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| Device Problems
Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 07/09/2008 |
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Event Type
Injury
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Manufacturer Narrative
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Other relevant history: added medical history.(b)(4).Added medical record information.(b)(6).Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records (provided below) indicate an alleged gore® dualmesh® biomaterial was implanted in (b)(6) 2007 and explanted during the (b)(6) 2008 procedure.Records prior to (b)(6) 2008, including records for cesarean sections x3, cholecystectomy, repair of fascia (2007), and previous hernia repairs (2003, 2004, 2006, 2007), were not provided.Furthermore, implant and product identification records for a gore® dualmesh® biomaterial allegedly implanted in (b)(6) 2007, as noted in the (b)(6) 2008 records, were not provided.Pathology report dated (b)(6) 2008 for specimen collected (b)(6) 2008 states: ¿final pathologic diagnosis: second portion duodenum biopsy: congestion, focal erosion and mild chronic nonspecific inflammation.No evidence of h.Pylori.Gastric antrum biopsy: mild nonspecific chronic inflammation.No evidence of h.Pylori.Gross description: the specimen is received in 2 parts: consists of 1 piece of golden tissue measuring 0.2 cm in greatest dimension.Submitted in toto in one block.Consists of 1 piece of pale tan tissue measuring 0.2 x0.1 x.0.1 cm.Submitted in toto in one block.¿ operative records dated (b)(6) 2008 indicate the patient underwent reduction and repair with mesh implant for acute incarcerated incisional hernia with lysis of extensive adhesions.Preoperative/postoperative diagnosis ¿acute recurrent incisional hernia with partial incarceration of colon and small bowel loops, mild acute sma syndrome with adhesions.¿ operative records dated (b)(6) 2008 state: ¿indications/findings the patient had multiple abdominal surgeries including three c-sections, bilateral tubal ligation, repair of recurrent incisional hernias and cholecystectomy by laparoscopy, etc.About two months prior to admission at this time as the patient stated she was involved in a fight from which she fell on her lower back sustaining persistent progressive mid abdominal pain ever since.She was admitted on (b)(6) 2008 through the emergency room because of unbearable acute abdominal pain and a ct scan of the abdomen and pelvis revealed recurrent incisional hernia containing colon and small bowel loops without obstruction, therefore, the incarceration was partial.¿ operative records dated (b)(6) 2008 continue: ¿meanwhile, a question of acute superior mesenteric artery syndrome was raised on the ct scan although there was no obstruction and the angle was not sharp enough to qualify [sic] for a syndrome.The patient was admitted for management and gi consultation was obtained.On (b)(6) it was determined to undergo the reduction and repair of the incarcerated incisional hernia along with lysis of the extensive adhesions.¿ operative records dated (b)(6) 2008 continue: ¿during surgery there was significant recurrent incisional hernia by 2 inches in size on the left side of the mid abdomen with significant weakness of the incisional hernia that contained part of the colon and small bowel.Nevertheless, there was extensive peritoneal adhesions with greater omentum of the transverse colon as well as some of the small bowel loops.This was the presumptive cause for the ct findings to raise question of mild degree of superior mesenteric artery syndrome.¿ operative records dated (b)(6) 2008 state: ¿transverse incision was made in the low epigastric region along with the existing scar.The incision was lengthened down to the fascial plane and the weakness from her hernia was noted along with separate hernia development through the left side of the previous scar.This small hernia is about 1.5 inches in size.The hernia sac was then incised in a transverse fashion and the peritoneum was carefully incised and the underlying adherent omentum and bowel loops were carefully and completely released from the undersurface of the surrounding peritoneal lining.¿ operative records dated (b)(6) 2008 state: ¿the hernia defect on the left side of the scar area was dearly defined by releasing the surrounding soft tissue so as to delineate the fascial plane of this hernia defect which was then closed with multiple interrupted sutures of #1 , non-absorbable ethibond sutures.Again, the undersurface of the entire hernia defect was prepared and dual mesh was chosen, tailored, and placed underneath the hernia defect with a smooth surface facing the abdominal cavity.The repair was achieved with placement of multiple interrupted sutures of #1 ethibond sutures which carried through the full-thickness of the abdominal wall and catching the dualmesh.¿ operative records dated (b)(6) 2008 state: ¿this suture technique with #1 ethibond sutures was repeated way around the hernia defect and then the sutures were tied properly so as to achieve the repair with mesh without undue tension.The fascia edges were also reapproximated with multiple interrupted sutures of #0 ethibond sutures.The wound was irrigated with sterile saline solution, hemostasis was complete.The wound was then closed with interrupted sutures of 2-0 and 3-0 vicryl sutures for the fascia and subcutaneous and staples for the skin.Sterile dressing was applied." product identification records for the gore® dualmesh® biomaterial were not provided.Operative report dated (b)(6) 2008 indicates the patient underwent incision and drainage, deep debridement with removal of infected meshes, placement of vac suction apparatus.Preoperative/postoperative diagnosis ¿abdominal wound infection with meshes, status post reduction and repair with mesh for recurrent incisional hernia.