge medication lortab.Continue nexium.Activity: no heavy lifting.(b)(6) 2014: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: intrinsic sphincter deficiency.Vaginal mesh erosion.History of chronic back pain.Postoperative diagnosis: intrinsic sphincter deficiency.Vaginal mesh erosion.History of chronic back pain.Procedures performed: exam under anesthesia.Cystoscopy.Resident surgeon: (b)(6) md.Anesthesia: general.Specimens: none.Drains: none.Complications: none immediate.Estimated blood loss: negligible.Indications: ms.(b)(6) is a 53-year-old caucasian woman with a very complicated urologic history.She recalls having incontinence after a motor vehicle accident in 1988 that became progressively worse over time.In 2008 she had an abdominal hysterectomy with burch procedure.She later underwent possibly two retropubic mesh slings, the most recent in 2012.She continued to have severe urinary incontinence.In 2014 she was found to have mesh in the urethra.This was removed via a ventral urethrotomy.At this time she continues to complain of severe urinary incontinence requiring several diapers per day.She notes that she is dry in the supine position but leaks when she stands or does any sort of activity such as bending.On physical exam in the office, dr.(b)(6) thought she was able to palpate residual mesh, however, her exam was truncated due to the patient¿s pain.The risks, benefits, and alternatives were discussed with the patient and she agreed to proceed to the operating room for a cystoscopy and exam under anesthesia in order to have improved operative planning.She also had a ct urogram performed preoperatively due to a history of some sort of renal abnormality.On the ct urogram there appeared to be no upper tract abnormalities.She did appear to have mesh from a hernia repair from the level of the umbilicus to the lower abdomen.There were several areas of small bowel adjacent to the posterior aspect of the mesh.Intraoperative findings: spatulation of the distal ventral urethra with residual 1 to 2 cm of intact proximal urethra.Capacity under anesthesia without purposeful overdistention = 200 ml.Palpable and visible mesh on the left side of the patient¿s urethra, at the distal end of the remaining intact urethra.Tight band of tissue on the left periurethral tissue that was possibly persistent mesh.Normal bladder cystoscopy.Description of procedure: ¿the patient was identified in the preoperative holding area where informed consent was verified.The patient was taken to the operating room and placed on the operating room table in the supine position.She was then placed in the lithotomy position prior to induction of anesthesia to ensure that the positioning would not interfere with her chronic back pain.She was then returned to the supine position where general anesthesia was induced.Perioperative antibiotics were given in the preoperative holding area.Bilateral lower extremity sequential compression devices were applied prior to induction.She was then returned to the dorsal lithotomy position.Her genitalia and perineum were prepped and draped in normal sterile fashion.Timeout was performed identifying the correct patient and procedure to be performed.A weighted speculum was inserted into the vagina.The introitus was small due to atrophic changes and was stretched at the posterior fourchette by the speculum, causing epithelial disruption and mild bleeding.On visual inspection the distal urethra had been spatulated at the 6 o¿clock positions so that the 12 o¿clock position was still intact and the 2 leaflets of the urethra were symmetric.The ventral portion of the urethra was followed posteriorly to identify the remaining intact urethra.The meatus was not leaking urine under anesthesia at rest.However, after placing an index finger through the urethra into the bladder, urine came out around the finger into the vagina.The remaining intact urethra was approximately 1 cm long estimated by palpation.There was a piece of palpable and visible mesh to the left side of the distal end of the intact urethra neomeatus.There was also a tight band of tissue in the left periurethral space that suggested possible residual mesh.Next we placed a 17-french 30-degree female cystoscope per urethra into the bladder.The urethra was inspected and there were no other areas of mesh.The bladder appeared open c/w intrinsic urethral sphincter deficiency.However, the tissue appeared pliable, not excessively scarred or fixed.The urethra was measured by placing the beak of the scope at the bladder neck and a finger at the palpable opening of the intact proximal urethra.The scope ws [sic] removed and the finger between 1 and 2 cm away from the beak of the scope.The bilateral ureteral orifices were identified.There was typical squamous metaplasia of the trigone adjacent to the ureteral orifices.In the midline the trigone appeared white and potentially scarred.She appeared to have normal capacity on visual inspection without any bladder tumors or bladder stones.There were no trabeculations and no other apparent abnormalities on pancystoscopy.The bladder was distended with normal saline to what appeared to be a comfortable level and this amount was measured to be 200 ml.We did not perform a hydrodistention to determine her maximum capacity under anesthesia.With re-evaluation of the bladder after determining capacity there were no glomerulations.The urethra was examined with a 30-degree lens and the bladder was examined with a 70-degree lens.At this point, we had determined sufficient information about how to counsel her in regards to her complicated urologic issues.Also of note, there was a small cystocele and small high rectocele.The patient was then returned to the supine position on the operating room table.A lidocaine urojet was injected into the vagina for local anesthesia on the posterior fourchette.She was then awakened from anesthesia, extubated in the operating room and taken to the recovery room in stable condition.Dr.