|
|
| Model Number 1315020020 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
|
| Patient Problems
Adhesion(s) (1695); Not Applicable (3189); No Code Available (3191)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Added medical history.(b)(6).(b)(4).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.¿.
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2007 whereby a gore-tex® soft tissue patch was implanted.It was reported the patient alleges the following injuries: dissection of gore mesh from bowel, resection of bowel, additional surgery, extensive adhesions.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
B7: added medical history.H6: updated results code.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6)2002, including records detailing the ¿ventral hernia repairs in 1999 and 2002¿ noted in the (b)(6) 2007 records, were not provided.Operative records dated (b)(6)2002 indicate the patient underwent exploratory laparotomy, ileocecectomy, and small bowel stricturoplasty x 2 for a diagnosis of crohn¿s disease.Indications for the procedure state: ¿a 50-year-old male with crohn disease who has been refractory to medical therapy with obstructions on small bowel follow through which showed him to have severe terminal ileal disease.¿ findings from the procedure state: ¿1.Severe crohn disease of the terminal ileum and cecum.2.Two proximal small bowel strictures in areas of inactive crohn disease.¿ the (b)(6)2002 operative report states: ¿a midline laparotomy incision was made, and the abdominal cavity was entered sharply.On general inspection of the abdomen, his left colon, and the sigmoid appeared normal.Stomach appeared normal.Liver was normal.The patient had a previous cholecystectomy, and the right upper quadrant was normal.We then ran the small bowel from the ligament of treitz to the ileocecal valve.The proximal bowel was quite normal.However, at the terminal ileum there was noted to be very thickened mass with multiple intra-loop adhesions and very thickened mesentery with fat creeping consistent with crohn disease.¿ the (b)(6) 2002 operative records state: ¿we, therefore, resected approximately 45 cm of ileum by dividing with a gia stapler and the mesentery between kelly clamps.The mesentery was quite thickened.There was significant bleeding that required control with 0 prolene and 2-0 silk sutures.We then divided the colon at the junction of the ascending colon and cecum with gia stapler, then divided the mesentery with kelly clamps and removed the specimen.¿ the (b)(6)2002 operative report states: ¿we then, using a foley balloon with the balloon blown up to 2.5 cm diameter, ran the small intestine internally looking for occult strictures.We were able to identify 2 areas of stricturing where we were unable to pass the balloon in the distal jejunum and the proximal jejunum.There was no evidence of any active crohn disease in these areas.It was therefore elected to perform a stricturoplasty in these areas in a heineke-mikulicz fashion, making a longitudinal enterotomy and then closing the bowel in 2 layers with running 3-0 vicryl and then 3-0 silk lemberts transversely.At each stricture site, we then placed 2 metal clips in order to mark the area.Once this was done, we then completed the ileocolostomy.This was done in an end colon to the side of small bowel, fashioned in 2 layers with an outer layer of 3-0 silk lemberts and inner layer of running 3-0 vicryl.Once the anastomosis was completed, the mesentery was closed with interrupted 3-0 silk sutures.We then irrigated out the abdomen with several liters of saline solution.The fascia was then closed with running 0 loop nylon, and the skin was closed with skip clips.¿ records dated (b)(6) 2007 indicate the patient was seen for a pre-operative evaluation prior to a hernia repair.¿this is a 55-year-old male with a history of a ventral hernia for approximately the last 5 years.He has had this hernia repaired twice before.He is a patient of dr.(b)(6) in gastroenterology for his crohn¿s disease, but has not had any significant difficulties with his crohn¿s, only this recurrent hernia.¿ the records note the following past medical history: ¿1.Crohn disease diagnosed 23 years ago.2.History of multiple kidney stones.3.Status post laparoscopic cholecystectomy.4.Arthritis.5.Partial colectomy and small-bowel resection in august of 2002.6.Ventral hernia repairs in 1999 and 2002.7.Fistulotomy, march of 2001.