|
Model Number 1DLMC07 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Unspecified Infection (1930); Seroma (2069)
|
Event Date 05/20/2014 |
Event Type
Injury
|
Manufacturer Narrative
|
It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® 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.".
|
|
Event Description
|
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2002 whereby two gore® dualmesh® biomaterial devices were implanted, and additionally on (b)(6) 2005 whereby another gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2014 an additional procedure occurred whereby a gore device was partially explanted.It was reported the patient alleges the following injuries: hernia recurrence, non adherence, infection, lack of incorporation, partial explant.Additional event specific information was not provided.
|
|
Manufacturer Narrative
|
Correcting date received by manufacturer for the initial mdr: the information needed to determine reportability was received on (b)(6)2021, not on (b)(6)2021.
|
|
Manufacturer Narrative
|
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: implant procedure #1: incisional hernia repair x2.Implant: gore® dualmesh® biomaterial [1dlmc07/01295434] implant date #1: (b)(6) 2002 (hospitalization unknown) (b)(6) 2002: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: multiple incisional hernias of umbilicus and previous kocher incision.Postoperative diagnosis: multiple incisional hernias of umbilicus and previous kocher incision.Resident surgeon: (b)(6) md.Anesthetic: general endotracheal.First assistant: (b)(6) md.Indications for surgery: mrs.(b)(6) is a 46-year-old female with a history of an open gallbladder, although previously attempted laparoscopically and she presented to us with incisional hernias of both the umbilicus and the kocher incision.She is brought to the operating room at this time for elective repair.Procedure in detail: ¿after proper identification in the outpatient surgery unit, mrs.(b)(6) was brought to the operating room, placed in the supine position, and satisfactory general endotracheal anesthesia was induced.After such she was prepped and draped of the entire abdomen in the usual sterile fashion.Attention was first directed to the umbilicus where an incision was made over her previous umbilical incision and a combination of sharp, blunt, and bovie electrocautery dissection was used to dissect down.The fascial defect was encountered and care was taken to dissect clean all edges of the fascia, both above the fascia and below the fascia.Once this was done and the fascia was felt to be completely clean with no bowel in the area of the defect, a piece of gore-tex dual mesh was fashioned and using # ethibond in a u stitch fashion, the patch was sewn in place underneath the fascia.Care was taken to insure that the correct side of the mesh was facing the bowel.Once this was sewn in place and the repair was felt to be adequate, attention was turned to the kocher incision where her previous incision was opened.A combination of blunt, bovie electrocautery, and sharp metzenbaum dissection was again used to dissect the overlying tissues and underlying tissues off the fascia from both above and below.Once thus had been done, it was verified there were no adhesions to the fascia from either above or below.A second piece of gore-tex dual mesh was cut and fashioned, and again sutured in place using #1 ethibond in a u stitch fashion.The sutures were tied and once this had been completed, the hernia was felt to be adequately repaired.Both the umbilical and kocher incisions were then closed in two layer running vicryl fashion to protect the mesh from infection and the skin was closed with staples.The patient tolerated the procedure well.There were no complications.She was awakened from general endotracheal anesthesia and transferred to the recovery room in satisfactory condition.¿ complications: none.Estimated blood loss: less than 50 cc.Specimen: none.(b)(6) 2002: university hospitals and clinics.Operating room record.Procedure: incisional hernia repair x2.Implant sticker.Gore-tex dualmesh biomaterial.Item#: 1dlmc07.Lot#: 01295434.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc07/ 01295434) was implanted during the procedure.Explant procedure #1: exploratory laparotomy through a previous kocher incision.Repair of small bowel hernia.Explant date #1: (b)(6) 2004 (hospitalization unknown).