| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Not Applicable (3189)
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| Event Date 05/12/2015 |
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Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.The initial reporter's complete address is (b)(6).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: ¿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 hernia repair (type unknown) on an unknown date whereby an alleged ¿gore-tex¿ device was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: adhesions, infection, mesh removal, additional surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history h6: 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.Conclusion codes remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records for the prior ¿hernia repair with mesh¿ noted in the 5/5/2007 records were not provided.There are no records detailing the implant of a ¿gore-tex¿ mesh, as mentioned in the 5/12/2015 operative report.Additionally, there are no product identification records for the alleged ¿gore-tex¿ mesh.Records dated 10/19/2000 state: ¿she continues to have intermittent right upper quadrant pain, nausea, as well as pain at her periumbilical region where she has an incarcerated hernia.¿ operative records dated 10/27/2000 state the patient underwent repair of an incarcerated umbilical hernia and laparoscopic cholecystectomy.Postoperative diagnoses are noted as incarcerated umbilical hernia, cholelithiasis, and chronic cholecystitis.The records state: ¿¿a curvilinear incision was made below the umbilicus and carried down through the subcutaneous tissue with electrocautery and blunt dissection.The hernia sac was dissected off the overlying umbilical skin and dissection was carried down to the fascial edges.These were clearly delineated and the hernia sac was transected and the incarcerated omentum was reduced.With the fascial edges well denoted, 0 ethibond sutures were placed laterally on both sides and hasson trocar was placed through this and secured.Pneumoperitoneum was established.The remaining subcostal trocars were placed under direct vision.The gallbladder was identified, chronically inflamed with omental adhesions to this.¿ excerpts from the gallbladder removal included: ¿the fundus was grasped, retracted cephalic, adhesions were taken down.It was noted that there was some bleeding coming from the epigastric port.This appeared to be fairly vigorous and concerning.¿ ¿it was noted to be technically difficult due to her size and transverse colon was getting in the way making it difficult to see the neck of the gallbladder.Once the adhesions were taken down, this required use of the thirty degree angled scope, the gallbladder was falling down on its neck to the point where the cystic duct was identified.¿ ¿attention was turned towards finding the cystic artery.This was not readily apparent such that the fundus was taken down from the gallbladder using electrocautery and blunt dissection¿ the gallbladder was removed from the umbilical incision.¿ ¿trocars were placed.Pneumoperitoneum established and trocars were then removed from their subcostal locations under direct vision.No bleeding was noted with all trocars out, the fascia from the epigastric port was closed with 0 vicryl figure of eight suture and the umbilical hernia was repaired with #1 ethibond interrupted sutures.It was noted that marcaine was injected around all trocar sites and the skin was then approximated with 4-0 monocryl subcuticular stitch.¿ there was no mention of a mesh device being implanted during the 10/27/2000 procedure.Records dated 11/6/2000 state the ¿is status post laparoscopic cholecystectomy with repair of a ventral hernia.She is doing well with resolution of the abdominal pain that she had preoperatively; however, complains of ge reflux and nausea.Abdomen is soft, nontender.Incision is clean, dry, and healing nicely.She has had no fevers and bowel functions are present.¿ records between 2000 and 2003 were not provided.Records dated 8/12/2003 state a ct was performed for a history of vomiting and abdominal pain.¿no free air or free fluid is seen within the abdomen.Note is made of a ventral hernia at the level of the umbilicus which contains small bowel and there is dilatation of proximal small bowel leading into this with normal decompressed small bowel extending out.Findings are consistent with an obstructing umbilical hernia.No adenopathy is seen in the abdomen or pelvis.¿ ¿impression: umbilical ventral hernia producing obstruction of proximal small bowel as described above.No associated free air or pneumotosis is noted.¿ discharge summary records dated 8/16/2003 state the patient was admitted to the hospital on 8/12/2003.¿the patient is a 53 year old female, who presented to the emergency room with abdominal pain and found to have incarcerated incisional hernia.Had been having nausea and vomiting for a few days and taken to the or and found to have incarcerated hernia with gangrenous bowel.Bowel resection was performed.Hernia was repaired.Postoperatively, she has done well.