(b)(6) was present for the entire procedure.Disposition: we discussed with her family the options, which include (1 ) urethral reconstruction with mesh removal and autologous fascial sling placement; with fascia taken from the fascia lata to avoid distorting her abdominal wall, +/- sp tube placement, the main risks being leg pain from the thigh incision, the repair may fail, incontinence may not resolve, and she may have urinary retention, (2) urinary diversion with a conduit; this would be more risky than usual due to the extensive abdominal mesh and the extensive amount of adjacent bowel, which may be adhesed to the mesh and risky to remove, (3) place a percutaneous sp tube and if the incontinence does not resolve satisfactorily, do a later operation either a sling or a bladder neck closure, or (4) bilateral percutaneous nephrostomy tube placement.They will consider the options and she will call with questions and to either make an appointment for one of the above plans, or to make an appointment for a formal conference before proceeding.¿ (b)(6) 2015: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnoses: intrinsic urethral sphincter deficiency, vaginal mesh erosion, splayed urethra.Postoperative diagnoses: intrinsic urethral sphincter deficiency, vaginal mesh erosion, splayed urethra.Procedures performed: pubovaginal sling using autologous fascia lata.A 22 modifier is added because of the extensive scar tissue, friable and splayed urethra and residual eroded mesh, related to her multiple prior surgeries.These factors greatly increased the difficulty of the case and the time involved.A typical autologous fascial sling including fascial harvest takes approximately 2 hours.This procedure took over 3 hours of work by the urology team, even without the fascial harvest, which was done separately by the plastic surgery team.Cystoscopy.Resident: (b)(6) md, pgy-4.2nd assistant: (b)(6) ms-4.Anesthesia: general.Operative findings: abdominal mesh appeared to be too close to the pubic bone for safe placement of a suprapubic tube.Eroded vaginal mesh at the junction between the intact and splayed urethra with surrounding friable tissue.Fascia lata sling harvested by the plastic surgery team.Sling placed under the intact proximal urethra, with difficulty creating the retropubic passage due to scarring from multiple prior surgeries.Cystoscopy showed no bladder injury after passing the sling, no sutures in the bladder, no stones or tumors.Indications: this is a 53-year-old caucasian woman who had several prior pelvic issues including pelvic fracture in a mva 1988, abdominal hysterectomy with burch in 2008, two prior retropubic mesh slings, the most recent in 2012, and in 2014 she was found to have mesh in the urethra, removed by a ventral urethrotomy.She also is s/p abdominal hernia repair with mesh.All of these procedures were done outside uk.Our cystoscopy under anesthesia at uk revealed the distal urethra was spatulated with 1-2 cm of intact proximal urethra, the capacity under anesthesia without purposeful over-distention was approximately 200 ml, there was eroded mesh on the left side of her urethra at the distal end of the remaining intact urethra, there were no stones or tumors.After discussing the options, she decided to have a sling operation with autologous fascia, to place a suprapubic tube at the same time in case her bladder capacity turned out to be so small that she had debilitating frequency, and we consulted with our plastic surgery colleagues for harvesting of the fascia lata because her extensive abdominal mesh would preclude a rectus fascial harvest.Description of procedure: ¿the patient this was identified in the preop holding area, fitted with bilateral sequential compression devices, informed consent was verified, she was taken back to the operating room, given perioperative antibiotics, induced under general anesthesia, placed in the supine position, and the fascia lata graft was harvested by the plastic surgery team and this will be dictated separately.The urology team then took over the case.The patient was repositioned into the dorsal lithotomy position with candy-cane stirrups and re-prepped and draped.Additional antibiotic coverage with vancomycin and gentamycin was provided intravenously.Her previous midline abdominal incision was reopened on its inferior aspect for a distance of approximately 4 cm.Cautery dissection was then carried down to the pubic bone and fascia superior to the pubic bone.At the superior aspect of the incision, there was firm material consistent with her mesh.While it was not definitively exposed, it appeared to be covered by thin tissue so additional antibiotics (iv vancomycin and gentamycin) were given to prevent mesh infection.Also, due to concern that placing a suprapubic tube would increase her risk of mesh infection, it was