¿ operative records dated (b)(6) 2008 state: ¿indications: the patient had previously had multiple abdominal procedures including cesarean section, laparoscopic cholecystectomy; repair of hernias multiple times with recent repair with mesh and lysis of adhesions for superior mesenteric artery syndrome.Two weeks after the procedure, the wound got infected and a culture showed (b)(6) for which she was placed on antibiotics for which it was sensitivity-guided.The infection gradually improved yet persistent.Therefore, the patient was admitted for surgical intervention at this time.¿ operative records dated (b)(6) 2008 state: ¿a small penrose was removed and the wound was opened in transverse fashion about one inch above the umbilicus.The incision was deepened and the necrotic tissues were removed and the wound was thoroughly irrigated with sterile saline solution.Numerous ethibond suture were then removed and a pocket of abscess was noted approximately one inch in diameter which was irrigated after the culture was taken and then the infected mesh was noted which was then removed after the fascial plane was incised and all of the visible sutures removed.¿ operative records dated (b)(6) 2008 state: ¿the two meshes were removed from the subfascial plane and the peritoneum was not entered.Again, the abscess cavity was irrigated after thorough debridement.Hemostasis was made complete and sterile gauze was then placed after the fascia was partially closed with 0 vicryl.A jp tube was placed on top of the gauze which was again covered with multiple sterile gauze and the entire wound and dressing were covered securely with tegaderm so as to create vacuum assisted closure while the jp tube was connected to suction apparatus.¿ pathology report dated (b)(6) 2008 for specimen collected (b)(6) 2008 states: ¿specimen a.Mesh.Gross description: the specimen is received in one part, in formalin, labeled "mesh", and it consists of a portion of white, synthetic tissue, measuring 6.5 x 5.3 cm.No sections.Microscopic description: no sections submitted.History and physical dated (b)(6) 2008 states: ¿this patient was previously seen by me for evaluation of multiple recurrent incisional hernia.She returns today for her preoperative history and physical.The records state: ¿this is a woman with multiple recurrent incisional hernias which desires repair.Given the complexity of the orientation of the scars, i believe the optimal treatment is an excision of the transverse scar and the midline, down to the fascia defects.We need to be certain that she does not have any retained previously infected mesh with (b)(6) or ethibond sutures.All this must be removed at the time of surgery.Then she probably will need a component separation technique to bring the fascia in the midline and this should be buttress with a biologic tissue graft because of the 50% risk of infection of the permanent prosthesis given the previous (b)(6) infection.¿ operative records dated (b)(6) 2008 indicate the patient underwent excision of scar tissue, skin, fat, fascia, and muscle , repair of multiple recurrent incisional hernias with a porcine heterograft (16 x 28 cm) and bilateral myofascial advancement flaps.Preoperative/postoperative diagnosis ¿multiple recurrent, incarcerated incisional hernia, previous (b)(6) infection of the abdominal wall.¿ operative records dated (b)(6) 2018 state: ¿the patient is a (b)(6) african american woman who has had multiple previous abdominal operations, in fact greater than 8 for recurrent incisional hernias.Most recently she had removal of infected mesh, which was due to (b)(6).The wound was closed primarily and she developed a recurrent hernia.She has had most of her hernias done through a transverse upper midline incision, and has also had lower midline hernias.On this basis, she was offered an abdominal wall reconstruction to repair all hernias in the abdomen, excise potentially infected previous scar tissue and the sutures.¿ operative records dated (b)(6) 2008 state: ¿findings: the primary fascial incisional hernia which was in the central midabdomen measured approximately 10 x 10 cm.Superior and inferior to this, the fascia was quite tenuous and fenestrated with other incisional hernias.After all this was excised, the abdominal fascial defect measured 20 cm in length.The fascial space between the right and the left rectus measured approximately 12 cm.There was no intra-abdominal pathology.The uterus was normal to palpation as were both adnexa.There were no masses in the liver.There were no extensive adhesions within the abdominal cavity.There was incarcerated omentum circumferentially in the hernia sac.The patient's anterior abdominal wall rectus muscles were fairly robust and she had well-developed lateral fascia.