¿ operative records for a procedure performed on 8/12/2003 were not provided.History and physical record indicates ¿plan: repair with mesh¿ however there are no records detailing the implant of a mesh device.Pathology records dated 8/14/2003 regarding ¿incarcerated incisional hernia¿ specimens collected 8/12/2003 state: ¿final diagnosis: periumbilical peritoneus, herniorrhaphy ¿ acute and chronic inflammation with granulation tissue formation consistent with incarcerated hernia.No evidence of neoplastic or ectopic tissue rest.¿ records dated 8/26/2003 state the patient ¿is in for postop following repair of incarcerated hernia with bowel resection.She has done well and has no complaints.¿ ¿the incision is clean and dry.Appetite is good.Bowel function is normal.¿ records between 2003 and 2007 were not provided.History and physical records dated 5/5/2007 state the patient ¿.Presented to the emergency room this morning with abdominal pain, nausea, vomiting.She was found to have a hernia and radiographic signs of a bowel obstruction.She was admitted for iv fluids and nasogastric decompression.¿ ¿past surgical history: includes a previous hernia repair and a history of phlebitis.She has had hernia repair with mesh.¿ operative records dated 5/6/2007 indicate the patient underwent: ¿1) repair of recurrent incarcerated incisional hernia x two with mesh.2) omentectomy.3) repair of enterotomy.¿ postoperative diagnoses are ¿1) recurrent incarcerated incisional hernia x two.2) ischemic incarcerated omentum.¿ the 5/6/2007 records state: ¿entrance gained through the previous incision around the umbilicus where the hernia was present protruding off to the right side.With the skin incised electrocautery was used for dissection down through subcutaneous tissue and the hernia sac was identified and opened.Incarcerated omentum and bowel was present.This was freed up via blunt and sharp dissection using electrocautery for hemostasis.A serosal tear was noted in the bowel and this was repaired with 3-0 silk lembert sutures.Some devitalized omentum was present and this was excised using electrocautery.With this done the hernia sac was excised to define the fascial edges.Mesh was noted superiorly as well as some inferiorly.The fascia was noted laterally on both sides.The small bowel was inspected and appeared fairly normal without evidence of an obstructive process.¿ the 5/6/2007 records continue: ¿dissection was carried out further underneath the mesh and another hernia was present in the epigastric area.The incision was extended superiorly to define this area and a hernia was present.The hernia sac was excised and incarcerated bowel was reduced.With the fascial edges defined it was felt that these both could be repaired with mesh.There was mesh present in the lower hernia that was attached to fascia and mesh inferiorly using #1 ethibond interrupted sutures thereby repairing this hernia.Prolene mesh was placed in the superior aspect and sewn to the fascial edges circumferentially with #1 prolene running suture.With this done the area was irrigated, hemostasis was adequate.A j-p drain was placed, secured with 3-0 nylon.The subcutaneous tissues were approximated with 3-0 monocril running sutures, the skin was approximated with stapler.¿ the records indicate a prolene (non-gore) mesh was implanted during the procedure.Pathology records dated 5/7/2007 regarding a specimen collected 5/6/2007 states: ¿recurrent incarcerated hernia.¿ ¿gross description: received in formalin as ¿hernia sac¿ are three irregular shaped fragments of soft pin-tan connective tissue measuring in aggregate 6.5 x 5.5 x 2.1 cm.¿ ¿sections reveal a hernia sac composed of a delicate fibrous membrane covered by reactive mesothelial cells.An occasional perivascular infiltrate of lymphocytes is present.Final diagnosis: abdominal wall (resection): hernia sac.¿ a handwritten note dated 5/22/2007 states: ¿post-op [repair] recurrent [incarcerated] [incisional] hernia x2 [with] mesh, omentectomy, repair of enterotomy @ wrmc on 5/6/2007.Staples intact.Denies any pain or discomfort.¿ records between 2007 and 2010 were not provided.Records dated 8/10/2010 indicate the patient was seen for right flank pain with nausea and vomiting.Ct records state: ¿multiple metallic clips are associated with mesh repair of a ventral hernia.A 4 cm ventral hernia lies just superior to the mesh.This contains a normal appearing segment of transverse colon.Surgical clips are present secondary to a cholecystectomy.Metallic hardware is seen in the lower lumbar spine.Sections through the pelvis reveals surgical clips on the right.¿ ¿impression: ventral hernia.¿ records dated 3/23/2011 state: ¿[the patient] is in with a recurrent hernia in her epigastric area.She had 2 previous hernias addressed repaired with mesh.She is not having significant gi complaints but having some discomfort.She is morbidly obese, weight 255 lb.I discussed the importance of her being in good shape before elective surgery as well as losing some weight to help make the operation somewhat easier as well as her chances of recurrence less.¿ records dated 1/11/2012 state the patient was seen ¿for evaluation of abdominal hernia.This has been bothering her a fair bit.She states she has been having some abdominal discomfort into the groins.No gi or urological symptoms.She has lost a little bit of weight at this point and she would like to have the hernia repaired.¿ operative records dated 1/26/2012 state the patient underwent ¿1.Robotic-assisted laparoscopic repair of the incarcerated recurrent incisional hernia.2.Laparoscopic repair of ventral hernia.3.Utilization of mesh for repair of recurrent incarcerated hernia.