| Device Problems
Contamination (1120); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240)
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| Event Date 01/10/2007 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible 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.¿.
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2001 whereby an alleged gore device was implanted.The complaint alleges that on (b)(6) 2002, the patient again underwent open incisional hernia repair whereby a gore dualmesh® plus biomaterial was implanted.It was reported that an additional procedure was performed on (b)(6) 2007 whereby the gore devices were explanted.It was reported the patient alleges the following injuries: abdominal pain and discomfort, hernia recurrence, extensive adhesions, mesh infection, and mesh removal.Additional event specific information and medical records were not provided but have been requested.
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Manufacturer Narrative
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Other relevant history: added patient medical history.Adverse event problem: corrected conclusion code.Added medical record summary.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2001, including those detailing any previous abdominal surgical procedures, were not provided.Operative records dated (b)(6) 2001 indicate the patient underwent attempted laparoscopic repair of an incisional hernia, followed by open repair.The records state: ¿the patient presented to my office with a bulge at the upper portion of a previous midline incision.It was obvious that she had an incisional hernia.¿ the (b)(6) 2001 records state: ¿the fascia was incised and the muscle was pulled superiorly and inferiorly.The transverse abdominis muscle was then encountered and opened but i really could not find my way into the abdominal cavity.I drew up on a piece of tissue that i thought might be the peritoneum, although it seemed rather thick.I made a small, very shallow incision in it but it bled so i though[t] that it might, in fact, be bowel wall, so i closed the little nick with a 4-0 suture.Further exploration did not yield an obvious opening into the peritoneal cavity initially.Finally, we found our way into the peritoneal cavity and introduced the scope after insufflating the abdomen.We found that the omentum was adherent across the entire expanse of the abdomen and several loops of small bowel were stuck up under the omentum.Thus, we really could not see the anterior abdominal wall.I, therefore, decided that a laparoscopic approach to this particular hernia was not going to be possible and decided to fit it with open technique.¿ the (b)(6) 2001 records continue: ¿an upper midline incision was then opened from the top of the incision which was about 2.5 inches above the umbilicus down to a little ways past the umbilicus.Dissection was carried down into the hernia sac.We dissected out the entire area and found three separate hernias.The largest one was in the midline and was about 3 cm long.There was one lying off to the right which was about 15 mm in size and one lying a little bit more inferiorly on the midline which was about 12 mm in diameter.I dissected the fast off the anterior fascia and dissected the adhesions of the omentum off the inside of the fascia and then placed a gore-tex mesh.This was a circular piece of mesh about 10 cm in diameter.Sutures were placed on the right and left and superiorly and inferiorly.The suture was brought through the fascia, through-and-through the mesh and then back up through the fascia.After these 4 sutures were placed, the knots were tied down, approximating the mesh to the back of the fascia of the abdomen.The defects themselves were then closed over the top of the mesh with the sutures incorporating a bit of the mesh.The midline incision was closed with vertical mattress suture of 3-0 nylon.The incision on the right side was closed at the fascia level with prolene and at the skin level with subcuticular 4-0 vicryl.¿ product identification records for the alleged ¿gore-tex mesh¿ were not provided.Operative records dated (b)(6) 2002 indicate the patient underwent treatment of an incisional hernia.The records state: ¿mrs.Lytle has had procedures to the midline to treat endometriosis and bowel obstructions.She developed an incisional hernia, which i first dealt with a year ago.She then returned to see me with an uncomfortable bulge above the area where the previous operation had been done.I thought i placed a mesh at the top of the incision, but obviously the incision came up a little higher, and she had an incisional hernia at the top of the old incision.I suggested repair.¿ the (b)(6) 2002 records state: ¿the patient was placed in a supine position, and general anesthesia was induced.The abdomen was prepped and draped in the usual fashion.An incision was made extending over the top 1" of old incision, and then above onto previously unincised abdominal skin for another 1".Dissection was carried down on to a very sharply circumscribed midline fascial defect which was about 12 mm in diameter.On dissecting beneath the fascia, i found the upper edge of the gore-tex just a few millimeters inferior to the area of the present hernia.The overlying subcutaneous fat was dissected away, and i then placed another piece of gore-tex to repair this defect.0 prolene was used, the stitch was taken through the fascia, through and through the gore-tex, and then back up to the fascia.The piece of gore-tex was cut in an octagonal shape and was longer from right to left than from top to bottom.From right to left, it was about 6 cm, and from top to bottom it was about 4.0 to 4.0 cm.Stitches were placed circumferentially at the top, bottom, right and left.After all sutures were placed, the mesh was pulled up against the back of the abdominal wall.The lower stitch went through the old piece of gore-tex and then through the new piece.We made sure that the gore-tex was lying against the back of the abdominal wall, and that the corrugated side of the mesh was up against the back of the abdominal wall.After trying down all of these prolene sutures, the defect itself was approximated with figure-of-eight suture of 0 prolene which incorporated the underlying gore-tex in the stitch.Skin was closed with continuous vertical mattress 3-0 nylon.¿ product identification records for the alleged ¿gore-tex¿ device were not provided.There is no mention of infection and no mention of gore device removal.Records between (b)(6) 2002 and (b)(6) 2006 were not provided.Operative records dated (b)(6) 2006 indicate the patient underwent exploratory laparotomy, rectosigmoid resection, and lysis of extensive intraabdominal adhesions.Postoperative diagnoses state: ¿lower abdominal pain.Diverticulosis.Extensive intraabdominal adhesions.