¿ operative records dated (b)(6) 2008 state: ¿an incision from the xiphoid down to the pubis was made.This circumferentially excised all the previous scar tissue, attenuated fascia and muscle, and subcutaneous tissue.In addition, there were numerous previously-placed tycron sutures throughout the wound with some edema around them consistent with a chronic indolent (b)(6) infection.Hemostasis was achieved following excision of all this material which weighed approximately 340 g.Because of the size of the fascial defect, bilateral rectus advancement flaps, using a component separation technique, was performed.¿ operative records dated (b)(6) 2008 continue: ¿this was done by creating a subcutaneous tunnel lateral to the midline out approximately 2 cm lateral to the edge of the rectus.The external oblique contribution to the anterior rectus sheath was incised.The incision was extended cephalad and caudad with the metzenbaum scissors.Then the external oblique was separated from the components of the internal oblique deep to it, to allow the rectus to slide medially.This was done bilaterally and we were able to approximate the rectus in the midline with undue tension.¿ operative records dated (b)(6) 2008 state: ¿we then took a piece of porcine stratus heterograft 20 x 20 cm.This was turned in a triangular fashion to give us 28 cm in length and then 5 cm were cut off each side to create a heterograft measuring 28 cm in length by 16 cm in width.Preplaced 0 prolene horizontal mattress sutures were placed transversely on the lateral aspects of this mesh and then it was inserted in the intra- abdominal position.#1 prolene sutures were used to secure the mesh circumferentially with at least an 8 cm underlay in all directions.Each suture was placed and then tied sequentially in order to avoid any wrinkles in the mesh, and in order to distribute the tension circumferentially.¿ operative records dated (b)(6) 2008 state: ¿counterincisions were made far lateral on the abdominal wall on the right and the left sides and the suture passer was used to pull through the previous placed horizontal mattress sutures.These were then tied sequentially as discussed above.Cephalad, again, interrupted horizontal mattress sutures were placed, and it should be noted that the falciform ligament was taken down off the anterior abdominal wall and the mesh extended up above the liver.All the spaces in between these horizontal mattress sutures were closed using interrupted 3-0 vicryl suture sewed to the posterior rectus sheath.¿ operative records dated (b)(6) 2008 state: ¿a sponge count was taken at that time and confirmed to be correct.Two #10 jackson-pratt drains were placed anterior to the mesh, brought out through the midline fascia closure.The fascia was then closed using far-far, near-near interrupted 0 prolene sutures.This was after all the redundant poor scarred rectus fascia and muscle was excised.In so doing, the fascia was able to be brought together without undue tension in the midline.Then a #10 jackson-pratt drain was placed into the subcutaneous pocket used to create the component separation both on the right and left side and these were brought out through separate stab wound incisions on the anterior abdominal wall.¿ operative records dated (b)(6) 2008 state: ¿hemostasis was then achieved.The wound was irrigated and then the midline wound was approximated using deep dermal interrupted 3-0 vicryl sutures.The skin was closed with a running subcuticular absorbable suture.Steri-strips were placed.The drains were all secured with 2-0 nylon suture.0.25% marcaine was used to infiltrate all of the counterincisions.These were closed with subcuticular absorbable sutures.Sterile dressing was applied to all the incision sites.¿ records confirm a strattice (non gore device) was used during the procedure.Pathology report dated (b)(6) 2008 for a specimen (abdominal scar tissue with fascia) collected (b)(6) "2015" states: ¿gross description: received fresh with the container labelled with the patient's name and requisition labelled "abdominal scar tissue with fascia" is an elliptical smooth tan pink portion of skin 35 x 7 cm.Excised to a depth of 2 cm.Centrally the skin is umbilicated, umbilicus with a t shaped well healed scar present 19 x 7 cm.Subcutaneous tissue is homogeneous and yellow with deep margin showing smooth white foci consistent with fibrous tissue.Random transmural sections of skin and scar are submitted with deep margin inked.Diagnosis: skin and subcutaneous tissue, abdominal, excision fibrosis.¿ discharge summary dated (b)(6) 2008 indicates patients was admitted to the hospital on (b)(6) 2008 for recurrent incisional hernia.The records state: ¿past surgical history: she has had a c-section x3, the last one in 2003.In 2003 and 2004, the patient had her first incisional hernia repair with mesh.On (b)(6) 2006, she underwent another repair of recurrent incisional hernia with dr.(b)(6).In (b)(6) 2007, the patient underwent a repair of fascia which was plicated.In (b)(6) 2007, open incisional hernia repair with dual mesh.In (b)(6) 2008, the patient underwent a repeat incisional hernia repair with dual mesh.In (b)(6) 2008, incision and drainage of infected wound, (b)(6) for (b)(6).Removal of two pieces of mesh and wound vac was placed.¿ records between (b)(6) 2008 and (b)(6) 2010 were not provided.Operative records dated (b)(6) 2010 indicate the patient underwent omentectomy, reduction and repair of acute incisional hernia with omentum incarceration.Preoperative/postoperative diagnosis ¿acute incarcerated incisional hernia.