¿ postoperative diagnoses are noted as recurrent incarcerated incisional hernia and ventral hernia.The 1/26/2012 records state: ¿the patient had a hernia in the epigastric area, somewhat to the left.It was decided to enter on the left side of the abdomen, and a 12 visiport was used to enter the left flank approximately 15 cm to 20 cm from the midline.With this, pneumoperitoneum was established, and adhesions were noted to the lower abdominal area.An 8 mm trocar was placed in the left upper quadrant and sharp dissection was utilized laparoscopically to take down adhesions in the left lower quadrant to the point where the third trocar could be placed.An 8 mm trocar was placed in the left lower quadrant.With this, the patient cart was brought to the patient and docked with the trocars.Instrumentation was inserted with the camera using a 30 degree upscope and bipolar grasper and hot shears.Dissection was carried out to free the incarcerated omentum and bowel from the hernia.This was done without too much difficulty.There was concern for another hernia inferiorly, such that adhesions were taken down inferiorly to the anterior abdominal wall.Here, it appeared that she had had some mesh placed that may have been biosynthetic.¿ the 1/26/2012 operative report continues: ¿she had another piece of marlex mesh placed in the upper abdomen that was visualized and still intact but served as a border to the hernia.The adhesions were taken down and another ventral hernia was noted.This appeared to be small enough to be repaired with suture.With all the adhesions taken down, the 3 x 6 piece of mesh that had been placed at the beginning of the procedure on getting the trocars in place, and it became apparent that this was not big enough for the hernia, such that i scrubbed back in and removed that mesh and placed a 6 x 6 piece of mesh intra-abdominally with 5 #1 prolene sutures and a 3-0 silk suture in the abdominal cavity.I then returned to surgeon's console and placed the mesh, securing this circumferentially with #1 prolene interrupted sutures.With this done, a #1 prolene suture was placed in the ventral hernia inferiorly using figure-of-eight suture.With this secured, i scrubbed back in and used the protacker to secure the mesh additionally outside the hernia defect and in between the sutures.¿ the records indicate two pieces of bard mesh (non-gore) were used during the procedure, one of which was removed (3 x 6 piece) due to not being of adequate size to cover the hernia defect.Records dated 2/8/2012 state: ¿postop check following robotic-assisted laparoscopic hernia repair.She is doing fairly well.She still has some discomfort.She is tolerating po.Bowel function has returned to normal.Abdomen is soft with slight bit of fullness at the area of her previous hernia.There is no transmission of intra-abdominal pressure and i believe we are dealing with a seroma.At this point it is not bothering her and we will watch this.¿ records dated 2/27/2012 state the patient was seen ¿for postop check following laparoscopic repair of recurrent incisional hernia with robotic assistance.She is doing fairly well, having some discomfort and some nausea and has on exam a fullness at her previous hernia site.No signs of infection.Incision is clean, dry and healing nicely.She has no peritoneal signs.At this point i believe we are dealing with a seroma but we need to exclude the possibility of recurrent hernia given her symptoms.We will obtain a ct scan and see her back in the office.¿ ct records dated 3/9/2012 state: ¿indication: nausea vomiting and diarrhea in patient with oval mass anterior abdominal wall, status post recent umbilical hernia surgery, 5 weeks previously.Additional history lumbar spine surgery, multiple prior hernia repairs, tubal ligation, cholecystectomy, and kidney stone removal.¿ ¿opaque material in anterior abdominal wall compatible with multiple prior surgical procedures as correlated with history.Currently, no discrete hernia defect evident, stranding observed in the anterior bowel wall and along the fascia.Deep to the bb, homogeneous water density fluid collection 5 hu, measuring 5 cm ap, and 7 cm mediolateral and superior-inferior dimension.Probable benign postop seroma with no wall thickening, or gas accumulation evident and arthritic changes and postop changes noted in spine.¿ records dated 3/12/2012 state the patient was seen ¿for re-evaluation and review of ct scan of her abdomen to evaluate the firmness in her abdominal wall.This is in the hernia site and ct revealed a seroma.No evidence of bowel in this area.She has been doing a little bit better, occasional nausea still but less discomfort.She looks good.She is offered aspiration and 80 cc of serosanguinous fluid is removed from this area percutaneously.¿ records dated 3/19/2012 state the patient was seen for ¿re-evaluation of her abdominal wall.She has fullness here consistent with recurrent seroma.The skin is prepped with alcohol and needle aspiration is performed removing 45 cc of serosanguineous fluid.She is otherwise doing well.Abdomen is soft and nontender.¿ records dated 3/26/2012 state: ¿she underwent drainage a week ago of seroma.It has recurred and causes occasional discomfort.I have recommended drainage with a jp drain to resolve this issue.