¿ the records state: ¿the patient is a 50-year-old black female, with difficulty moving her bowels and pain with defecation and found to have localized symptomatic diverticular disease in the lower sigmoid colon.¿ the (b)(6) 2006 procedure notes state: ¿the skin and subcutaneous tissue were sharply undermined, along with the fascia and the patient's incisional hernia or mesh, which was incised longitudinally and the abdominal cavity was then entered and the patient was found to have extensive intraabdominal adhesions and the next two hours of the operation, greater than 80% of the operating time was then devoted to lysing adhesions, which were densely adherent to the patient's pelvis, between the small bowel, the omentum, loops of small bowel to the rectosigmoid colon.The splenic flexure was then widely mobilized under direct visualization in order to gain length into the pelvis and the lateral colonic attachments divided along the pericolic gutter using electrocautery and sharp and blunt dissection, electrocautery for hemostasis until the rectosigmoid colon was loosened from its distorted, twisted state in the left side of the pelvis.¿ the (b)(6) 2006 records continue: ¿this was freed up and ureters were easily identified and the descending colon was then divided using gia-stapler and the mesocolon was then divided serially using a ligasure device, down to the mid rectum, where the rectum was divided using gia-stapler and a side to side functional anastomosis was then created using the gia-stapler and coloproctostomy was then sewn in two layers using a running 4-0 prolene suture and a running lembert fashion suture and the anastomosis was seen to lay easily, without tension in the left lower pelvis and the abdomen was then thoroughly irrigated and aspirated.A blake drain was brought in through the left lower quadrant through a separate stab wound, placed in the pelvis.A sheet of seprafilm was placed in the pelvis and the omentum was widely mobilized and the omentum was then laid, replaced in the abdominal cavity and a piece of seprafilm was then placed on top of the omentum, under the incision, which was then closed using a running suture of #1 prolene.Skin was closed using staples.¿ there is no mention of infection and no mention of gore device removal.Operative records dated (b)(6) 2007 indicate the patient underwent wound exploration and removal of infected hernia mesh.The records state the patient is "status post left colectomy with incisional subsequent herniorrhaphy with mesh with persistent wound drainage from the mid portion of her incision undergoing wound exploration.¿ the (b)(6) 2007 records state: ¿the skin and subcutaneous tissue were sharply entered down to the level of the fascia on top of this where the patient was noted to have an infected mesh which was circumferentially removed in its entirety and along with several loose #1 prolene sutures.After this was accomplished, granulation tissue was cauterized and removed.The wound was packed open, and the wound was terminally anesthetized using 0.5% marcaine, packed open with dry gauze.The patient was taken to the recovery room in stable condition having tolerated the procedure well.¿ operative records dated (b)(6) 2007 indicate the patient underwent recurrent incisional herniorrhaphy.The records state: ¿the patient is 50 -year-old obese black female that smokes who noted to have status post left colectomy having had previous incisional herniorrhaphy with mesh now with recurrence of same status post excision of infected mesh for repair and re -closure of ventral hernia.¿ the 2/28/2007 records state: ¿after the abdomen was prepped and draped in usual sterile fashion, the patient's previous midline incision was excised from the superior border down to approximately 6 cm below the umbilicus to the level of the horizontal abdominal crease.The skin and subcutaneous tissue were widely incised down to the level of the fascia.The patient was noted to have a midline ventral hernia, which was entered, and the fascia was then circumferentially opened for its full extent to reveal the underlying defect.The patient additionally was noted to have a right-sided superior defect as well.This was all incorporated into one large opening, which measured approximately 18 x 12 cm and was circumferentially freed from omental adhesions laterally, superiorly, and inferiorly.Inferior incision was palpably intact, and at this point the subcutaneous tissue was divided away from the fascia superiorly so that the fascia was freed for a distance approximately 4-6 cm circumferentially.¿ the 2/28/2007 records continue: ¿at this point, a collamend mesh which measured 6 x 8 inches was then brought in after being soaked in saline for several minutes ahead of time, was brought into the incision and trimmed to appropriate size in an oval fashion, circumferentially attached to the fascia with interrupted sutures of #1 prolene, and placed through the fascia in a circumferential fashion under direct visualization.The mesh was then finally trimmed to appropriate size and redundant mesh was removed.Several interrupted sutures of fascia were placed to bring the somewhat redundant fascia across the top of the repair loosely, and a 7 mm blake drain was brought in through a separate right lower quadrant stab wound.The subcutaneous tissue was then reapproximated using running 2-0 vicryl suture, and the skin was closed using staples.¿ 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible 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.¿ 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: records from 1990 indicate the patient was seen for recurrent left flank pain and underwent a ureteral stent placement.Records dated (b)(6)1991 state: ¿thirty-four year old female patient carries a diagnosis of irritable bowel syndrome with ulternating [sic] bouts of constipation and diarrhea.For the past few months the patient has been having left lower pain, which is becoming more constant and severe.¿ records dated (b)(6)1991 indicate a ct was performed for ¿abdominal pain.[history] of carcinoma of the uterus.¿ ¿in the pelvis, one does note in the midline what appear to be some cluster of bowel loops with perhaps somewhat thickened walls.This is apparently immediately under the previous operative site and these changes probably represent benign adhesions rather than metastatic disease.¿ ¿impression: 1.Status post hysterectomy.2.Probable adhesions with somewhat thickened bowel loops in the anterior pelvis¿¿ the (b)(6)2002 records continue: ¿after all sutures were placed, the mesh was pulled up against the back of the abdominal wall.The lower stitch went through the old piece of gore-tex and then through the new piece.We made sure that the gore-tex was lying against the back of the abdominal wall, and that the corrugated side of the mesh was up against the back of the abdominal wall.After trying down all of these prolene sutures, the defect itself was approximated with figure-of-eight suture of 0 prolene which incorporated the underlying gore-tex in the stitch.Skin was closed with continuous vertical mattress 3-0 nylon.