¿ records for the ventral hernia repairs performed in 1999 and 2002 were not provided.Notes from the (b)(6)2007 visit state: ¿the patient has mild abdominal pain and bloating, especially when the hernia is protruding.Patient denies all other issues, other than arthralgias, which are ongoing.¿ ¿this is a well-appearing middle-aged male.He is alert, oriented, in no acute distress and has a normal body habitus with some central obesity.¿ weight is noted as 216 pounds.¿abdomen: there is an easily-reducible hernia just left of midline in the lower abdomen.There is definitely intestine within the hernia sac, as there are bowel sounds within the hernia.He has a somewhat obese abdomen, but it is nondistended and soft.It is somewhat tender when you reduce the hernia.¿ ¿this is a 55-year-old male with a recurrent incisional hernia which is currently reducible.¿ operative records dated (b)(6)2007 state the patient underwent recurrent ventral hernia repair with mesh.¿this patient has a history of crohn¿s disease.He underwent an exploratory laparotomy with resection of small bowel.He has a postoperative wound infection and now presents with recurrent ventral hernia, as he had had an attempt at repair x1.¿ the (b)(6) 2007 operative report states: ¿he had at least 2 separate hernias, which were identified.One was lateral and superior.The other one is periumbilical into the patient¿s left side.His midline wound was reopened.There was a swiss cheese appearance to the fascia beneath it at each of the sites where the looped 0 nylon had been brought through the fascia.Adhesions were taken down and the omentum was freed up of the patient¿s fascia.A 15- x 20-cm sheet of ptfe was trimmed to fit the fascia defect and was secured in placed posterior to the fascia using interrupted 0 prolene sutures.Following placement of the ptfe mesh, the fascia was closed using running looped 0 maxon.Subcutaneous tissue was anaesthetized using 30 cc of 0.5% marcaine.The skin was closed using a running intercuticular 4-0 monocryl.¿ a handwritten operative note indicates a gore-tex® soft tissue patch (1315020020/04528369) was implanted during the procedure.Discharge summary records dated (b)(6)2007 state: ¿following his (b)(6)2007] procedure, the patient was transferred to the floor to continue his recovery.The patient initially did well.Patient did complain of some pain, primarily with deep inspiration, but denied any nausea, vomiting, or other complaints.The patient was tolerating a diet and was able to ambulate without difficulty.Patient did have a febrile episode on the day following his procedure; however, this resolved and did not recur during his stay.Patient did also have some issues with urinary retention following his surgery, and a foley catheter was placed.This was ultimately discontinued on (b)(6) 2007, and the patient was able to void.By (b)(6)2007, the patient was feeling well, his pain was well controlled, he was able to ambulate without difficulty, and he was tolerating a general diet.¿ records between (b)(6)2007 and (b)(6)2014 were not provided.A discharge summary dated (b)(6)2014 indicates the patient was admitted to the hospital on (b)(6)2014 for ¿partial small bowel obstruction, hx of crohn¿s disease.¿ records detailing the patient¿s hospital course prior to (b)(6)2014 were not provided.Records dated (b)(6)2014 detail the following medical history: ¿dr.(b)(6): (b)(6) 2013.Postoperative diagnosis(es): anal stenosis.Crohn disease.Procedure performed: dilation of anal stenosis.¿ ¿dr.(b)(6): (b)(6) 2007) postoperative diagnosis: recurrent ventral hernia.Procedures performed: recurrent ventral hernia repair with ptfe mesh.¿ ¿dr.(b)(6): (b)(6)2002) 1.Exploratory laparotomy.2.Ileocecectomy (resected approximately 45 cm of ileum).3.Small bowel stricturoplasty x 2.¿ ¿dr.(b)(6): (b)(6) 2001) done for chronic draining abscess of his right anterior perineum.1.Examination under anesthesia.2.Fistulotomy.3.Transection of skin bridge of the anoderm causing partial anal stenosis.¿ records from (b)(6)2014 also detail the following prior test results: [date/type of test not provided, results cut off] ¿¿enhancement suggest active.2.Small amount of free fluid in the pelvis.3.Hepatic steatosis.4.Unchanged small fat-containing ventral hernias adjacent to the surgical mesh.5.Partially visualized, unchanged left perianal fistula.6.New nonobstructing punctate left renal stone.7.Enteric tube with tip in the stomach.