¿ operative records dated 3/28/2012 state the patient underwent excision of seroma and hernia sac.Postoperative diagnosis states: ¿abdominal wall seroma involving hernia sac, status post laparoscopic hernia repair.¿ ¿mass was present just to the left of midline in epigastric area.A transverse incision was made over this ___ [sic] resection out through subcutaneous tissue and the sac was read circumferentially down to fascial edge.It was opened and contained serous fluid as well as debris that appeared to be consistent with ___ [sic] material as well as old thrombus with the fat drained.It was taken down to near fascial edge and the mesh seem to be intact in the repair with no evidence of recurrent herniation with the sac excised.It was then closed with a running locking 2-0 vicryl suture transversally.With this, jp drain was placed on top of this 7-french and secured with 3-0 nylon and subcutaneous tissue was approximated with 3-0 monocryl.Skin was approximated with 4-0 monocryl.¿ a pathology report dated 3/29/2012 regarding a specimen collected 3/28/2012 states: ¿seroma, abdomen.¿ ¿gross description: received in formalin as ¿soft tissue of the abdomen, herniorrhaphy¿ is a saclike structure of tan connective tissue measuring 6.0 x 4.7 x 2.5 cm, weighing 32 g.The specimen is¿serially thin-sectioned in a bread loaf-type fashion revealing multiple areas of hemorrhagic foci as well as a hemorrhagic cyst measuring up to 2.5 cm in greatest dimension.¿ ¿permanent sections demonstrate a fibrotic hernia sac with seroma formation without evidence of ectopic tissue rest or neoplastic process.¿ ¿final diagnosis: ventral peritoneum, herniorrhaphy ¿ hernia sac with seroma.No evidence of ectopic tissue rest or neoplasm.¿ records dated 4/4/2012 state the patient was seen ¿for postop check following excision of a seroma with drainage.Jp drain is diminished in output and is removed.Incision is clean, dry and healing nicely.¿ records dated 1/9/2013 state the patient was seen for ¿dizziness and feeling sluggish since last pm.Also [complains of] vomiting today.¿ ct records state: ¿there has been interval repair of a ventral abdominal wall hernia, with multiple clips and mesh in place.Small bowel is not dilated.Colon has no severe diverticulosis, obvious wall thickening or obstruction.There has been an apparent appendectomy.Uterus and adnexa are unremarkable.There has been previous lower lumbar surgery and spinal stabilization.Impression: interval repeat ventral hernia repair.Prior cholecystectomy, appendectomy and lumbar surgery.¿ records dated 5/12/15 indicate patient is an insulin diabetic.Records dated 5/12/2015 indicate: ¿this is a 64-year-old white female with a history of multiple abdominal surgeries, who presents to the emergency department with a 3-day history of nausea, vomiting, and abdominal pain.¿ abdominal ct records state: ¿multiple surgical clips within the right pelvis.No free intraperitoneal air or fluid.Limited evaluation of the gi tract without enteric contrast.Mild diverticulosis of the left colon without inflammatory changes.Redemonstrated postoperative changes from ventral hernia repair with mesh.Small ventral hernia inferior and lateral to the mesh containing small loops of nondistended small bowel.Mild to moderate inflammatory stranding of the adjacent small bowel and soft tissue to the ventral hernia.Appendix not clearly identified but no pericecal inflammatory changes.¿ ¿impression: 1.Status post ventral hernia repair with adjacent herniation of small bowel and inflammatory changes.Correlate for incarceration.2.Hepatosplenomegaly.¿ operative records dated 5/12/2015 state the patient underwent ¿1.Laparoscopy with lysis of adhesions and subsequent conversion to exploratory laparotomy.2.Small bowel resection.3.Removal of infected mesh.4.Repair of colon and small bowel.5.Partial colectomy.6.Repair of incarcerated recurrent incisional hernia.¿ postoperative diagnosis states: ¿1.Recurrent incarcerated incisional hernia with bowel obstruction.2.Infected mesh.3.Necrotic small bowel.¿ the 5/12/2015 operative report states: ¿inspection revealed adhesions to the anterior abdominal wall.A 5 mm trocar was placed in the left upper quadrant laterally and dissection was carried out to free adhesions going to the anterior abdominal wall.While this was fairly easy to do laterally, it became more inflamed centrally and was not dissecting easily, and a decision was made to make an incision over the area just above the umbilicus where the ct scan suggested a hernia.Incision was made here, and no hernia was encountered.Dissection was carried down to the mesh.There was a hernia inferiorly.The skin was incised downward to expose this area.This hernia was actually just below where the mesh had been placed with omentum and a knuckle of small bowel present.This was reduced.The bowel at this area looked viable, and dissection was carried out to further define the anatomy and, in so doing, purulent fluid was expressed from the area underneath the mesh.