(b)(6) 2004: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: small bowel obstruction.Postoperative diagnosis: small bowel obstruction.Resident surgeon: laura vick, md.Anesthetist: tapati basu ray, md.Anesthetic: general endotracheal anesthesia.Indications for procedure: the patient is a 48-year-old black female who presented to the emergency room with a several day history of nausea, vomiting, and abdominal pain.The patient felt to have a small bowel obstruction and part of her workup included a ct scan of the abdomen and pelvis which showed a loop of small bowel incarcerated in a prior right upper quadrant incision.At this point, after a day on the general surgery ward without any improvement, we felt the patient needed to be taken to the operating room and have an incisional hernia repaired and small bowel obstruction unobstructed.The risks and benefits of the operation were explained to the patient and all questions answered and the patient agreed to proceed with the operation.¿the patient was taken to the operating room and placed supine on the operating table and general endotracheal anesthesia was obtained uneventfully.The patient¿s abdomen was then prepped and draped in the usual sterile fashion.Using a #11 blade, the previous subcostal kocher incision was opened.This incision was carried down to avoid the fascia using electrocautery.At this point we encountered multiple swiss cheese defects in the fascia which included one area to the right lateral side that included a small knuckle of bowel.We also encountered the patient¿s prior mesh repair with also having a defect to the medial aspect of this mesh.At this point, the peritoneal cavity was opened and we encountered a large amount of ascites.This fluid was suctioned off and sent for cytology.At this point the entire length of the facial incision was opened and the prior mesh was excised.All the small bowel were everted and inspected.It was noted that at the area of incarceration, the patient had minimal bruising of the small bowel but no ischemic changes.The small bowel was ran.It was noted that the patient did have prior small bowel anastomosis most likely consistent with choledochojejunostomy with roux limb.The patient was found to have several small bands of adhesions within the rest of the small bowel but no obvious bands kinking off any other areas of the small bowel.The patient also noted upon inspection of the small bowel to have approximately 7 mm white lesion in the mid jejunal area of the small bowel.This was resected and sent off for pathology.A 2-0 vicryl horizontal mattress suture was used to repair the serosal defect from the specimen site.After the small bowel was ran, the small bowel was replaced into the abdominal cavity and the remaining adhesions to the anterior abdominal wall around the previous incision were taken down using a combination of metzenbaum and electrocautery.Once we felt like we had adequately freed up the fascia, a 13 x 22 piece of surgisis gold mesh was placed into the abdominal cavity, 1-0 pds was then used to attach this mesh to the underside of the peritoneal fascia placing 1 initial suture in the 12, 3, 6, and 9 o¿clock positions.These sutures were than ran toward each other and tied off to the adjacent ends.The wound was then irrigated.The scarpa¿s fascia was then opposed with interrupted 3-0 vicryl and the skin closed with 4-0 monocryl in a running fashion.The patient¿s wound was then dressed and the patient was reversed from general anesthesia uneventfully.The patient was taken to the recovery room in stable condition.Dr.Poole was present for the key portions of the procedure excluding initial incision and closure of the skin.All counts were correct.¿ specimens: peritoneal fluid for cytology.Old mesh.Mid jejunal small bowel lesion.(b)(6) 2004: (b)(6) medical center.Implant sticker.Surgisis gold hernia repair graft.Relevant medical information: (b)(6) 2005: (b)(6) medical center.(b)(6) md.Operative note.Preoperative diagnosis: recurrent incisional hernia.Postoperative diagnosis: recurrent incisional hernia.Operation: repair of incisional hernia with surgisis mesh.Resident surgeon: (b)(6) md.Anesthetist: (b)(6) , md.Nurse anesthetist: (b)(6) crna.Anesthetic: general endotracheal.Indications for surgery: the patient is a 49-year-old black female who had undergone repair of an incisional hernia back in (b)(6) 2004, with surgisis mesh.The patient had had a prior laparoscopic converted to open cholecystectomy with a bile duct injury.Postoperatively the patient had developed a wound infection with a possible colonic fistula; however, this closed spontaneously.The patient now presents to the surgery clinic with a large defect and persistent pain, and desires to have the hernia repaired.Intraoperative findings: complete dissolution of the prior surgisis mesh with a