¿ the records state: ¿the patient has had multiple abdominal surgeries in the past, including 3 c-sections, cholecystectomy, and repair of incisional hernia multiple times, including implantation of a large biological graft of the abdominal wall.At this time, the hernia had recurred, involving the distal portion of the midline scar.The hernia sac was 1.5 inches in diameter, containing greater omentum which was incarcerated.There is no mention of a gore device in the records.Records between (b)(6) 2010 and (b)(6) 2012 were not provided.Operative records dated (b)(6) 2012 indicate the patient underwent laparoscopic repair, recurrent incisional hernia with mesh.Preoperative/postoperative diagnosis ¿recurrent incisional hernias.¿ the records indicate a ventralex st mesh was used during the procedure.There is no mention of a gore device.Records between (b)(6) 2012 and (b)(6) 2016 were not provided.Operative records dated (b)(6) 2016 indicate the patient underwent repair of incarcerated recurrent incisional hernia.Preoperative/postoperative diagnosis ¿incarcerated recurrent incisional hernia.¿ findings: 1.Small bowel loop within the hernia which was hemorrhagic, however, not ischemic.2.The bowel regained color with time.3.The herniation was through the previous undersurface of the mesh.4.Any exposed mesh was excised.5.Hemostasis obtained.¿ there is no mention of a gore device in the records.Operative records dated (b)(6) 2017 indicate the patient underwent exploratory laparotomy, lysis of adhesions, primary repair of incisional hernia.Preoperative/postoperative diagnosis ¿closed loop small bowel obstruction secondary to incarcerated incisional hernia.¿ the records state: ¿the patient is a (b)(6) woman who has a history of 15 prior abdominal surgeries.About 1-1/2 year ago, she had undergone an exploratory laparotomy and primary repair with incarcerated incisional hernia for a bowel obstruction secondary to incisional hernia at that time, the hernia was repaired primarily.She had been complaining of recurrent hernia and was planning on definitive repair of extensive midline defect; however, she presented to the emergency department with a bowel obstruction prior to being able to perform elective repair.¿ there is no mention of a gore device in the records.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® 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.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® 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) 2008, whereby an alleged gore device was implanted.The complaint alleges that on (b)(6) 2008, an additional procedure occurred whereby the device was explanted.It was reported the patient alleges the following injuries: infection of mesh, drainage, debridement, removal of mesh, additional surgery.Additional event specific information was not provided.
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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: 12/01/14: [missing records: records for emergency room visit for abdominal pain other specified site.] 12/29/14: [missing records: (b)(6) regarding unsymmetrical ventral hernia without obstruction/gangrene were not provided.] 02/06/15: [missing records: records for ambulance service via transcare regarding abdominal pain, unspecified site were not provided.Records for observation admission were not provided.] 10/10/15: [missing records: records from (b)(6) regarding ventral hernia without obstruction/gangrene were not provided.] 10/20/15: [missing records: records from (b)(6) regarding incisional hernia without obstruction/gangrene were not provided.] 07/04/16: [missing records: records from ct abdomen/pelvis were not provided.] 09/18/17: [missing records: records for emergency room visit at lawrence hospital were not provided.Records for ct abdomen/pelvis were not provided.] 08/18/18: [missing records: records for ct abdomen/pelvis were not provided.] 08/20/18: [missing records: records from (b)(6) regarding incisional hernia without obstruction/gangrene were not provided.] 08/23/18: [missing records: records for incisional hernia repair without obstruction/gangrene done on 08/23/18 were not provided.Records for pathology reports for specimens collected during operation on 08/23/18 were not provided.] 08/27/18: [missing records: records for abdominal x-ray were not provided.] 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® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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: health effect impact code: f1903.H6: conclusion code 4316: appropriate term/code not available for ¿withdrawn complaint¿.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span june 3, 2008 through december 5, 2017, and not all records received in this time span are relevant to the two gore® dualmesh® biomaterial implants.Records prior to june 3, 2008, including records for cesarean sections x3, cholecystectomy, repair of fascia (2007), and previous hernia repairs (2003, 2004, 2006, 2007) were not provided.Patient information: medical history: history of asthma.(b)(6) 2008: acute recurrent incisional hernia.Prior surgical procedures: (b)(6) 2003: history of cesarean section x3.History of multiple recurrent incisional hernia repairs 2003, 2004, 2006, 2007.(b)(6) 2007: repair of fascia, cholecystectomy, bilateral tubal ligation.Implant preoperative complaints: pathology report dated 06/03/08 for specimen collected (b)(6) 2008 [unknown procedure]: ¿a.Second portion duodenum biopsy: congestion, focal erosion and mild chronic nonspecific inflammation.B.Gastric antrum biopsy: mild nonspecific chronic inflammation.