¿ ¿ct [abdomen]/pelvis(b)(6)2013 during hospitalization: 1.Acute, long segment, proximal ileitis with sbo.This finding is c/w active crohn¿s disease, with a stricture as the likely cause of obstruction.2.Hepatic steatosis.3.Multiple fat and omentum containing hernias along the left lateral margin of the ventral abdominal mesh.4.Partially imaged left perianal fistula, age-indeterminate.¿ ¿cte: (b)(6)2009: abnormal enhancement and wall thickening of the distal 15 cm of the patient¿s terminal ileum.This is consistent with active crohn disease.The terminal ileum appears to enter the patient¿s colon in what appears to be an ileocecostomy.Please correlate with the patient¿s surgical history.¿ ¿endoscopic history: colonoscopy: (b)(6)2013.Impression: 1.Markedly stenosed anal canal, dilated by dr.(b)(6)2.Neo-ti/anastomosis, type: end to end, recurrence score: i3 = diffuse aphthous ileitis and diffusely inflamed mucosa in the neo-ti, without stricture, could only advance about 5 cm into the neo ti as i was retroflexed in order to enter the upstream limb.¿ operative records dated (b)(6) 2014 indicate the patient underwent ¿1.Extensive lysis of adhesions.2.Neoterminal ileal resection with end-to-end anastomosis.¿ postoperative diagnoses are noted as ¿1.Partial small-bowel obstruction.2.Crohn disease.3.History of intraabdominal placement of mesh for ventral hernia repair.¿ ¿this patient has a history of inflammatory bowel disease.He developed a ventral hernia postoperatively and was treated at an outside hospital with intraperitoneal placement of ptfe mesh.He now presents with recurrent crohn disease, having suffered from several bowel obstructions in the last few months, for resection.¿ findings from the procedure: ¿extensive adhesions of bowel to mesh and external sequelae of crohns disease at neo ti.¿ the (b)(6) 2014 operative report states: ¿he had intravenous steroids with iv fluid administration, which resulted in opening up of his small-bowel obstruction.¿ ¿his midline incision was palpable, and at the area just above the umbilicus you could palpate the ptfe mesh.This corresponded with the location of the mesh on the patient¿s ct imaging.The lower midline incision was opened.Adhesions were taken down using sharp and blunt dissection.We were able to lyse all of the adhesions in the lower abdomen, and the patient continued to have an area of thickened small bowel in the mid abdomen adjacent to where the patient¿s mesh had been located.We ultimately needed to take the bowel off of the overlying gore-tex mesh.Using sharp and blunt dissection, we were able to accomplish this without causing a bowel injury; however, the adhesions were quite tenacious.¿ the (b)(6)2014 operative records continue: ¿the small bowel loop was identified.The hepatic flexure was mobilized once this loop of bowel had been freed up from the overlying mesh, and we were able to mobilize this loop of involved small bowel.On the patient¿s prior colonoscopy, he had an i3 recurrence.We transected the ascending colon as well as the neoterminal ileum proximal to the patient¿s stenotic area.This resulted in a resection of approximately 8 inches of small bowel.The patient tolerated this well.We were able to open up the small bowel and run a catheter through the distal small bowel.No additional strictures were identified that were obstructing the patient bowel.There was an area that was closely adjacent to the patient¿s transection point, which had some crohn disease apparent within it; however, there was no obstruction from this area, and we elected not to perform an additional resection.The small bowel was then anastomosed to the colon using an outer layer of 2-0 vicryl and an inner layer of 3-0 chromic.¿ the (b)(6)2014 operative report states: ¿the abdomen was irrigated with saline, followed by irrisept, a dilute solution of chlorhexidine.The abdomen was closed using an interrupted prolene at the apex of the mesh.The remainder of the abdomen was closed using a running looped 0 maxon.The subcutaneous tissue was anaesthetized using 30 cc of 0.5% marcaine.The subcutaneous tissue then had a 120 cc on-q pump placed.The skin was closed using a running intracuticular 4-0 monocryl.¿ the records indicate a genzyme biosurgery seprafilm® (adhesion barrier) was used during the procedure.There was no mention of gore device removal in the records.Progress notes dated (b)(6)2014 state the patient was seen for follow up ¿¿after undergoing a extensive loa and ileocolonic resection of 8 inches of nti on 02/17/2014.The patient is doing well.¿ ¿bowel function: much reduced in number and no semi-solid ¿ taking welchol.Pain: improving; only taking 4 oxycodone daily.Incision: clean/dry/intact.No signs of infection.¿ progress notes dated (b)(6)2014 state: ¿i saw and evaluated [the patient], 62 y, male on (b)(6)2014 with crohn¿s disease who¿s [sic] disease progressed to an obstruction while on humira so we will have to keep a close eye on his disease and scope him at 6 months, sooner is symptoms [sic].¿ 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-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.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