¿ the 5/12/2015 operative report continues: ¿the incision was extended upward, incising the mesh and it became apparent that this was a component piece of mesh.The gore-tex was fairly thin, and this was removed.Exudate was present.Swab was taken for culture and sensitivity.Freeing this up, there was a rind on the small bowel immediately below this and very dense adhesions.This was very difficult to free up, and this was accomplished with blunt and sharp tedious dissection.With the small bowel dissected up, there was an area that was torn believed to be from bowel necrosis and this segment of bowel that was adherent was freed up and subsequently felt that it would need to be resected as there were several enterotomies from what appeared to be necrosis of the bowel.The bowel was freed up from the ligament of treitz to the ileocecal valve and the segment that was involved was approximately a foot in length.This was transected with the gia stapling device.The mesentery taken down with clamps, cut and tied with 2-0 and 3-0 silk ties.The staple lines were oversewn with 3-0 silk suture, and a side-to-side anastomosis was performed in 2 layers with 3-0 silk lembert sutures on the outer layer and 3-0 vicryl running suture on the inner layer.The mesentery was reapproximated with 3-0 chromic and with this done, the attention was turned back to the hernia and the mesh.¿ the 5/12/2015 operative report states: ¿the gore-tex portion of the mesh was resected, removing sutures and tacks that had been present.With this done, it was apparent that the colon was adherent to the mesh, part of the right colon as well as transverse colon.This was taken down via sharp dissection.A serosal defect was present on the right colon.This was repaired with 3-0 silk running suture.There was also serosal tear to the small bowel that had been noticed, and this was repaired with 3-0 silk sutures.The transverse colon was densely adherent ta mesh, and this appeared to be a different sort of mesh.This could not be separated from the colon and subsequently was reseated from the abdominal wall.With this done, the colon was then brought down and the mesh was able to be d1ssected, removing a portion of the colon wall.With this, the injured colon was reseated and closed in 2 layers with 3-0 silk lembert sutures on the outer layer and 3-0 vicryl on the inner layer.With this complete, the abdominal cavity was copiously irrigated.No other pathology was demonstrated.The fascia was closed with #1 prolene running continuous suture repairing the hernia inferiorly and reapproximating the mesh superiorly.With this done, subcutaneous tissues irrigated and hemostasis achieved.Skin was closed with 4-0 monocryl.¿ the records indicate abdominal cultures were obtained.There are no records detailing the implant of a ¿gore-tex¿ mesh and no product identification records for the alleged ¿gore-tex¿mesh.Pathology records dated 5/15/2015 regarding a ¿small bowel¿ specimen collected 5/12/2015 states: ¿clinical history: incarcerated incisional hernia.Tissue: small intestine, nos.Final diagnosis: small bowel from area of incarcerated incisional hernia {resection}: fibrous adhesions and acute inflammation within serosa.¿ ¿gross description: specimen labeled "small bowel'', consists of a segment of what appears to be small bowel, measuring approximately 66 cm.In length.The segment of small bowel has multiple areas of adhesions and is covered in tan gray exudate.There is one area where the loops of small bowel are adhesed together.¿ ¿microscopic description: sections of the small bowel reveal some fibrosis at the serosal surface.There are some polymorhonuclear leukocytes within the serosa.Sections of the exudate reveals similar acute inflammation within the serosa.¿ the pathology report does not indicate an explanted mesh was received and reviewed for analysis.Discharge records dated 5/18/2015 state: ¿the patient is a pleasant, 64-year-old caucasian female with a history of multiple abdominal surgeries who presented to the emergency department with a 3-day history of nausea, vomiting, and abdominal pain.Her ct scan revealed a small bowel incarceration into her ventral hernia, this inferior to the mesh.She was admitted for abdominal pain and incarcerated hernia.Dr.Sutherland was consulted as he had done her previous operations.¿ ¿dr.Sutherland performed a laparoscopic procedure that showed lysis of adhesions in this ventral hernia, removal of infected mesh and partial colectomy repair and incarcerated hernia with incisional hernia repair.The procedure went well at post surgery.She had bowel movements the following day.¿ microbiology report dated 5/19/2015 regarding cultures received 5/12/2015 indicate multiple organisms were identified, including escherichia coli, escherichia coli #2, streptococcus species, enterococcus faecalis, and enterococcus faecalis #2.Records dated 6/10/2015 state the patient was seen ¿for re-evaluation of her wound.She is doing well.Abdomen is soft, slight bit of drainage and a slight bit of induration.This seems less.Her culture came back mrsa.This is sensitive to cleocin, rifampin, tetracycline and vancomycin.It is not sensitive to the bactrim she is on.Her antibiotics were changed.She is to continue wound care.¿ records dated 7/1/2015 state the patient ¿¿is doing well.Incision is clean, dry, and healing nicely.No erythema, minimal induration.