¿ product identification records for the alleged ¿gore-tex¿ device were not provided.There is no mention of infection and no mention of gore device removal.Records between (b)(6)2002 and (b)(6)2004 were not provided.Records dated (b)(6)2004 state the patient was seen for ¿complaints of mid abdominal pain with bouts of diarrhea.The pt notes that this has been persistent for three months¿¿ records dated (b)(6)2004 state: ¿pt is sp colonoscopy which failed to demonstrate any abnormalities.The pt still complains of some crampy abd pain and multiple bowel movements with uncertain etiology at this point.¿ ¿the pt had similar symptoms which dated back to 1991 by ct scan at tci.¿ ct scan records dated (b)(6)2004 state: ¿evidence of abdominal hernia repair along the ventral abdominal wall is seen.There is clip in the left adnexal region related to prior surgery.Impression: no definite acute intra-abdominal process.Postsurgical changes as above.¿ there was no mention of the mesh in the records.Records dated (b)(6)2004 state: ¿pt is seen today sp ct scan demonstrating no discrete finding or any evidence of bowel thickening.The pt chart is reviewed and the pt has had similar symptoms dating back at least to 1991.The pt has been on bentyl, but has never been on zelnorm for her diarrhea or her crampy abd pain.¿ records dated (b)(6)2005 state: ¿pt is seen today for ongoing complaints of crampy abd pain.She is sp colonoscopy which failed to demonstrate any abnormalities.¿ records dated (b)(6)2006 state: ¿this is a 49-year-old obese black female seen approximately two years ago with complaints of left lower abdominal pain and irregular bowel movements and now with some rectal bleeding.Patient notes that the rectal bleeding is somewhat new.¿ ¿assessment/plan: patient with left-sided lower abdominal pain going on for several weeks.Plan is for repeat colonoscopy and evaluate the source of rectal bleeding which may be hemorrhoids or possible diverticulosis.¿ records dated (b)(6)2006 state: ¿pt is sp be which demonstrated sigmoid and descending diverticular disease.The pt continues to have pain on her left side of her abdomen and lower abd which is likely secondary to the same.It is recommended to the pt that she have a low anterior resection¿¿ records dated(b)(6)2006 state: ¿pt is sp low anterior resection for a diverticular disease.The pt¿s wound has as small amount of serous drainage in it but is otherwise healing well.Pt¿s staples are removed¿¿ records dated (b)(6)2006 state: ¿the wound is healing very nicely and pt has a small opening measuring 2 x 1 cm which is probed and cleaned with a q-tip.¿ records dated (b)(6)2006 state: ¿the pt¿s wound continues to drain and now with somewhat seropurulent material which was not present since her last ov and the pt¿s wound is otherwise well healed and somewhat sealed up in her upper and lower portion of her midline and these areas are probed with a q-tip packed with dry gauze¿¿ records dated (b)(6)2006 state: ¿pt is sp left colectomy and pt has a wound infection which looks markedly improved today and the superior opening has completely closed.Inferiorally the pt¿s wound has a 1x1x2 cm opening inferiorally and at this point the pt still has some sero purulent drainage from this¿¿ records dated (b)(6)2006 state: ¿pt returns today for evaluation of ongoing complaints of abdominal pain and pt¿s lower midline wound is nearly completely healed and pt has good granulation tissue which is cauterized.¿ records dated (b)(6)2006 state: ¿pt is returns [sic] today for wound evaluation and pt has ongoing difficulty with persistent drainage from two areas which have drained before.The superior one skin closed and this is probed again and drained of serosanguineous fluid and there is no evidence of erythema, induration or cellulitis.At this point the pt is to be started on bactrim ds¿.And should this fail to resolve some of this infection and drainage than [sic] pt may require wound exploration¿.¿ records dated (b)(6)2006 state: ¿pt is seen today in f/u for evaluation of persistent wound drainage just above and just inferior to the level of the umbilicus.Both wounds are probed and pt continues to have drainage from the incision.Plan at this time is for wound exploration as pt behaves as she has a wound seroma and or granuloma which refuses to resolve.¿ records dated (b)(6)2007 state: ¿pt is sp removal of infected ventral hernia mesh.Pt has a superior upper midline right sided incisional hernia as well which continues to persist and is moderately symptomatic but reducible.Pt is moving her bowels and eating without difficulty.Pt at this point still complains of abdominal wall pain but her wound measures approximately 6 cm in length and 3.5 cm in width and is pink granulating in nicely.There is no evidence of any erythema, induration or cellulitis.¿ records dated (b)(6)2007 state: ¿pt is seen today in f/u after removal of her infected mesh.Her wound inferiorally has healed nicely and superiorally the pt has drainage from a second subcutaneous abscess and has some pink granulation tissue.Plan at this point is for exploratory laparotomy and scar removal and repair of incisional hernia with collamend mesh under general.¿ records dated (b)(6)2007 and (b)(6)2007 state the wound was healing well and staples were removed.Records dated (b)(6)2007 state: ¿pt is having a great deal of serous drainage from the lower portion of her incision which started this morning and the wound is probed and the pt has some mild inflammatory changes of the subcutaneous tissue surrounding this¿¿ records dated(b)(6)2007 state: ¿the wounds are healing well and pt has a small collection in the upper portion of her incision which is opened and relieved or approximately 5 ml of serous fluid.¿ records dated (b)(6)2007 state: ¿the wound is healing well with the exception of a small opening inferiorally and this is open for a distance of 2.5 cm after injecting the skin and soft tissue with 1% xylocaine and packed with dry gauze.¿ records dated (b)(6)2007 state: ¿pt is sp i&d and re-opening of her midline wound from her an [sic] incisional herniorrhaphy with bioprosthetic mesh.The wound has minimal drainage at this time and is re-propped with a q-tip.¿ records dated (b)(6)2007 state: ¿pt seen today with some persistent but lessening drainage from her midline incisional wound which is probed and as a small area opening and erythema and induration.¿ records dated (b)(6)2007 state: ¿the pt has no signs of infection but does have some right sided upper abdominal pain with a questionable mass in the right upper portion of her abdomen.Pt has no signs of cellulitis, erythema or induration.