decided not to place a suprapubic tube.The incision was packed with an antibiotic-soaked laparotomy sponge, and attention was turned to the back table to prepare the sling.On each end of the sling, a #1 prolene suspending suture was passed back and forth, varying the distance between the needle passage and the end of the sling to avoid creating a line of perforations.The sling was then replaced into the basin and covered with a moist gauze until it was placed.Attention was turned to the vagina.A weighted speculum, labial retraction sutures and a lone star retractor were placed.The distal ends of her splayed urethra were also held laterally with 4-0 vicryl traction sutures.The mesh at the distal end of the intact urethra was again identified.It was dissected free of the surrounding tissue using sharp dissection with tenotomy scissors.This was carried back all the way to where the mesh turned to enter the retropubic space.The surrounding tissue was very friable in this area, and while dissecting out the mesh, the mucosa of the splayed urethra was incised laterally.After dissecting the mesh all the way to its entry into the retropubic space, it was not possible to continue dissection so the mesh was left in place until the retropubic space had been entered, anticipating that more mesh may be identified after that maneuver.The dissection for the sling placement was then begun.The incision lines were infiltrated with saline, and bilateral incisions were made starting at the distal end of the intact portion of the urethra and extending proximally and laterally in the vagina, approximately 2 cm proximal to the bladder neck, approximately 1 cm medial to the reflection at the pelvic side walls.The incisions were then extended distally alongside the lateral aspects of the splayed urethra for a distance of 1-2 cm on the patient¿s right side.This was also attempted on the left side, but because the area was already so friable from the inflammation and dissection to remove the sling, and had already been incised laterally including the defect from sling dissection, it was not possible to establish a clear straight incision on this side.To develop the space for sling placement, spreading dissection was carried out from the vaginal incisions laterally along the endopelvic fascia to the junctions of the endopelvic fascia with the pelvic sidewalls bilaterally.We then entered the retropubic space bilaterally using closed curved mayo scissors.This was very difficult due to bilateral scar tissue from her multiple prior pelvic operations and pelvic fracture.It was necessary to scrape the closed curved mayo scissors against the posterior surface of the pubic bone and gradually create a channel for passing the sling.Eventually, this was accomplished bilaterally.Finger palpation confirmed a channel directly along the pubic bone.The eroded mesh was still not palpable in the retropubic space, so it was cut flush with the gu diaphragm at this point.Next, an attempt was made to pass a long clamp through the retropubic space on the patient¿s right side.The initial puncture was made just superior to the pubic bone, approximately 1-2 cm from the midline.Attempting to pass the clamp form above while reaching up through the retropubic space with fingertip guidance, a connection could not be established.Therefore, the clamp was passed from the vaginal side, following the channel created by the closed cured mayo scissors, and was eventually pushed up all the way through the retropubic space, through the abdominal fascia and into the abdominal aspect of the surgical field.The clamp was used to grasp a ¼-inch penrose and withdrawn, bringing the end of the ¼-inch penrose into the vaginal field.One set of sling-suspending sutures was sutured to the penrose, and the penrose was then withdrawn, transferring the sling-suspending sutures to the abdominal field.On the left side, the clamp was used to puncture through the abdominal fascia just superior to the pubic bone, 1-2 cm from the midline.Although it was difficult, eventually it was possible to pass the clamp form the top down under fingertip guidance through the retropubic space and into the vagina, where the other pair of sling-suspending sutures was grasped and pulled into the abdominal field as the clamp was withdrawn.Cystoscopy confirmed there was no prolene in the bladder and no bladder injury, the ureteral orifices were normal.The cystoscope was removed and the foley catheter was replaced.The distal ends of the original 2 vaginal incisions were connected right at the border where the intact vaginal mucosa met the urethral mucosa.This created an inverted u-shaped flap, which was then peeled away from the underlying urethra and bladder using sharp dissection with tenotomy scissors.This dissection was carried 1-2 cm proximal to the bladder neck in order to mobilize enough vaginal tissue to cover the repair.The sling was then secured in place with the distal end at the distal edge of the intact urethra, and the proximal end was just proximal to the bladder neck.This was done with 4-0 vicryl sutures.At this point the decision was considered, whether to proceed with urethral reconstruction to bring the urethral meatus back to its original position.By this time due to the difficulty of the procedure so far with the mesh removal and difficulty in creating the retropubic passages, and also due to the friability and indistinct