| |
|
Manufacturer Narrative
|
|
H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (1695, 3191: appropriate term/code not available for ¿dissection of gore mesh from bowl¿ and ¿resection of bowel¿) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span august 22, 2002 through june 12, 2014 and not all records received in this time span are relevant to the gore-tex® soft tissue patch.Records from august 23, 2002 through may 16, 2007; from june 4, 2007 through february 10, 2014 were not provided.Patient information: medical history: crohn¿s disease, anal stenosis, renal calculi.Prior surgical procedures: cholecystectomy [unknown date], on (b)(6) 2001: fistulotomy, on (b)(6) 2002: ileocecectomy, on (b)(6) 2002: small bowel stricturoplasty x2, 1999, 2002: ventral hernia repair.Relevant medical information: on (b)(6) 2002: exploratory laparotomy, ileocecectomy and small bowel stricturoplasty x2.¿a 50-year-old male with crohn disease who has been refractory to medical therapy with obstructions on small bowel follow through which showed him to have severe terminal ileal disease.¿ ¿a midline laparotomy incision was made, and the abdominal cavity was entered sharply.On general inspection of the abdomen, his left colon, and the sigmoid appeared normal.Stomach appeared normal.Liver was normal.The patient had a previous cholecystectomy, and the right upper quadrant was normal.We then ran the small bowel from the ligament of treitz to the ileocecal valve.The proximal bowel was quite normal.However, at the terminal ileum there was noted to be very thickened mass with multiple intra-loop adhesions and very thickened mesentery with fat creeping consistent with crohn disease.We, therefore, resected approximately 45 cm of ileum by dividing with a gia stapler and the mesentery between kelly clamps.The mesentery was quite thickened.There was significant bleeding that required control with 0 prolene and 2-0 silk sutures.We then divided the colon at the junction of the ascending colon and cecum with gia stapler, then divided the mesentery with kelly clamps and removed the specimen.We then, using a foley balloon with the balloon blown up to 2.5 cm diameter, ran the small intestine internally looking for occult strictures.We were able to identify 2 areas of stricturing where we were unable to pass the balloon in the distal jejunum and the proximal jejunum.There was no evidence of any active crohn disease in these areas.It was therefore elected to perform a stricturoplasty in these areas in a heineke-mikulicz fashion, making a longitudinal enterotomy and then closing the bowel in 2 layers with running 3-0 vicryl and then 3-0 silk lemberts transversely.At each stricture site, we then placed 2 metal clips in order to mark the area.Once this was done, we then completed the ileocolostomy.This was done in an end colon to the side of small bowel, fashioned in 2 layers with an outer layer of 3-0 silk lemberts and inner layer of running 3-0 vicryl.Once the anastomosis was completed, the mesentery was closed with interrupted 3-0 silk sutures.We then irrigated out the abdomen with several liters of saline solution.The fascia was then closed with running 0 loop nylon, and the skin was closed with skip clips.¿ implant preoperative complaints: on (b)(6) 2007: ¿this is a 55-year-old male with a history of a ventral hernia for approximately the last 5 years.He has had this hernia repaired twice before.He is a patient of dr.(b)(6) in gastroenterology for his crohn¿s disease, but has not had any significant difficulties with his crohn¿s, only this recurrent hernia.¿ on (b)(6) 2007: ¿the patient has mild abdominal pain and bloating, especially when the hernia is protruding.Patient denies all other issues, other than arthralgias, which are ongoing.¿ ¿this is a well-appearing middle-aged male.He is alert, oriented, in no acute distress and has a normal body habitus with some central obesity.