¿ ct records dated (b)(6)2007 state: ¿subcutaneous induration in the midline adjacent to the anterior aspect of the lower abdominal wall which is probably due to recent surgery.The study is otherwise unremarkable.¿ records dated (b)(6)2007 state: ¿pt is seen today in f/u with complaints of ruq right superior para incisional pain and mass.The pt did have a separate hernia repair at the time of her previous incisional herniorrhaphy with mesh and pt has had a recent ct scan of the abdomen and pelvis which failed to demonstrate any repeat abdominal wall mass, abscess or hernia or abnormality apart from midline scar tissue which is to be expected.¿ records dated (b)(6)2007 state: ¿pt is seen today after repeat ct scan demonstrates no inflammatory changes but postop changes in the right upper portion of her abdomen.There is no evidence of any infection, abscess, recurrent incisional herniation or foreign body in her anterior abdominal wall.The pt¿s wound and interior abdominal wall exam are otherwise unchanged.Pt is complaining of patch like hipesthesias in the right upper superior portion of her midline wound just lateral to the incision on the right side which shows no evidence of any cellulitis, erythema or induration or recurrent hernia.At this point the pt notes that she had a local topical skin reaction to the lidoderm patches.Records dated (b)(6)2007 state the patient was seen for ¿abdominal pain and back pain.She describes the pain as achy and sharp in nature.She states that this has been bothering her since last february.She states the pain is there most of the time, and nights are worse in relation to pain.She rates her pain as 9/10 in the office today and states that twisting and moving worsen the pain.¿ records dated (b)(6)2007 state: ¿pt is seen today in consult from dr.(b)(6) and has noted that she has been losing weight and began having abdominal pain and diarrhea.¿ ¿the patient complains primarily of pain in the ru abdomen.Records dated (b)(6)2007 state: ¿pt is seen today in f/u sp incisional herniorrhaphy with mesh.The pt notes that she had recently had a cold and coughing spell and complains of right sided abdominal pain.¿ ¿exam demonstrates a well healed midline incision with a right upper abdominal incisional recurrent hernia which is easily palpable just to the right of her upper right midline wound.¿ operative records dated (b)(6)2008 state the patient underwent recurrent incisional herniorrhaphy with mesh.¿the patient is a 51-year-old black female status post left colectomy with a recurrent upper right-sided abdominal incisional hernia from just lateral to the right side of midline.¿ ¿an 8 cm incision was made directly overlying the fascia defect approximately 4 cm lateral to the midline in the upper right side of the previous midline incision.The skin and subcutaneous tissue were sharply entered at the level of the fascial defect, and the peritoneum was then incised and opened.The fascial edges were identified circumferentially noting a fascial defect measuring approximately 3.5 x 3.5 cm.At this point, a bard ventralex tabbed mesh was then chosen for the repair and circumferentially attached to the fascial edges with interrupted sutures of #1 prolene with good secure closure after hemostasis was judged to be adequate, and the wound was then terminally anesthetized using 0.5% marcaine and subcutaneous tissue was then reapproximated using running suture of 2-0 vicryl.Skin was closed using staples.¿ records dated (b)(6)2008 state: ¿her wound is healing well and staples are removed.¿ records dated (b)(6)2008 state: ¿the wound is healing well and staples have been removed at the last ov.Records dated (b)(6)2008 state: ¿pt returns today for evaluation of her incisional hernia which is healing well.There is no evidence of erythema, induration or cellulitis.Pt is to stop scratching her skin and has no cellulitis at this time and pt has been using benadryl cream.¿ records dated(b)(6)2008 state: ¿the wound is well healed pt is till [sic] complaining of abdominal pain and multiple bouts of diarrhea¿¿ records dated (b)(6)2009 state: ¿pt is seen today with ongoing complaints of abdominal wall pain and some prior [history of] drainage from her lower midline incision which is now stopped.The pt has previously had incisional herniorrhaphies with mesh.¿ ¿pt notes historically that pain became acutely exacerbated after she had to lift her father after he collapsed on the stairs.¿ ct records dated(b)(6)2009 state: ¿ct abdomen shows no hepatic or pancreatic mass.Postoperative changes in the anterior abdominal wall with small ventral hernia containing unobstructed loop of small bowel.¿ records dated (b)(6)2009 state: ¿pt returns today with ongoing complaints of mid abdominal pain and with a unobstructed loop of small bowel that was seen on recent ct scan.The pt is still having complaints of diarrhea and wishes to hold off on any surgical intervention for repair of her recurrent incisional hernia until later in the summer¿¿ records dated (b)(6)2009 state the patient underwent recurrent incisional herniorrhaphy with mesh.Postoperative diagnosis states: ¿recurrent incisional hernia x3.¿ ¿the patient is a 52-year-old obese black female with copd and with multiple recurrent incisional hernias for the same at the superior end of her incision, now for repair with mesh.¿ the (b)(6)2009 operative records state: the upper 10 cm of the patient¿s midline incision was incised after the original scar from this portion was excised.Skin and subcutaneous tissue were sharply divided down to the level of the fascia, where a small, approximately 2 x 2 cm incisional hernia was found to the right of midline superiorly.The abdomen was then entered and the fascia was circumferentially dissected under direct visualization using sharp dissection to reveal 2 additional 2 x 2 cm incisional hernias which were in the midline and to the left of midline as well.Each of these was incorporated into the total defect, and the fascia was then opened for a distance of approximately 8 cm.Lysis of adhesions then occurred circumferentially between the peritoneum and the underlying omentum.This was then circumferentially freed from adhesions for a distance of approximately 10 cm.At this point the fascial edges were freed from subcutaneous fat circumferentially for a distance of approximately 10 cm as well, and the defect was then repaired using a piece of proceed mesh which measured approximately 8 x 10 cm.This was circumferentially attached under direct visualization with 0 prolene.These sutures were placed in interrupted fashion circumferentially under direct vision.¿ records dated (b)(6)2009 state: ¿pt is sp incisional herniorrhaphy with mesh for a recurrent incisional hernia.Pt¿s wound is healing well and staples are removed.