¿ (b)(6) 2008: preoperative/postoperative diagnosis ¿acute recurrent incisional hernia with partial incarceration of colon and small bowel loops, mild acute sma syndrome with adhesions.¿ (b)(6) 2008: ¿the patient had multiple abdominal surgeries including three c-sections, bilateral tubal ligation, repair of recurrent incisional hernias and cholecystectomy by laparoscopy, etc.About two months prior to admission at this time as the patient stated she was involved in a fight from which she fell on her lower back sustaining persistent progressive mid abdominal pain ever since.She was admitted on (b)(6) 2008 through the emergency room because of unbearable acute abdominal pain and a ct scan of the abdomen and pelvis revealed recurrent incisional hernia containing colon and small bowel loops without obstruction, therefore, the incarceration was partial.¿ (b)(6) 2008: ¿meanwhile, a question of acute superior mesenteric artery syndrome was raised on the ct scan although there was no obstruction and the angle was not sharp enough to cualify [sic, qualify] for a syndrome.The patient was admitted for management and gi consultation was obtained.On june 4th it was determined to undergo the reduction and repair of the incarcerated incisional hernia along with lysis of the extensive adhesions.¿ implant procedure: reduction and repair with mesh implant for acute incarcerated incisional hernia with lysis of extensive adhesions.Implants: 2- gore® dualmesh® biomaterial [product identification records were not provided] implant date: (b)(6) 2008.Description of hernia being treated: ¿during surgery there was significant recurrent incisional hernia by 2 inches in size on the left side of the mid abdomen with significant weakness of the incisional hernia that contained part of the colon and small bowel.Nevertheless, there was extensive peritoneal adhesions with greater omentum of the transverse colon as well as some of the small bowel loops.This was the presumptive cause for the ct findings to raise question of mild degree of superior mesenteric artery syndrome.¿ ¿transverse incision was made in the low epigastric region along with the existing scar.The incision was lengthened down to the fascial plane and the weakness from her hernia was noted along with separate hernia development through the left side of the previous scar.This small hernia is about 1.5 inches in size.The hernia sac was then incised in a transverse fashion and the peritoneum was carefully incised and the underlying adherent omentum and bowel loops were carefully and completely released from the undersurface of the surrounding peritoneal lining.¿ implant size and fixation: ¿the hernia defect on the left side of the scar area was clearly defined by releasing the surrounding soft tissue so as to delineate the fascial plane of this hernia defect which was then closed with multiple interrupted sutures of #1, non-absorbable ethibond sutures.Again, the undersurface of the entire hernia defect was prepared and dual mesh was chosen, tailored, and placed underneath the hernia defect with a smooth surface facing the abdominal cavity.The repair was achieved with placement of multiple interrupted sutures of #1 ethibond sutures which carried through the full -thickness of the abdominal wall and catching the dualmesh.¿ ¿this suture technique with #1 ethibond sutures was repeated way around the hernia defect and then the sutures were tied properly so as to achieve the repair with mesh without undue tension.The fascia edges were also reapproximated with multiple interrupted sutures of #0 ethibond sutures.The wound was irrigated with sterile saline solution, hemostasis was complete.The wound was then closed with interrupted sutures of 2-0 and 3-0 vicryl sutures for the fascia and subcutaneous and staples for the skin.Sterile dressing was applied¿ no postoperative records.Explant preoperative complaints: (b)(6) 2008: ¿indications: the patient had previously had multiple abdominal procedures including cesarean section, laparoscopic cholecystectomy; repair of hernias multiple times with recent repair with mesh and lysis of adhesions for superior mesenteric artery syndrome.Two weeks after the procedure, the wound got infected and a culture showed mrsa for which she was placed on antibiotics for which it was sensitivity-guided.The infection gradually improved yet persistent.Therefore, the patient was admitted for surgical intervention at this time.¿ explant procedure: incision and drainage, deep debridement with removal of infected meshes, placement of vac suction apparatus.Explant date: (b)(6) 2008.¿a small penrose was removed and the wound was opened in transverse fashion about one inch above the umbilicus.The incision was deepened and the necrotic tissues were removed and the wound was thoroughly irrigated with sterile saline solution.Numerous ethibond suture were then removed and a pocket of abscess was noted approximately one inch in diameter which was irrigated after the culture was taken and then the infected mesh was noted which was then removed after the fascial plane was incised and all of the visible sutures removed.