¿ 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: ¿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: 4316: appropriate term/code not available for â¿¿withdrawn complaintâ¿¿.Previous patient codes (1695, 1930) were reported based on the original complaint and are no longer applicable per goreâ¿¿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.Based upon goreâ¿¿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.The following information was determined from the medical records.Medical records: the known medical records span october 19, 2000 through july 1, 2015 and not all records received in this time span are relevant to the alleged gore-texâ® soft tissue patch.Medical records from october 28, 2000 through august 11, 2003, and from may 23, 2007 through august 9, 2010 were not provided.Medical records including an operative report for the herniorrhaphy and alleged implant of a gore device performed on (b)(6) 2003 were not provided.There was no product identification for the alleged implanted gore device.Patient information: medical history: (b)(6) 2003: incarcerated incisional hernia.Morbid obesity.(b)(6) 2011: 255 lbs.Diabetes mellitus.(b)(6) 2015: insulin dependent.Prior surgical procedures: unknown date: appendectomy.(b)(6) 2000: repair of an incarcerated umbilical hernia and laparoscopic cholecystectomy.Implant preoperative complaints: (b)(6) 2003: abdominal ct performed for history of vomiting and abdominal pain.¿¿no free air or free fluid is seen within the abdomen.Note is made of a ventral hernia at the level of the umbilicus which contains small bowel and there is dilatation of proximal small bowel leading into this with normal decompressed small bowel extending out.Findings are consistent with an obstructing umbilical hernia.No adenopathy is seen in the abdomen or pelvis.¿¿ â¿¿impression: umbilical ventral hernia producing obstruction of proximal small bowel as described above.No associated free air or pneumatosis is noted.¿¿.(b)(6) 2003: history and physical: â¿¿plan: repair with meshâ¿¿.Implant procedure: herniorrhaphy.Implant: unknown mesh.Implant date: (b)(6) 2003 (hospitalization (b)(6) 2003).No operative report provided.(b)(6) 2003: pathology: â¿¿incarcerated incisional herniaâ¿¿ â¿¿final diagnosis: periumbilical peritoneus [sic], herniorrhaphy â¿¿ acute and chronic inflammation with granulation tissue formation consistent with incarcerated hernia.¿¿.(b)(6) 2003: discharge summary: â¿¿presented to the emergency room with abdominal pain and found to have incarcerated incisional hernia.Had been having nausea and vomiting for a few days and taken to the or and found to have incarcerated hernia with gangrenous bowel.Bowel resection was performed.Hernia was repaired.Postoperatively, she has done well.¿¿.Relevant medical information: (b)(6) 2007: emergency room visit with abdominal pain, nausea, vomiting.Found to have a hernia and radiographic signs of a bowel obstruction.Past surgical history: includes a previous hernia repair and a history of phlebitis.She has had hernia repair with mesh.(b)(6) 2007: operative report: â¿¿1) repair of recurrent incarcerated incisional hernia x two with mesh.2) omentectomy.3) repair of enterotomy.¿¿ implant: prolene mesh.¿¿entrance gained through the previous incision around the umbilicus where the hernia was present protruding off to the right side.With the skin incised electrocautery was used for dissection down through subcutaneous tissue and the hernia sac was identified and opened.Incarcerated omentum and bowel was present.This was freed up via blunt and sharp dissection using electrocautery for hemostasis.A serosal tear was noted in the bowel and this was repaired with 3-0 silk lembert sutures.Some devitalized omentum was present and this was excised using electrocautery.With this done the hernia sac was excised to define the fascial edges.Mesh was noted superiorly as well as some inferiorly.The fascia was noted laterally on both sides.The small bowel was inspected and appeared fairly normal without evidence of an obstructive process.Dissection was carried out further underneath the mesh and another hernia was present in the epigastric area.The incision was extended superiorly to define this area and a hernia was present.The hernia sac was excised and incarcerated bowel was reduced.With the fascial edges defined it was felt that these both could be repaired with mesh.There was mesh present in the lower hernia that was attached to fascia and mesh inferiorly using #1 ethibond interrupted sutures thereby repairing this hernia.Prolene mesh was placed in the superior aspect and sewn to the fascial edges circumferentially with #1 prolene running suture.¿¿.(b)(6) 2007: pathology: â¿¿abdominal wall (resection): hernia sac.¿¿.(b)(6) 2010: ct abdomen: â¿¿multiple metallic clips are associated with mesh repair of a ventral hernia.A 4 cm ventral hernia lies just superior to the mesh.This contains a normal appearing segment of transverse colon.Surgical clips are present secondary to a cholecystectomy.Sections through the pelvis reveals surgical clips on the right.¿¿ â¿¿impression: ventral hernia.¿¿.(b)(6) 2012: operative report: â¿¿1.Robotic-assisted laparoscopic repair of the incarcerated recurrent incisional hernia.2.Laparoscopic repair of ventral hernia.3.Utilization of mesh for repair of recurrent incarcerated hernia.¿¿ implant: bard mesh x 2.