¿ records dated (b)(6)2009 state: ¿pt is sp incisional herniorrhaphy with mesh.The wound is healing well and pt states she had drainage of what sound to be a seroma but there is no evidence of any opening along her incision.¿ records dated(b)(6)2009 state: ¿pt is sp recurrent incisional herniorrhaphy with mesh.The wound is healing well and pt had drainage of a seroma inferiorally but no evidence of any cellulitis, erythema or induration.¿ records dated (b)(6)2009 state: ¿patient comes in today and notes that she has starting [sic] bowling recently and had some pain on the left side of her abdomen.The pt also notes she had a recent episode of some [nausea/vomiting] with some diarrhea.Pt notes that she has had a slight bulge to the left side of her abdominal wall incisional hernia repair which has persisted over the last several weeks and causes local compressive symptoms and some pain especially when she was bowling in her league.Pt was seen by dr.(b)(6) for copd and pulmonary issues.¿ ¿assessment/plan: pt with recurrent incisional hernia.Plan is for repair of same.¿ operative records dated (b)(6)2009 indicate the patient underwent recurrent incisional herniorrhaphy with mesh.¿the patient is a 53-year-old obese black female who smokes status post midline incision for colonic resection.She was found to have a recurrent incisional hernia in the left upper quadrant at the edge of her mesh causing local irritation and compressive symptoms.¿ ¿¿an 8-centimeter longitudinal incision was made in the left upper quadrant lateral to the midline incision over the palpable hernia defect and the skin and subcutaneous tissue were sharply divided diwn to the level of the hernia sac, which was excised down to the level of the fascia, and the contents were then reduced in the abdominal cavity.¿ the (b)(6)2009 operative report continues: ¿the underlying fascia was then circumferentially cleared of overlying subcutaneous fat and underlying peritoneal adhesions for a distance of approximately 8 centimeters from the edge of 3 x 3-centimeter opening.This was then repaired with a large ventralex patch, which was placed intraabdominally and circumferentially attached with interrupted sutures of 2-0 prolene under direct visualization with good secure closure and the mesh laying flush against the peritoneum.After this was accomplished, the wound was terminally anesthetized using 0.5% marcaine with epinephrine.The subcutaneous tissue was reapproximated using 2-0 vicryl and the skin was closed using staples.¿ records dated (b)(6)2010 state: ¿the pt¿s wound is healing well and pt is complaining still of some left sided abdominal pain and irregular bowel movements with some fecal incontinence which is new for her.¿ ¿¿pt¿s wound is healing well and there is no evidence of any erythema, induration, cellulitis or drainage.¿ records dated (b)(6)2010 state: ¿pt¿s wound is healing well and is still complaining of left sided abdominal pain and now is complaining of increasing bowel movements with fecal incontinence along with some bleeding per rectum.¿ the records indicate the patient was scheduled to undergo a colonoscopy and was prescribed steroids for inflamed hemorrhoids.Records after 2010 indicate ongoing complaints of abdominal discomfort and pain.Records dated (b)(6)2013 state the patient underwent ¿diagnostic laparoscopy, extensive laparoscopic adhesiolysis, followed by open ventral wall incisional hernia and repair with mesh placed in the preperitoneal space.¿ postoperative diagnoses state: ¿1.Extensive intraabdominal adhesions.2.Ventral wall incisional hernias x5.¿ records dated (b)(6)2013 state the patient underwent ¿wound exploration, removal of infected mesh, extensive debridement of abdominal wall wound.¿ indications state: ¿a 56-year-old african-american female had ventral wall incisional hernias repaired about 6 weeks ago with polypropylene mesh.This became infected about a month later and she is brought in now for removal of the polypropylene mesh.¿ ¿findings: the mesh was densely adherent and incorporated into the abdominal wall wound.¿ records dated (b)(6) 2013 state: ¿¿i did a repair of a ventral wall hernia with mesh at the end of february of this year.That mesh became infected and i removed it on 04/08/2013 and since that time she has been on a vac dression.¿ records after 2013 indicate ongoing complaints of abdominal discomfort and pain.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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible 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.¿ 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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H6: corrected method/results codes - 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.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: operative records dated (b)(6)2010 indicate the patient underwent ¿excision of lower midline abdominal wall mass.¿ preoperative/postoperative diagnosis state: ¿lower abdominal incisional mass.¿ the records state: ¿the patient is a 54-year-old, black female with a long history of multiple a surgeries and a firm mass which was palpated in the lower portion of her midline incision enlarged and subsequently had persisted and was felt to represent either suture granuloma an incisional hernia.¿ operative records dated (b)(6)2010 state: ¿.A 6 cm elliptical incision was made, excising the old scar.There proved to be fibrofatty tissue level of the fascia, all of which was sharply excised in the lower midline of the abdomen.Of any hernias or suture granuloma was identified, the wound was ceref1.1lly explored, findi [sic] abnormalities.The subcutaneous tissue was reapproximated using 2-0 vicryl after being t [sic] anesthetized with 0.5% marcaine with epinephrine.The skin was closed using staples.¿ records after 2010 indicate ongoing complaints of abdominal discomfort and pain.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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible 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.¿ 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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H6: conclusion code remains unchanged.H10/11: corrected medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6)2001, including those detailing any previous abdominal surgical procedures, were not provided.Operative records dated (b)(6)2001 indicate the patient underwent attempted laparoscopic repair of an incisional hernia, followed by open repair.The records state: ¿the patient presented to my office with a bulge at the upper portion of a previous midline incision.It was obvious that she had an incisional hernia.