moderate amount of intestinal adhesions to the anterior abdominal wall.Procedure in detail: ¿therefore the patient was taken to the operating room, general endotracheal anesthesia was performed, and a foley catheter was placed.The patient¿s abdomen was prepped and draped in the normal sterile fashion for an abdominal procedure.The patient had a large scar from her right subcostal incision from the prior open cholecystectomy.The scar was excised in its entirety of the incision consisting of approximately 20 cm long and 2 cm wide in its largest dimension.Electrocautery was used to transect down through the subcutaneous tissue down to the fascial defect.In transecting down to the abdominal wall fascia it was noted that the surgisis had completely dissolved from the prior hernia repair in november of 2004.There were noted to be multiple adhesions of small bowel to the fascial edges.These adhesions were taken down using sharp dissection.Once all adhesions were freed from the fascia was cleared on the anterior aspect approximately 2 cm in a circumferential pattern to allow for adequate suturing of the mesh to the fascial edges.A large piece of surgisis mesh approximately 20 cm x 13 cm brought into the operating room field and it was noted that this mesh would be too small.Therefore an additional approximately 8 cm x 13 cm mesh was sutured end-to-end to the surgisis mesh to make a mesh size of approximately 30 x 13 cm.The surgisis mesh was then sutured to the abdominal fascia in a running fashion using 2-0 prolene.Care was taken to ensure there was no bowel injury when suturing the mesh to the fascia.Also it should be noted that the mesh was placed posterior to the fascial edges when sewn into place.Following securement of the surgisis mesh to the posterior aspect of the anterior wall fascia the area was thoroughly irrigated wit betadine solution.The subcutaneous tissue was reapproximated using multiple interrupted 2-0 vicryl sutures and the skin was reapproximated with a running 4-0 monocryl.Mastisol and steri-strips were then applied to the skin.It should also be noted prior to closure of the subcutaneous tissue and skin a blake drain was placed and brought out of the patient¿s right flank.The patient tolerated the entire procedure well and was transferred to the pacu in stable condition.The sponge, needle, and lap counts were correct at the end of the operation.¿ pathology: no specimens sent.Estimated blood loss: 200 cc.Intravenous fluids: 2,100 ml.Drains: one blake drain.Counts: the sponge, needle, and lap counts were correct.Complications: there were no complications.Note: dr.Poole directly participated in the entire operation.(b)(6) 2005: (b)(6) medical center.Implant sticker.Surgisis gold hernia repair graft x2.(b)(6) 2006: (b)(6) medical center.[signature illegible].Anesthesia record.Asa 2.Weight 239 lbs.Implant procedure #2: repair of incisional hernia with dual-mesh gauze.Implant: gore® dualmesh® biomaterial [1dlmc07/03854329, 20 x 30 cm] implant date #2: (b)(6) 2006 (hospitalization unknown) (b)(6) 2006: (b)(6) medical center.(b)(6) , md.Operative report.Preoperative diagnosis: large recurrent incisional hernia.Postoperative diagnosis: large recurrent incisional hernia.Anesthesia: general endotracheal.Anesthetist: (b)(6) md.Indications: the patient is a 50-year-old lady who has already had 3 prior incisional hernia repairs.Her original operation had been an open cholecystectomy and repair of a common duct injury following a laparoscopic cholecystectomy.She had her last repair about 2 years ago, but the hernia has recurred.She was seen earlier this year but did not want to have surgery done.She returned recently requesting that she have surgery because the hernia had gotten larger, and she was having discomfort.Description of procedure: ¿the patient was brought to the or and placed on the table in the supine position.After induction of general endotracheal anesthesia, a foley catheter was placed.Her abdomen was cleaned with alcohol and prepped with duraprep.Drapes were applied to create a sterile field.I opened her old transverse wound laterally.However, after opening the skin and the subcutaneous tissue, it became obvious that the entire repair had come apart.I therefore extended the incision from one end to the other, excising the old dermal scar.After opening the subcutaneous tissue, i was able to take down a number of adhesions of small bowel and colon on the undersurface of the skin wounds.The muscle had retracted inferiorly and superiorly on each end, leaving a very broad defect.After evaluating this, i decided it would be best to repair it with a