planes of the urethral mucosa, especially on the patient¿s left side, it was decided to finish the sling, as incontinence was her main bother, and after all of this has healed, to plan a urethral reconstruction to move the meatus more distally at a future date if desired.The vaginal flap was the advanced to cover the sling and it did extend approximately 5 mm beyond the sling.Therefore, its left distal corner was secured to the lateral edge of the previously created left vaginal incision, the a [sic] running locked 2-0 vicryl suture was used to anastomose the lateral edge of the flap to the original vaginal incision, extending proximally to the base of the incision.The residual defect on the left side, where the mesh had been, was then closed with a separate 2-0 vicryl suture.The end of the vaginal flap was then anastomosed to the mucosa at the end of the intact urethra.As this end was more narrow than the urethra, additional sutures were placed to bring the right side of the flap up to approximate with the remaining urethral mucosa up to the 9 o¿clock position of the urethral mucosa.The tissue was flexible enough to accomplish this and then anastomose the remaining right side of the flap to the original right-sided vaginal incision, carrying proximally to the base of the incision.A second 2-0 vicryl suture was used to complete the closure of the vaginal incision adjacent to the urethra on the patient¿s right side.Overall, this appeared to advance the urethra a few millimeters more distally than where it had been before.Attention was turned to the abdominal incision.The right and left pairs of sling-suspending sutures were tied to each other in the midline, holding 2 fingers between the sutures and the fascia so that they would not be tied down too tightly.A stille clamp was then placed into the bladder anterior to the foley catheter, rotated so that the convex portion of the clamp was against the bladder wall, and then the handle was brought anteriorly and cephalad to bring the bladder neck to the vaginal introitus, ensuring that the sling was not over-corrected.The abdominal incision was copiously irrigated with antibiotic solution, and then the subcutaneous tissue was closed with running 2-0 vicryl, and the skin was closed with monocryl subcuticular suture.Estimated blood loss was 100 ml, and there were no immediate complications.The patient tolerated the procedure well and went to the pacu in good condition.I was present for the entire procedure except the final skin closure of the abdominal incision.¿ (b)(6) 2015: (b)(6) healthcare.((b)(6) md.Discharge summary.Admitting diagnosis: urinary incontinence.Reason for hospitalization: cystoscopy revealed distal urethra spatulated with 1-2 cm of intact proximal urethra, mesh on left side of urethra at distal end of the remaining intact urethra.Plan was to do a sling operation with autologous fascia, place suprapubic tube at the same time.Consulted plastic surgery for harvesting of fascia lata because of extensive abdominal mesh would preclude a rectus fascial harvest.Hospital course: surgery (b)(6) 14; planned suprapubic tube not placed because it appeared that the abdominal mesh would be too close to the tube site and would increase risk of mesh infection.The mesh was dissected out and removed at the level of the genitourinary diaphragm.Sling placement was very difficult and the distal urethral tissue was very friable, so decided not to perform urethroplasty at that time.No immediate complications.Postoperative day 1, started on regular diet, encouraged ambulation; ambulated with some assistance.As of now, tolerates regular diet, voids with foley catheter, has bowel movement, ambulates, pain well-controlled by oral medications.Will leave thigh dressing in place for 1-2 more days, ok to shower.Follow up urology clinic (b)(6).Instructions: no lifting more than 10 [lbs.] for 20 days.Move around as able.(b)(6) 2017: (b)(6) healthcare.(b)(6) md.Operative report.Pre/postoperative diagnoses: urge urinary incontinence.Nocturia.Procedure: incision and placement of left electrode array for sacral nerve stimulatory (stage i placement).Complications: none.(b)(6) 2017: (b)(6) uk healthcare.(b)(6) md.Operative report.Pre/postoperative diagnoses: urge urinary incontinence.Nocturia.Sacral nerve stimulatory stage i placement (b)(6) 2017 with no improvement in symptoms.Procedure: removal of stage i sacral nerve stimulator.See attachment for h10/11 continuation.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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: the medical records include the following medical history: (b)(6) 2019: ¿diabetes mellitus¿.Gastroesophageal reflux disease [gerd].(b)(6) 2019: enterocutaneous fistula.(b)(6) 2019: ventral hernia, recurrent.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.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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Manufacturer Narrative
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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.Through gore's investigation and based on the available information 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus biomaterial 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.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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.
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