¿ the (b)(6)2001 records state: ¿the fascia was incised and the muscle was pulled superiorly and inferiorly.The transverse abdominis muscle was then encountered and opened but i really could not find my way into the abdominal cavity.I drew up on a piece of tissue that i thought might be the peritoneum, although it seemed rather thick.I made a small, very shallow incision in it but it bled so i though[t] that it might, in fact, be bowel wall, so i closed the little nick with a 4-0 suture.Further exploration did not yield an obvious opening into the peritoneal cavity initially.Finally, we found our way into the peritoneal cavity and introduced the scope after insufflating the abdomen.We found that the omentum was adherent across the entire expanse of the abdomen and several loops of small bowel were stuck up under the omentum.Thus, we really could not see the anterior abdominal wall.I, therefore, decided that a laparoscopic approach to this particular hernia was not going to be possible and decided to fit it with open technique.¿ the (b)(6)2001 records continue: ¿an upper midline incision was then opened from the top of the incision which was about 2.5 inches above the umbilicus down to a little ways past the umbilicus.Dissection was carried down into the hernia sac.We dissected out the entire area and found three separate hernias.The largest one was in the midline and was about 3 cm long.There was one lying off to the right which was about 15 mm in size and one lying a little bit more inferiorly on the midline which was about 12 mm in diameter.I dissected the fast off the anterior fascia and dissected the adhesions of the omentum off the inside of the fascia and then placed a gore-tex mesh.This was a circular piece of mesh about 10 cm in diameter.Sutures were placed on the right and left and superiorly and inferiorly.The suture was brought through the fascia, through-and-through the mesh and then back up through the fascia.After these 4 sutures were placed, the knots were tied down, approximating the mesh to the back of the fascia of the abdomen.The defects themselves were then closed over the top of the mesh with the sutures incorporating a bit of the mesh.The midline incision was closed with vertical mattress suture of 3-0 nylon.The incision on the right side was closed at the fascia level with prolene and at the skin level with subcuticular 4-0 vicryl.¿ product identification records for the alleged ¿gore-tex mesh¿ were 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿possible 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.¿ 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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H6: additional conclusion codes: 4315: cause not established, 4316: appropriate code/term not available for "withdrawn complaint." previous patient code/codes (1695; 1994; 3191: other for ¿discomfort¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: ¿ the known medical records span (b)(6) 1991 through (b)(6) 2013 and not all records received in this time span are relevant to the unknown gore device and gore® dualmesh® biomaterial.¿ records between (b)(6) 1991 and (b)(6) 2001, including those detailing any previous abdominal surgical procedures, were not provided.Patient information: medical history: ¿ smoking.¿ chronic obstructive pulmonary disease [copd].¿ asthma.¿ obesity.¿ [history] of carcinoma of the uterus.¿ diabetes.¿ endometriosis.¿ irritable bowel syndrome with alternating bouts of constipation and diarrhea.¿ thyroid cancer.Prior surgical procedures: ¿ hysterectomy with oophorectomy.¿ partial resection of the small bowel.¿ colectomy.¿ hip surgery.¿ 2001: attempted laparoscopic repair of an incisional hernia, followed by open repair.¿ 2002: ¿repair with gore-tex dualmesh¿.¿ 2006: exploratory laparotomy, rectosigmoid resection, and lysis of extensive intraabdominal adhesions.¿ 2007: wound exploration and removal of infected hernia mesh.¿ 2008: recurrent incisional herniorrhaphy with mesh.¿ (b)(6) 2009: recurrent incisional herniorrhaphy with mesh.¿ (b)(6) 2009: recurrent incisional herniorrhaphy with mesh.¿ 2010: ¿two hernia repairs.¿ ¿ 2011: ¿hernia repair.¿ ¿ (b)(6) 2013: diagnostic laparoscopy, extensive laparoscopic adhesiolysis, followed by open ventral wall incisional hernia and repair with mesh placed in the preperitoneal space.¿ (b)(6) 2013: wound exploration, removal of infected mesh, extensive debridement of abdominal wall wound.Implant #1 preoperative complaints: ¿ (b)(6) 2001: ¿the patient presented to my office with a bulge at the upper portion of a previous midline incision.It was obvious that she had an incisional hernia.¿ implant #1 procedure: attempted laparoscopic repair of an incisional hernia, followed by open repair.[unknown ¿gore-tex mesh¿ ¿about 10 cm in diameter.¿].Implant #1 date: (b)(6) 2001 [hospitalization unknown].¿ description of hernia being treated: ¿the fascia was incised and the muscle was pulled superiorly and inferiorly.The transverse abdominis muscle was then encountered and opened but i really could not find my way into the abdominal cavity.I drew up on a piece of tissue that i thought might be the peritoneum, although it seemed rather thick.I made a small, very shallow incision in it but it bled so i though[t] that it might, in fact, be bowel wall, so i closed the little nick with a 4-0 suture.Further exploration did not yield an obvious opening into the peritoneal cavity initially.Finally, we found our way into the peritoneal cavity and introduced the scope after insufflating the abdomen.We found that the omentum was adherent across the entire expanse of the abdomen and several loops of small bowel were stuck up under the omentum.Thus, we really could not see the anterior abdominal wall.I, therefore, decided that a laparoscopic approach to this particular hernia was not going to be possible and decided to fit it with open technique.¿ ¿ implant size and fixation: ¿an upper midline incision was then opened from the top of the incision which was about 2.5 inches above the umbilicus down to a little ways past the umbilicus.Dissection was carried down into the hernia sac.We dissected out the entire area and found three separate hernias.The largest one was in the midline and was about 3 cm long.There was one lying off to the right which was about 15 mm in size and one lying a little bit more inferiorly on the midline which was about 12 mm in diameter.I dissected the fast [sic] off the anterior fascia and dissected the adhesions of the omentum off the inside of the fascia and then placed a gore-tex mesh.This was a circular piece of mesh about 10 cm in diameter.Sutures were placed on the right and left and superiorly and inferiorly.The suture was brought through the fascia, through-and-through the mesh and then back up through the fascia.After these 4 sutures were placed, the knots were tied down, approximating the mesh to the back of the fascia of the abdomen.The defects themselves were then closed over the top of the mesh with the sutures incorporating a bit of the mesh.The midline incision was closed with vertical mattress suture of 3-0 nylon.The incision on the right side was closed at the fascia level with prolene and at the skin level with subcuticular 4-0 vicryl.