large piece of mesh.I chose a dual mesh, a combination of gore-tex with marlex.A 20 x 30 cm piece of mesh was chosen.This was laid into position, and it was obvious that it would adequately close the defect.Once this was in place, i made sure that the small bowel and colon were out of the way by packing them away with a large blue towel.I then began placing multiple interrupted #1 prolene sutures, starting at the left apex, and then bringing these around on each side towards the right apex.As several of the sutures were placed, they were then tied.I was very careful to make sure that small bowel did not get caught into the closure and also made sure that mesh would be lying flat against the undersurface of the abdominal wall.After the repair was nearly intact, i was able to pull the towel out from the abdominal cavity.I now placed the remaining sutures; and after these were all placed, they were tied.Again, care was taken to prevent any injury to the underlying hollow viscera.I now made sure that the mesh was in good position; and once this was assured, i irrigated the wound copiously with saline.After making sure that i had good hemostasis, a 19-round blake drain was placed through a stab wound and secured to the skin with a 2-0 nylon.The subcutaneous scar was now closed with a 2-0 vicryl.It was widely irrigated with saline.I then closed the skin with staples followed by dressings of xeroform, four by fours, and abd pads.An abdominal binder was placed.The patient was then awakened and taken to the recovery room.She tolerated the operation without any complications and a blood loss of about 120 ml.¿ (b)(6) 2006: (b)(6) medical center.Implant sticker.Gore dualmesh® biomaterial.Ref catalogue number: 1dlmc07.Lot batch code: 03854329.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc07/ 03854329) was implanted during the procedure.Relevant medical information: (b)(6) 2006: (b)(6) medical center.(b)(6) radiology-upper gi.Indication: post prandial abdominal pain.Impression: unremarkable upper gi.(b)(6) 2006: (b)(6) medical center.[signature illegible].Anesthesia record.Weight 107 kg.Asa 3.(b)(6) 2006: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: abscess abdominal wall.Postoperative diagnosis: cellulitis of abdominal wall.Operation: incision, drainage, debridement and irrigation of abdominal wall.Anesthesia: general by lma.Anesthetist: (b)(6) md.Indications for procedure: mrs.(b)(6) is a 50-year-old lady who is almost 2 months status post repair of an abdominal wall hernia with a piece of dual mesh gauze.She was admitted about 2 to 3 weeks ago with a suspected infection, but the cultures were sterile.He wound had actually nearly healed but she came to the emergency room last night with an increased area if induration in the abdominal wall.Description of procedure: ¿mrs.(b)(6) was brought to the operating room and placed on the table in the supine position.Her abdomen was cleaned with betadine and prepped with betadine.Drapes were applied to create a sterile field.She had an area of induration and erythema in the mid portion of her abdominal wall over the transverse scar.This was very hard and fibrotic and although there was no fluctuance, i suspected that she had an abscess underneath the skin.I opened an area approximately 12 cm in length, using an ellipse to excise the old scar.Instead of having an abscess, i found only cellulitic changes without any evidence of purulence.I aspirated several areas with a needle surrounding this site, but was not able to get any purulent fluid back.I did use a larger needle and went more lateral and aspirated a fairly large seroma from underneath the previously placed mesh.I received a total of about 400 ml of the stained serous fluid that did not have any evidence of infection by external appearance.It was submitted for culture, as was fluid from within the surgically created wound.I then made sure that i had good hemostasis.When this was assured, i gently packed the wound with some 4 x 4s soaked in dilute betadine.4 x 4s were placed over this, and as well as an abd pad.It was secured to the skin.The patient was then awakened and taken to the recovery room.She tolerated the operation without any complications and a blood loss of 20-30 ml.¿ (b)(6) 2007: (b)(6) medical center.(b)(6) md.Emergency room visit.Present with generalized abdominal pain.Onset of symptoms 2 days ago, came on gradually and progressively got worse.Located in the right upper quadrant.Surgical history of tubal ligation.Negative for alcohol and tobacco use.Exam: abdomen protuberant.Mild tenderness to palpation in the ruq.There is no guarding.Rebound tenderness is absent.Cystic lesion in incision (scar) with minimal cellulitis surrounding the area.Impression: suture line abscess.Patient discharged home.Suture line abscess drained in emergency department by dr.Poole.