¿ ¿the two meshes were removed from the subfascial plane and the peritoneum was not entered.Again, the abscess cavity was irrigated after thorough debridement.Hemostasis was made complete and sterile gauze was then placed after the fascia was partially closed with 0 vicryl.A jp tube was placed on top of the gauze which was again covered with multiple sterile gauze and the entire wound and dressing were covered securely with tegaderm so as to create vacuum assisted closure while the jp tube was connected to suction apparatus.¿ relevant medical information: culture reports for specimens collected during the (b)(6) 2008 procedure were not provided.(b)(6) 2008: pathology report for specimen collected (b)(6) 2008: ¿specimen a.Mesh.The specimen.Labeled ¿mesh¿, and it consists of a portion of white, synthetic tissue, measuring 6.5 x 5.3 cm" conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warns : ¿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 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.¿ 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.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.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.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: updated health effect- clinical code.H6: updated investigation findings.H6: updated investigation conclusions.H6: health effect impact code: h6: conclusion code 4316: appropriate term/code not available for ¿withdrawn complaint.¿ the investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records june 3, 2008 through december 5, 2017, and not all records received in this time span are relevant to the two gore® dualmesh® biomaterial implants.Records prior to june 3, 2008, including records for cesarean sections x3, cholecystectomy, repair of fascia (2007), and previous hernia repairs (2003, 2004, 2006, 2007) were not provided.Patient information: medical history: history of asthma.(b)(6) 2008: acute recurrent incisional hernia.Prior surgical procedures: (b)(6) 2003: history of cesarean section x3.History of multiple recurrent incisional hernia repairs 2003, 2004, 2006, 2007.(b)(6) 2007: repair of fascia, cholecystectomy, bilateral tubal ligation.Implant preoperative complaints: pathology report dated (b)(6) 2008 for specimen collected (b)(6) 2008 [unknown procedure]: ¿a.Second portion duodenum biopsy: congestion, focal erosion and mild chronic nonspecific inflammation.B.Gastric antrum biopsy: mild nonspecific chronic inflammation.¿ (b)(6) 2008: preoperative/postoperative diagnosis ¿acute recurrent incisional hernia with partial incarceration of colon and small bowel loops, mild acute sma syndrome with adhesions.¿ (b)(6) 2008: ¿the patient had multiple abdominal surgeries including three c-sections, bilateral tubal ligation, repair of recurrent incisional hernias and cholecystectomy by laparoscopy, etc.About two months prior to admission at this time as the patient stated she was involved in a fight from which she fell on her lower back sustaining persistent progressive mid abdominal pain ever since.She was admitted on (b)(6) 2008 through the emergency room because of unbearable acute abdominal pain and a ct scan of the abdomen and pelvis revealed recurrent incisional hernia containing colon and small bowel loops without obstruction, therefore, the incarceration was partial.¿ (b)(6) 2008: ¿meanwhile, a question of acute superior mesenteric artery syndrome was raised on the ct scan although there was no obstruction and the angle was not sharp enough to qualify [sic, qualify] for a syndrome.The patient was admitted for management and gi consultation was obtained.On (b)(6) it was determined to undergo the reduction and repair of the incarcerated incisional hernia along with lysis of the extensive adhesions.¿ implant procedure: reduction and repair with mesh implant for acute incarcerated incisional hernia with lysis of extensive adhesions.Implants: 2- gore® dualmesh® biomaterial [product identification records were not provided].Implant date: (b)(6) 2008.Description of hernia being treated: ¿during surgery there was significant recurrent incisional hernia by 2 inches in size on the left side of the mid abdomen with significant weakness of the incisional hernia that contained part of the colon and small bowel.Nevertheless, there was extensive peritoneal adhesions with greater omentum of the transverse colon as well as some of the small bowel loops.This was the presumptive cause for the ct findings to raise question of mild degree of superior mesenteric artery syndrome.¿ ¿transverse incision was made in the low epigastric region along with the existing scar.The incision was lengthened down to the fascial plane and the weakness from her hernia was noted along with separate hernia development through the left side of the previous scar.This small hernia is about 1.5 inches in size.The hernia sac was then incised in a transverse fashion and the peritoneum was carefully incised and the underlying adherent omentum and bowel loops were carefully and completely released from the undersurface of the surrounding peritoneal lining.¿ implant size and fixation: ¿the hernia defect on the left side of the scar area was clearly defined by releasing the surrounding soft tissue so as to delineate the fascial plane of this hernia defect which was then closed with multiple interrupted sutures of #1, non absorbable ethibond sutures.Again, the undersurface of the entire hernia defect was prepared and dual mesh was chosen, tailored, and placed underneath the hernia defect with a smooth surface facing the abdominal cavity.The repair was achieved with placement of multiple interrupted sutures of #1 ethibond sutures which carried through the full -thickness of the abdominal wall and catching the dualmesh.