¿ ¿ product identification records for the alleged ¿gore-tex mesh¿ were not provided.¿ no post-operative records were provided.Implant #2 preoperative complaints: ¿ (b)(6) 2002: ¿mrs.(b)(6) has had procedures to the midline to treat endometriosis and bowel obstructions.She developed an incisional hernia, which i first dealt with a year ago.She then returned to see me with an uncomfortable bulge above the area where the previous operation had been done.I thought i placed a mesh at the top of the incision, but obviously the incision came up a little higher, and she had an incisional hernia at the top of the old incision.I suggested repair.¿ implant #2 procedure: ¿repair with gore-tex dualmesh.¿ implant #2 date: (b)(6) 2002.¿ description of hernia being treated: ¿the patient was placed in a supine position, and general anesthesia was induced.The abdomen was prepped and draped in the usual fashion.An incision was made extending over the top 1" of old incision, and then above onto previously unincised abdominal skin for another 1".¿ implant size and fixation: ¿dissection was carried down on to a very sharply circumscribed midline fascial defect which was about 12 mm in diameter.On dissecting beneath the fascia, i found the upper edge of the gore-tex just a few millimeters inferior to the area of the present hernia.The overlying subcutaneous fat was dissected away, and i then placed another piece of gore-tex to repair this defect.0 prolene was used, the stitch was taken through the fascia, through and through the gore-tex, and then back up to the fascia.The piece of gore-tex was cut in an octagonal shape and was longer from right to left than from top to bottom.From right to left, it was about 6 cm, and from top to bottom it was about 4.0 to 4.0 cm [sic].Stitches were placed circumferentially at the top, bottom, right and left.¿ ¿after all sutures were placed, the mesh was pulled up against the back of the abdominal wall.The lower stitch went through the old piece of gore-tex and then through the new piece.We made sure that the gore-tex was lying against the back of the abdominal wall, and that the corrugated side of the mesh was up against the back of the abdominal wall.After trying [sic] down all of these prolene sutures, the defect itself was approximated with figure-of-eight suture of 0 prolene which incorporated the underlying gore-tex in the stitch.Skin was closed with continuous vertical mattress 3-0 nylon.¿ ¿ product identification records for the alleged ¿gore-tex dualmesh¿ device were not provided.¿ there is no mention of infection and no mention of gore device removal.¿ no post-operative records were provided.Relevant medical information: ¿ (b)(6) 2004: ¿.Complaints of mid abdominal pain with bouts of diarrhea.The pt [patient] notes that this has been persistent for three months¿¿ ¿ (b)(6) 2004: ¿pt is s/p [status post] colonoscopy which failed to demonstrate any abnormalities.The pt still complains of some crampy abd [abdominal] pain and multiple bowel movements with uncertain etiology at this point.¿ ¿the pt had similar symptoms which dated back to 1991 by ct scan at tci.¿ ¿ (b)(6) 2004: ct abdomen: ¿evidence of abdominal hernia repair along the ventral abdominal wall is seen.There is clip in the left adnexal region related to prior surgery.Impression: no definite acute intra-abdominal process.Postsurgical changes as above.¿ [there was no mention of the mesh in the records.] ¿ (b)(6) 2006: ¿pt is sp be [barium enema] which demonstrated sigmoid and descending diverticular disease.The pt continues to have pain on her left side of her abdomen and lower abd which is likely secondary to the same.It is recommended to the pt that she have a low anterior resection¿¿ ¿ (b)(6) 2006: exploratory laparotomy, rectosigmoid resection, and lysis of extensive intraabdominal adhesions.Postoperative diagnoses: ¿lower abdominal pain.Diverticulosis.Extensive intraabdominal adhesions.¿ ? ¿the skin and subcutaneous tissue were sharply undermined, along with the fascia and the patient's incisional hernia or mesh, which was incised longitudinally and the abdominal cavity was then entered and the patient was found to have extensive intraabdominal adhesions and the next two hours of the operation, greater than 80% of the operating time was then devoted to lysing adhesions, which were densely adherent to the patient's pelvis, between the small bowel, the omentum, loops of small bowel to the rectosigmoid colon.The splenic flexure was then widely mobilized under direct visualization in order to gain length into the pelvis and the lateral colonic attachments divided along the pericolic gutter using electrocautery and sharp and blunt dissection, electrocautery for hemostasis until the rectosigmoid colon was loosened from its distorted, twisted state in the left side of the pelvis.¿ ¿this was freed up and ureters were easily identified and the descending colon was then divided using gia-stapler and the mesocolon was then divided serially using a ligasure device, down to the mid rectum, where the rectum was divided using gia-stapler and a side to side functional anastomosis was then created using the gia-stapler and coloproctostomy was then sewn in two layers using a running 4-0 prolene suture and a running lembert fashion suture and the anastomosis was seen to lay easily, without tension in the left lower pelvis and the abdomen was then thoroughly irrigated and aspirated.A blake drain was brought in through the left lower quadrant through a separate stab wound, placed in the pelvis.A sheet of seprafilm was placed in the pelvis and the omentum was widely mobilized and the omentum was then laid, replaced in the abdominal cavity and a piece of seprafilm was then placed on top of the omentum, under the incision, which was then closed using a running suture of #1 prolene.Skin was closed using staples.¿ ? there is no mention of infection and no mention of gore device removal.? there are no post-operative records.¿ (b)(6) 2006: ¿pt is sp left colectomy and pt has a wound infection which looks markedly improved today and the superior opening has completely closed.Inferiorally the pt¿s wound has a 1x1x2 cm opening inferiorally [sic] and at this point the pt still has some sero purulent drainage from this¿¿ ¿ (b)(6) 2006: ¿pt returns today for evaluation of ongoing complaints of abdominal pain and pt¿s lower midline wound is nearly completely healed and pt has good granulation tissue which is cauterized.¿ ¿ (b)(6) 2006: ¿pt is returns [sic] today for wound evaluation and pt has ongoing difficulty with persistent drainage from two areas which have drained before.The superior one skin closed and this is probed again and drained of serosanguineous fluid and there is no evidence of erythema, induration or cellulitis.At this point the pt is to be started on bactrim ds¿.And should this fail to resolve some of this infection and drainage than [sic] pt may require wound exploration¿.