(b)(6) 2007: (b)(6) medical center.[signature illegible].Progress notes.Prior hernia repair and past fat necrosis (persistent sterile cultures).Presented with 3 days swelling, pain [illegible] midline of transverse wound.Has 2.5 x 2 cm area of induration, fluctuance with in old surgical wound.Impression: infection vs fat necrosis.Plan: incision and drainage.Betadine prep, sterile field 1% lidocaine with epinephrine anesthesia.Short elliptical wound, purulent material cultured.Dry dressing.(b)(6) 2010: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: this is a 54-year-old, g4, p4 african american female with uterine fibroids and pelvic pain.Postoperative diagnosis: this is a 54-year-old, g4, p4 african american female with uterine fibroids and pelvic pain.Operation: total abdominal hysterectomy, bilateral salpingo-oophorectomy.Findings: a 14-week fibroid uterus.Bilateral normal tubes and ovaries.Explant procedure #2: removal of intraabdominal mesh.Explant date #2: (b)(6) 2014 (hospitalization unknown) (b)(6) 2014: (b)(6) medical center.(b)(6) md.Operative report.Preoperative diagnosis: recurrent seroma from multiple ventral hernia repairs with mesh.Postoperative diagnosis: same.Surgical resident: (b)(6) , md; (b)(6) md.Anesthesia staff: anesthesiologist: (b)(6) md.Crna: (b)(6).Ebl: minimal.Complications: none.Findings: large chronic ruq subcutaneous fluid collection, murky yellow fluid suctioned/cultured, large unincorporated goretex mesh, intrabdominal fluid collection.Indications for procedure: mrs.(b)(6) is a 58 y/o female with multiple prior attempts at ventral hernia repair over several years.One of which included a large piece of goretex mesh.She had a recurrent fluid collection associated with this mesh that has required continued percutaneous drainage.She has grown weary of continued percutaneous intervention.The risks and benefits of open wound exploration and mesh removal were relayed to her and she requested to proceed with intervention.Procedure in detail: ¿patient was brought to operating room laid supine.Orotracheal intubation was performed.Foley catheter was placed.The abdomen was sterilely prepped and draped.Time-out was taken led by dr.Helling and everyone was in agreement with procedure to be performed.Preoperative iv cefoxitin was given as prophylaxis.The previous transverse incision was opened sharply.The chronic rind around fluid collection was encountered and dissected free from subcutaneous tissue.The collection was entered sharply and murky yellow fluid was cultured and then suctioned.The capsule itself was quite thick and fibrous.Goretex mesh was visualized in the depths of the wound.Most of the rind around chronic fluid collection was excised, leaving enough for later closure.The goretex mesh was elevated and entered sharply, similar fluid was suctioned from below the mesh.The mesh was poorly incorporated centrally.Mesh was removed from surrounding abdominal wall tissue with blunt and sharp dissection, the previous prolene sutures were cut.This was a rather difficult endeavor as the mesh, around the edges, was embedded in native abdominal wall and peritoneum.Intraabdominal adhesions were cleared sharply.There were probably other smaller pieces of difficult well encorporated [sic] mesh that were left adherent to lateral abdominal wall.Once the goretex mesh was removed in its entirety, the fibrous capsule was reapproximated to effect a repair of the now created ventral hernia.The capsule (constituting the abdominal wall) was closed with 0-maxon figure of eight suture.No drain was felt indicated.The deep dermal layer was approximated with 3-0 vicryl suture.The skin was closed with 4-0 monocryl and dermabond.Patient was extubated and returned to pacu in stable condition.I, dr.Helling, was present and scrubbed for key portions of this operation including identification of the seroma, drainage of fluid, removal of mesh, and reconstruction of the abdominal wall.I was immediately available to return if needed.I have reviewed and edited this operative dictation.¿ 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 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.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 results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
|
Manufacturer Narrative
|
H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.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
|
|
|