¿ ¿this suture technique with #1 ethibond sutures was repeated way around the hernia defect and then the sutures were tied properly so as to achieve the repair with mesh without undue tension.The fascia edges were also reapproximated with multiple interrupted sutures of #0 ethibond sutures.The wound was irrigated with sterile saline solution, hemostasis was complete.The wound was then closed with interrupted sutures of 2-0 and 3-0 vicryl sutures for the fascia and subcutaneous and staples for the skin.Sterile dressing was applied¿ no postoperative records.Explant preoperative complaints: (b)(6) 2008: ¿indications: the patient had previously had multiple abdominal procedures including cesarean section, laparoscopic cholecystectomy; repair of hernias multiple times with recent repair with mesh and lysis of adhesions for superior mesenteric artery syndrome.Two weeks after the procedure, the wound got infected and a culture showed mrsa for which she was placed on antibiotics for which it was sensitivity-guided.The infection gradually improved yet persistent.Therefore, the patient was admitted for surgical intervention at this time.¿ explant procedure: incision and drainage, deep debridement with removal of infected meshes, placement of vac suction apparatus.Explant date: (b)(6) 2008.¿a small penrose was removed and the wound was opened in transverse fashion about one inch above the umbilicus.The incision was deepened and the necrotic tissues were removed and the wound was thoroughly irrigated with sterile saline solution.Numerous ethibond suture were then removed and a pocket of abscess was noted approximately one inch in diameter which was irrigated after the culture was taken and then the infected mesh was noted which was then removed after the fascial plane was incised and all of the visible sutures removed.¿ ¿the two meshes were removed from the subfascial plane and the peritoneum was not entered.Again, the abscess cavity was irrigated after thorough debridement.Hemostasis was made complete and sterile gauze was then placed after the fascia was partially closed with 0 vicryl.A jp tube was placed on top of the gauze which was again covered with multiple sterile gauze and the entire wound and dressing were covered securely with tegaderm so as to create vacuum assisted closure while the jp tube was connected to suction apparatus.¿ relevant medical information: culture reports for specimens collected during the (b)(6) 2008 procedure were not provided.(b)(6) 2008: pathology report for specimen collected (b)(6) 2008: ¿specimen a.Mesh.The specimen labeled ¿mesh¿, and it consists of a portion of white, synthetic tissue, measuring 6.5 x 5.3 cm." conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warns : ¿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 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.¿ 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.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.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.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: updated health effect- clinical code.H6: updated investigation findings.H6: updated investigation conclusions.H6: health effect impact code: f1903.H6: conclusion code 4316: appropriate term/code not available for ¿withdrawn complaint¿.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span (b)(6) 2008 through (b)(6) 2017, and not all records received in this time span are relevant to the two gore® dualmesh® biomaterial implants.Records prior to (b)(6) 2008, including records for cesarean sections x3, cholecystectomy, repair of fascia (2007), and previous hernia repairs (2003, 2004, 2006, 2007) were not provided.Patient information: medical history: history of asthma.On (b)(6) 2008: acute recurrent incisional hernia.Prior surgical procedures: on (b)(6) 2003: history of cesarean section x3.History of multiple recurrent incisional hernia repairs 2003, 2004, 2006, 2007.On (b)(6) 2007: repair of fascia, cholecystectomy, bilateral tubal ligation.Implant preoperative complaints: pathology report dated (b)(6) 2008 for specimen collected (b)(6) 2008 [unknown procedure]: ¿a.Second portion duodenum biopsy: congestion, focal erosion and mild chronic nonspecific inflammation.B.Gastric antrum biopsy: mild nonspecific chronic inflammation.¿ (b)(6) 2008: preoperative/postoperative diagnosis ¿acute recurrent incisional hernia with partial incarceration of colon and small bowel loops, mild acute sma syndrome with adhesions.¿ (b)(6) 2008: ¿the patient had multiple abdominal surgeries including three c-sections, bilateral tubal ligation, repair of recurrent incisional hernias and cholecystectomy by laparoscopy, etc.About two months prior to admission at this time as the patient stated she was involved in a fight from which she fell on her lower back sustaining persistent progressive mid abdominal pain ever since.She was admitted on (b)(6) 2008 through the emergency room because of unbearable acute abdominal pain and a ct scan of the abdomen and pelvis revealed recurrent incisional hernia containing colon and small bowel loops without obstruction, therefore, the incarceration was partial.