¿¿the patient had a hernia in the epigastric area, somewhat to the left.It was decided to enter on the left side of the abdomen, and a 12 visiport was used to enter the left flank approximately 15 cm to 20 cm from the midline.With this, pneumoperitoneum was established, and adhesions were noted to the lower abdominal area.An 8 mm trocar was placed in the left upper quadrant and sharp dissection was utilized laparoscopically to take down adhesions in the left lower quadrant to the point where the third trocar could be placed.An 8 mm trocar was placed in the left lower quadrant.With this, the patient cart was brought to the patient and docked with the trocars.Instrumentation was inserted with the camera using a 30 degree upscope and bipolar grasper and hot shears.Dissection was carried out to free the incarcerated omentum and bowel from the hernia.This was done without too much difficulty.There was concern for another hernia inferiorly, such that adhesions were taken down inferiorly to the anterior abdominal wall.Here, it appeared that she had some mesh placed that may have been biosynthetic.¿¿ â¿¿she had another piece of marlex mesh placed in the upper abdomen that was visualized and still intact but served as a border to the hernia.The adhesions were taken down and another ventral hernia was noted.This appeared to be small enough to be repaired with suture.With all the adhesions taken down, the 3 x 6 piece of mesh that had been placed at the beginning of the procedure on getting the trocars in place, and it became apparent that this was not big enough for the hernia, such that i scrubbed back in and removed that mesh and placed a 6 x 6 piece of mesh intra-abdominally with 5 #1 prolene sutures and a 3-0 silk suture in the abdominal cavity.I then returned to surgeon's console and placed the mesh, securing this circumferentially with #1 prolene interrupted sutures.With this done, a #1 prolene suture was placed in the ventral hernia inferiorly using figure-of-eight suture.With this secured, i scrubbed back in and used the protacker to secure the mesh additionally outside the hernia defect and in between the sutures.¿¿ (b)(6) 2012: fullness at her previous hernia site.No signs of infection.Incision is clean, dry and healing nicely.Suspect seroma or recurrent hernia.(b)(6) 2012: ct abdomen.¿¿probable benign postop seroma with no wall thickening.¿¿ (b)(6) 2012: percutaneous aspiration 80 cc of serosanguinous fluid.(b)(6) 2012: recurrent seroma.Needle aspiration of 45 cc serosanguinous fluid.(b)(6) 2012: excision of seroma and hernia sac.¿¿a transverse incision was made over this ___ [sic] resection out through subcutaneous tissue and the sac was read circumferentially down to fascial edge.It was opened and contained serous fluid as well as debris that appeared to be consistent with___ [sic] material as well as old thrombus with the fat drained.It was taken down to near fascial edge and the mesh seem to be intact in the repair with no evidence of recurrent herniation with the sac excised.¿¿.(b)(6) 2012: pathology: final diagnosis: ventral peritoneum, herniorrhaphy â¿¿hernia sac with seroma.(b)(6) 2013: abdominal ct: interval repeat ventral hernia repair.Explant preoperative complaints: (b)(6) 2015: â¿¿this is a 64-year-old white female with a history of multiple abdominal surgeries, who presents to the emergency department with a 3-day history of nausea, vomiting, and abdominal pain.¿¿ abdominal ct records state: â¿¿multiple surgical clips within the right pelvis.No free intraperitoneal air or fluid.Limited evaluation of the gi tract without enteric contrast.Mild diverticulosis of the left colon without inflammatory changes.Redemonstrated postoperative changes from ventral hernia repair with mesh.Small ventral hernia inferior and lateral to the mesh containing small loops of nondistended small bowel.Mild to moderate inflammatory stranding of the adjacent small bowel and soft tissue to the ventral hernia.Appendix not clearly identified but no pericecal inflammatory changes.¿¿ impression: â¿¿1.Status post ventral hernia repair with adjacent herniation of small bowel and inflammatory changes.Correlate for incarceration.2.Hepatosplenomegaly.¿¿.Explant procedure: 1.Laparoscopy with lysis of adhesions and subsequent conversion to exploratory laparotomy.2.Small bowel resection.3.Removal of infected mesh.4.Repair of colon and small bowel.5.Partial colectomy.6.Repair of incarcerated recurrent incisional hernia.Explant date: (b)(6) 2015 (hospitalization (b)(6) 2015).¿¿inspection revealed adhesions to the anterior abdominal wall.A 5 mm trocar was placed in the left upper quadrant laterally and dissection was carried out to free adhesions going to the anterior abdominal wall.While this was fairly easy to do laterally, it became more inflamed centrally and was not dissecting easily, and a decision was made to make an incision over the area just above the umbilicus where the ct scan suggested a hernia.Incision was made here, and no hernia was encountered.Dissection was carried down to the mesh.There was a hernia inferiorly.The skin was incised downward to expose this area.This hernia was actually just below where the mesh had been placed with omentum and a knuckle of small bowel present.This was reduced.The bowel at this area looked viable, and dissection was carried out to further define the anatomy and, in so doing, purulent fluid was expressed from the area underneath the mesh.The incision was extended upward, incising the mesh and it became apparent that this was a componen t [sic] piece of mesh.The gore-tex was fairly thin, and this was removed.Exudate was