¿ ¿abdomen: there is an easily-reducible hernia just left of midline in the lower abdomen.There is definitely intestine within the hernia sac, as there are bowel sounds within the hernia.He has a somewhat obese abdomen, but it is nondistended and soft.It is somewhat tender when you reduce the hernia.¿ on (b)(6) 2007: ¿this patient has a history of crohn¿s disease.He underwent an exploratory laparotomy with resection of small bowel.He has a postoperative wound infection and now presents with recurrent ventral hernia, as he had an attempt at repair x1.¿ implant procedure: recurrent ventral hernia repair with mesh.Implant: gore-tex® soft tissue patch (04528369/1315020020) 15 cm x 20 cm x 2 mm.Implant date: on (b)(6) 2007 [hospitalization on (b)(6) 2007].Description of hernia being treated: ¿he had at least 2 separate hernias, which were identified.One was lateral and superior.The other one is periumbilical into the patient¿s left side.His midline wound was reopened.There was a swiss cheese appearance to the fascia beneath it at each of the sites where the looped 0 nylon had been brought through the fascia.Adhesions were taken down and the omentum was freed up of the patient¿s fascia.¿ implant size and fixation: ¿a 15-x 20-cm sheet of ptfe was trimmed to fit the fascia defect and was secured in placed posterior to the fascia using interrupted 0 prolene sutures.Following placement of the ptfe mesh, the fascia was closed using running looped 0 maxon.Subcutaneous tissue was anaesthetized using 30 cc of 0.5% marcaine.The skin was closed using a running intercuticular 4-0 monocryl.¿ post-operative period: [4 days].On (b)(6) 2007: discharge summary: ¿following his [on (b)(6) 2007] procedure, the patient was transferred to the floor to continue his recovery.The patient initially did well.Patient did complain of some pain, primarily with deep inspiration, but denied any nausea, vomiting, or other complaints.The patient was tolerating a diet and was able to ambulate without difficulty.Patient did have a febrile episode on the day following his procedure; however, this resolved and did not recur during his stay.Patient did also have some issues with urinary retention following his surgery, and a foley catheter was placed.This was ultimately discontinued on (b)(6) 2007, and the patient was able to void.By on (b)(6) 2007, the patient was feeling well, his pain was well controlled, he was able to ambulate without difficulty, and he was tolerating a general diet.¿ relevant medical information: on (b)(6) 2014: records indicate the following medical history: ¿dr.(b)(6) (on (b)(6) 2013) postoperative diagnosis(es): anal stenosis.Crohn disease.Procedure performed: dilation of anal stenosis.¿ ¿dr.(b)(6) (on (b)(6) 2007) postoperative diagnosis: recurrent ventral hernia.Procedures performed: recurrent ventral hernia repair with ptfe mesh.¿ ¿dr.(b)(6) (on (b)(6) 2002) 1.Exploratory laparotomy.2.Ileocecectomy (resected approximately 45 cm of ileum).3.Small bowel stricturoplasty x 2.¿ ¿dr.(b)(6) (on (b)(6) 2001) done for chronic draining abscess of his right anterior perineum.1.Examination under anesthesia.2.Fistulotomy.3.Transection of skin bridge of the anoderm causing partial anal stenosis.¿ on (b)(6) 2014: records indicate the following diagnostic results: [date/type of test not provided, results cut off] ¿enhancement suggest active.2.Small amount of free fluid in the pelvis.3.Hepatic steatosis.4.Unchanged small fat-containing ventral hernias adjacent to the surgical mesh.5.Partially visualized, unchanged left perianal fistula.6.New nonobstructing punctate left renal stone.7.Enteric tube with tip in the stomach.¿ on (b)(6) 2013: ct abdomen/pelvis: ¿1.Acute, long segment, proximal ileitis with sbo [small bowel obstruction].This finding is c/w [consistent with] active crohn¿s disease, with a stricture as the likely cause of obstruction.2.Hepatic steatosis.3.Multiple fat and omentum containing hernias along the left lateral margin of the ventral abdominal mesh.4.Partially imaged left perianal fistula, age-indeterminate.¿ on (b)(6) 2009: ct enterograhy: ¿abnormal enhancement and wall thickening of the distal 15 cm of the patient¿s terminal ileum.This is consistent with active crohn disease.The terminal ileum appears to enter the patient¿s colon in what appears to be an ileocecostomy.Please correlate with the patient¿s surgical history.¿ on (b)(6) 2013: colonoscopy: ¿1.Markedly stenosed anal canal, dilated by dr.