¿ on (b)(6) 2008: ¿meanwhile, a question of acute superior mesenteric artery syndrome was raised on the ct scan although there was no obstruction and the angle was not sharp enough to cualify [sic, qualify] for a syndrome.The patient was admitted for management and gi consultation was obtained.On june 4th it was determined to undergo the reduction and repair of the incarcerated incisional hernia along with lysis of the extensive adhesions.¿ implant procedure: reduction and repair with mesh implant for acute incarcerated incisional hernia with lysis of extensive adhesions.Implants: 2- gore® dualmesh® biomaterial [product identification records were not provided] implant date: (b)(6) 2008.Description of hernia being treated: ¿during surgery there was significant recurrent incisional hernia by 2 inches in size on the left side of the mid abdomen with significant weakness of the incisional hernia that contained part of the colon and small bowel.Nevertheless, there was extensive peritoneal adhesions with greater omentum of the transverse colon as well as some of the small bowel loops.This was the presumptive cause for the ct findings to raise question of mild degree of superior mesenteric artery syndrome.¿ ¿transverse incision was made in the low epigastric region along with the existing scar.The incision was lengthened down to the fascial plane and the weakness from her hernia was noted along with separate hernia development through the left side of the previous scar.This small hernia is about 1.5 inches in size.The hernia sac was then incised in a transverse fashion and the peritoneum was carefully incised and the underlying adherent omentum and bowel loops were carefully and completely released from the undersurface of the surrounding peritoneal lining.¿ implant size and fixation: ¿the hernia defect on the left side of the scar area was clearly defined by releasing the surrounding soft tissue so as to delineate the fascial plane of this hernia defect which was then closed with multiple interrupted sutures of #1, non-absorbable ethibond sutures.Again, the undersurface of the entire hernia defect was prepared and dual mesh was chosen, tailored, and placed underneath the hernia defect with a smooth surface facing the abdominal cavity.The repair was achieved with placement of multiple interrupted sutures of #1 ethibond sutures which carried through the full -thickness of the abdominal wall and catching the dualmesh.¿ ¿this suture technique with #1 ethibond sutures was repeated way around the hernia defect and then the sutures were tied properly so as to achieve the repair with mesh without undue tension.The fascia edges were also reapproximated with multiple interrupted sutures of #0 ethibond sutures.The wound was irrigated with sterile saline solution, hemostasis was complete.The wound was then closed with interrupted sutures of 2-0 and 3-0 vicryl sutures for the fascia and subcutaneous and staples for the skin.Sterile dressing was applied¿ no postoperative records.Explant preoperative complaints: on (b)(6) 2008: ¿indications: the patient had previously had multiple abdominal procedures including cesarean section, laparoscopic cholecystectomy; repair of hernias multiple times with recent repair with mesh and lysis of adhesions for superior mesenteric artery syndrome.Two weeks after the procedure, the wound got infected and a culture showed mrsa for which she was placed on antibiotics for which it was sensitivity-guided.The infection gradually improved yet persistent.Therefore, the patient was admitted for surgical intervention at this time.¿ explant procedure: incision and drainage, deep debridement with removal of infected meshes, placement of vac suction apparatus.Explant date: (b)(6) 2008.¿a small penrose was removed and the wound was opened in transverse fashion about one inch above the umbilicus.The incision was deepened and the necrotic tissues were removed and the wound was thoroughly irrigated with sterile saline solution.Numerous ethibond suture were then removed and a pocket of abscess was noted approximately one inch in diameter which was irrigated after the culture was taken and then the infected mesh was noted which was then removed after the fascial plane was incised and all of the visible sutures removed.¿ ¿the two meshes were removed from the subfascial plane and the peritoneum was not entered.Again, the abscess cavity was irrigated after thorough debridement.Hemostasis was made complete and sterile gauze was then placed after the fascia was partially closed with 0 vicryl.A jp tube was placed on top of the gauze which was again covered with multiple sterile gauze and the entire wound and dressing were covered securely with tegaderm so as to create vacuum assisted closure while the jp tube was connected to suction apparatus.¿ relevant medical information: culture reports for specimens collected during the (b)(6) 08 procedure were not provided.On (b)(6) 2008: pathology report for specimen collected (b)(6) 2008: ¿specimen a.Mesh.The specimen ¿.Labeled ¿mesh¿, and it consists of a portion of white, synthetic tissue, measuring 6.5 x 5.3 cm".Conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warns : ¿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 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.¿ 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.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.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.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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