present.Swab was taken for culture and sensitivity.Freeing this up, there was a rind on the small bowel immediately below this and very dense adhesions.This was very difficult to free up, and this was accomplished with blunt and sharp tedious dissection.With the small bowel dissected up, there was an area that was torn believed to be from bowel necrosis and this segment of bowel that was adherent was freed up and subsequently felt that it would need to be resected as there were several enterotomies from what appeared to be necrosis of the bowel.The bowel was freed up from the ligament of treitz to the ileocecal valve and the segment that was involved was approximately a foot in length.This was transected with the gia stapling device.The mesentery taken down with clamps, cut and tied with 2-0 and 3-0 silk ties.The staple lines were oversewn with 3-0 silk suture, and a side-to-side anastomosis was performed in 2 layers with 3-0 silk lembert sutures on the outer layer and 3-0 vicryl running suture on the inner layer.The mesentery was reapproximated with 3-0 chromic and with this done, the attention was turned back to the hernia and the mesh.The gore-tex portion of the mesh was resected, removing sutures and tacks that had been present.With this done, it was apparent that the colon was adherent to the mesh, part of the right colon as well as transverse colon.This was taken down via sharp dissection.A serosal defect was present on the right colon.This was repaired with 3-0 silk running suture.There was also serosal tear to the small bowel that had been noticed, and this was repaired with 3-0 silk sutures.The transverse colon was densely adherent ta mesh, and this appeared to be a different sort of mesh.This could not be separated from the colon and subsequently was reseated from the abdominal wall.With this done, the colon was then brought down and the mesh was able to be dissected, removing a portion of the colon wall.With this, the injured colon was reseated and closed in 2 layers with 3-0 silk lembert sutures on the outer layer and 3-0 vicryl on the inner layer.With this complete, the abdominal cavity was copiously irrigated.No other pathology was demonstrated.The fascia was closed with #1 prolene running continuous suture repairing the hernia inferiorly and reapproximating the mesh superiorly.With this done, subcutaneous tissues irrigated and hemostasis achieved.Skin was closed with 4-0 monocryl.¿¿.(b)(6) 2015: pathology: â¿¿tissue: small intestine, nos.Final diagnosis: small bowel from area of incarcerated incisional hernia {resection}: fibrous adhesions and acute inflammation within serosa.¿¿ â¿¿gross description: specimen labeled "small bowel'', consists of a segment of what appears to be small bowel, measuring approximately 66 cm.In length.The segment of small bowel has multiple areas of adhesions and is covered in tan gray exudate.There is one area where the loops of small bowel are adhesed together.¿¿ â¿¿microscopic description: sections of the small bowel reveal some fibrosis at the serosal surface.There are some polymorphonuclear leukocytes within the serosa.Sections of the exudate reveals similar acute inflammation within the serosa.¿¿ the pathology report does not indicate an explanted mesh was received and reviewed for analysis.(b)(6) 2015: discharge summary: â¿¿dr.(b)(6) performed a laparoscopic procedure that showed lysis of adhesions in this ventral hernia, removal of infected mesh and partial colectomy repair and incarcerated hernia with incisional hernia repair.The procedure went well at post surgery.¿¿.(b)(6) 2015: microbiology report: â¿¿multiple organisms were identified, including escherichia coli, escherichia coli #2, streptococcus species, enterococcus faecalis, and enterococcus faecalis #2.¿¿.Relevant medical information: (b)(6) 2015: â¿¿re-evaluation of her wound.She is doing well.Abdomen is soft, slight bit of drainage and a slight bit of induration.This seems less.Her culture came back mrsa.This is sensitive to cleocin, rifampin, tetracycline and vancomycin.It is not sensitive to the bactrim she is on.Her antibiotics were changed.She is to continue wound care.¿¿.(b)(6) 2015: doing well.¿¿incision is clean, dry, and healing nicely.No erythema, minimal induration.¿¿.Conclusion: the alleged â¿¿gore-texâ¿¿ mesh is being captured as gore-texâ® soft tissue patch for product surveillance purposes.It should be noted that the gore-texâ® soft tissue patch instructions for use include warnings and addresses the following adverse reactions among others: â¿¿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-texâ® 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 warn: â¿¿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: â¿¿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 manufacturerâ¿¿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 patientâ¿¿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, product identification information was not provided for this device and thus it could not be confirmed to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.In an abundance of caution for product surveillance tracking and trending purposes only, this event has been analyzed, coded and reported as necessary assuming it is a gore hernia device.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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