¿ explant preoperative complaints: ¿ (b)(6) 2006: ¿pt is seen today in f/u [follow up] for evaluation of persistent wound drainage just above and just inferior to the level of the umbilicus.Both wounds are probed and pt continues to have drainage from the incision.Plan at this time is for wound exploration as pt behaves as she has a wound seroma and or granuloma which refuses to resolve.¿ explant procedure: wound exploration and removal of infected hernia mesh.Explant date: (b)(6) 2007 [hospitalization unknown].¿ ¿¿status post left colectomy with incisional subsequent herniorrhaphy with mesh with persistent wound drainage from the mid portion of her incision undergoing wound exploration.¿ ¿the skin and subcutaneous tissue were sharply entered down to the level of the fascia on top of this where the patient was noted to have an infected mesh which was circumferentially removed in its entirety and along with several loose #1 prolene sutures.After this was accomplished, granulation tissue was cauterized and removed.The wound was packed open, and the wound was terminally anesthetized using 0.5% marcaine, packed open with dry gauze.¿ relevant medical information: ¿ (b)(6) 2007: ¿pt is sp removal of infected ventral hernia mesh.Pt has a superior upper midline right sided incisional hernia as well which continues to persist and is moderately symptomatic but reducible.Pt is moving her bowels and eating without difficulty.Pt at this point still complains of abdominal wall pain but her wound measures approximately 6 cm in length and 3.5 cm in width and is pink granulating in nicely.There is no evidence of any erythema, induration or cellulitis.¿ ¿ (b)(6) 2007: ¿pt is seen today in f/u after removal of her infected mesh.Her wound inferiorally [sic] has healed nicely and superiorally [sic] the pt has drainage from a second subcutaneous abscess and has some pink granulation tissue.Plan at this point is for exploratory laparotomy and scar removal and repair of incisional hernia with collamend mesh under general.¿ ¿ (b)(6) 2007: recurrent incisional herniorrhaphy.¿the patient is 50 -year-old obese black female that smokes who noted to have status post left colectomy having had previous incisional herniorrhaphy with mesh now with recurrence of same status post excision of infected mesh for repair and re-closure of ventral hernia.¿ ¿¿.A collamend mesh which measured 6 x 8 inches was then brought in after being soaked in saline for several minutes ahead of time, was brought into the incision and trimmed to appropriate size in an oval fashion, circumferentially attached to the fascia with interrupted sutures of #1 prolene, and placed through the fascia in a circumferential fashion under direct visualization.The mesh was then finally trimmed to appropriate size and redundant mesh was removed.Several interrupted sutures of fascia were placed to bring the somewhat redundant fascia across the top of the repair loosely, and a 7 mm blake drain was brought in through a separate right lower quadrant stab wound.The subcutaneous tissue was then reapproximated using running 2-0 vicryl suture, and the skin was closed using staples.¿ ¿ (b)(6) 2007: ¿pt is having a great deal of serous drainage from the lower portion of her incision which started this morning and the wound is probed and the pt has some mild inflammatory changes of the subcutaneous tissue surrounding this¿¿ ¿ (b)(6) 2007: ¿pt is sp i&d [incision and drainage] and re-opening of her midline wound from her an [sic] incisional herniorrhaphy with bioprosthetic mesh.The wound has minimal drainage at this time and is re-propped [sic] with a q-tip.¿ ¿ (b)(6) 2007: ¿¿.Complaints of ruq right superior para incisional pain and mass.The pt did have a separate hernia repair at the time of her previous incisional herniorrhaphy with mesh and pt has had a recent ct scan of the abdomen and pelvis which failed to demonstrate any repeat abdominal wall mass, abscess or hernia or abnormality apart from midline scar tissue which is to be expected.¿ ¿ (b)(6) 2007: ¿there is no evidence of any infection, abscess, recurrent incisional herniation or foreign body in her anterior abdominal wall.The pt¿s wound and interior abdominal wall exam are otherwise unchanged.Pt is complaining of patch like hipesthesias [sic] in the right upper superior portion of her midline wound just lateral to the incision on the right side which shows no evidence of any cellulitis, erythema or induration or recurrent hernia.At this point the pt notes that she had a local topical skin reaction to the lidoderm patches¿¿ ¿ (b)(6) 2008: recurrent incisional herniorrhaphy with mesh.¿ (b)(6) 2009: recurrent incisional herniorrhaphy with mesh.¿ (b)(6) 2009: recurrent incisional herniorrhaphy with mesh.¿ (b)(6) 2010: ¿excision of lower midline abdominal wall mass.¿ ¿ (b)(6) 2013: ¿diagnostic laparoscopy, extensive laparoscopic adhesiolysis, followed by open ventral wall incisional hernia and repair with mesh placed in the preperitoneal space.¿ ¿ (b)(6) 2013: ¿wound exploration, removal of infected mesh, extensive debridement of abdominal wall wound.¿ conclusion: the alleged ¿gore-tex¿ mesh is being captured as gore-tex® soft tissue patch for product surveillance purposes.It should be noted that the gore-tex® soft tissue patch 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-tex® soft tissue patch is provided sterile.Procedure and specific patient factors may contribute to or cause infection, leading to contamination or infection of the mesh material.The instructions for use further 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.¿ the gore-tex® soft tissue patch ifu also states, ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.Do not contaminate or damage the patch.¿ 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 wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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.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 above inherent risks are typically detailed in standard informed consent documents.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.Based upon the information received, status of the device is unable to be confirmed and therefore not available for evaluation.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.Although a review of manufacturing and sterilization records could not be performed, all pre-release specifications are confirmed prior to release as part of quality system processes.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.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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Search Alerts/Recalls
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