(b)(6).2.Neo-ti/anastomosis, type: end to end, recurrence score: i3 = diffuse aphthous ileitis and diffusely inflamed mucosa in the neo-ti, without stricture, could only advance about 5 cm into the neo ti as i was retroflexed in order to enter the upstream limb.¿ on (b)(6) 2014: extensive lysis of adhesions, neoterminal ileal resection with end-to-end anastomosis ¿this patient has a history of inflammatory bowel disease.He developed a ventral hernia postoperatively and was treated at an outside hospital with intraperitoneal placement of ptfe mesh.He now presents with recurrent crohn disease, having suffered from several bowel obstructions in the last few months, for resection.¿ ¿extensive adhesions of bowel to mesh and external sequelae of crohn¿s disease at neo ti [terminal ileum].¿ ¿he had intravenous steroids with iv fluid administration, which resulted in opening up of his small-bowel obstruction.¿ ¿his midline incision was palpable, and at the area just above the umbilicus you could palpate the ptfe mesh.This corresponded with the location of the mesh on the patient¿s ct imaging.The lower midline incision was opened.Adhesions were taken down using sharp and blunt dissection.We were able to lyse all of the adhesions in the lower abdomen, and the patient continued to have an area of thickened small bowel in the mid abdomen adjacent to where the patient¿s mesh had been located.We ultimately needed to take the bowel off of the overlying gore-tex mesh.Using sharp and blunt dissection, we were able to accomplish this without causing a bowel injury; however, the adhesions were quite tenacious.The small bowel loop was identified.The hepatic flexure was mobilized once this loop of bowel had been freed up from the overlying mesh, and we were able to mobilize this loop of involved small bowel.On the patient¿s prior colonoscopy, he had an i3 recurrence.We transected the ascending colon as well as the neoterminal ileum proximal to the patient¿s stenotic area.This resulted in a resection of approximately 8 inches of small bowel.The patient tolerated this well.We were able to open up the small bowel and run a catheter through the distal small bowel.No additional strictures were identified that were obstructing the patient bowel.There was an area that was closely adjacent to the patient¿s transection point, which had some crohn disease apparent within it; however, there was no obstruction from this area, and we elected not to perform an additional resection.The small bowel was then anastomosed to the colon using an outer layer of 2-0 vicryl and an inner layer of 3-0 chromic.The abdomen was irrigated with saline, followed by irrisept, a dilute solution of chlorhexidine.The abdomen was closed using an interrupted prolene at the apex of the mesh.The remainder of the abdomen was closed using a running looped 0 maxon.The subcutaneous tissue was anaesthetized using 30 cc of 0.5% marcaine.The subcutaneous tissue then had a 120 cc on-q pump placed.The skin was closed using a running intracuticular 4-0 monocryl.¿ records indicate a non-gore device was implanted during on (b)(6) 2014 procedure.Records do not indicate that the gore device was removed during on (b)(6) 2014 procedure.On (b)(6) 2014: ¿after undergoing a [sic] extensive loa [lysis of adhesions] and ileocolonic resection of 8 inches of nti [neoterminal ileum] on (b)(6) 2014.The patient is doing well.¿ ¿bowel function: much reduced in number and no semi-solid ¿taking welchol.Pain: improving; only taking 4 oxycodone daily.Incision: clean/dry/intact.No signs of infection.¿ on (b)(6) 2014: ¿i saw and evaluated [the patient], 62 y, male on (b)(6) 2014 with crohn¿s disease who¿s [sic] disease progressed to an obstruction while on humira so we will have to keep a close eye on his disease and scope him at 6 months, sooner is symptoms [sic].¿ conclusions: it should be noted that the gore-tex® soft tissue patch instructions for use include warnings and addresses the following adverse reactions among others: ¿possible complications with the use of any tissue deficiency prosthesis may include, but are not limited to, infection, seroma formation, adhesions, hematomas, inflammation, fistula formation and recurrence.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.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.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, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
| |
|
Search Alerts/Recalls
|
|
|
