|
|
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Erosion (1750); Unspecified Infection (1930); Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 02/10/2000 |
|
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 open diaphragmatic hernia repair on (b)(6) 1998 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2000, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: dense adhesions, surgery to remove mesh, hernia recurrence, infection, erosion of the gore-tex graft through the ge junction, abscess, chronic inflammation, and severe and chronic pain/discomfort.Additional event specific information was not provided.
|
| |
|
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: relevant medical information: ¿ [ni ¿ not indicated] implant procedure: repair of diaphragmatic hernia with gore-tex patch through a laparotomy and thoracostomy x 2.Implant: gore® dualmesh® biomaterial [1dlm08/ p12197-077] implant date: (b)(6), 1998 (hospitalization ni) ¿ (b)(6) 1998: (b)(6) hospitals and clinics.(b)(6), md.Operative report.Clinical diagnosis: diaphragmatic hernia.Postoperative diagnosis: same.Preparation: iodine, pvp, and betadine.Indications: ¿this 26-year-old man is status post left nissen in (b)(6) 1998 which fell apart and he developed a hernia.He was returned to the operating room for repair of the hernia on 9/25/98.A few days later he developed acute abdominal pain and evidence of a hernia by x-rays.He was taken to the operating room for repair.¿ procedure: ¿the patient was intubated with a double lumen endotracheal tube, placed in the right lateral decubitus position and a posterolateral left thoracotomy was made.There seemed to be a huge hernia in the left chest.The inferior pulmonary ligament was taken down.The edges of the diaphragm were slowly developed and the right chest was entered.At the end of the procedure a right chest tube was placed.It seemed to be very difficult the level of the nissen because of severe scar tissue, but it was partially taken down and it remained in a toupet position.We were not able to free up space in the belly because of scar formation so we closed the thoracotomy in a routine fashion with a chest tube in place.A right midline laparotomy was made with the patient in supine position.This was slowly performed due to difficulties with the scar formation.The lobe of the liver was freed from the abdominal part of the stomach and the spleen was retracted to the left.It remained intact.From this position we were not able to identify the edges of the diaphragm so we closed the laparotomy with interrupted prolene sutures in a routine fashion.The patient was turned to the right lateral decubitus position.The previous left posterolateral thoracotomy was opened and easily the stomach was positioned in a toupet fashion with the esophagus attached below the diaphragm.A gore-tex patch was sutured in place with interrupted prolene circumferentially.The esophagus was placed posteriorly and then secured to the neodiaphragm with three interrupted 3-0 prolene and a finger was able to pass around it.Estimated blood loss was approximately 1000 cc.Two chest tubes were placed and the left thoracotomy was closed in a routine fashion.The patient tolerated the procedure well without complications.Esophagogastrostomy was performed and will be dictated by dr.(b)(6).¿ ¿ (b)(6) 1998: (b)(6) hospitals and clinics.Implant sticker.Gore-tex dualmesh biomaterial.Item#: 1dlm08.Lot#: p12197-077.¿ the records confirm a gore® dualmesh® biomaterial [1dlm08/ p12197-077] was implanted during the procedure.Relevant medical information: ¿ (b)(6) 1998: (b)(6) hospitals and clinics.(b)(6), md.Operative report.Operation: upper endoscopy, esophagogastroduodenoscopy.Assistant surgeon: (b)(6).Clinical diagnosis: status post revision of previous nissen fundoplication with reapproximation of diaphragmatic hernia.Postoperative diagnosis: same with evidence of the ge junction being below the diaphragm.Preparation: iodine, pvp, and betadine.Indications: ¿this 26-year-old man recently underwent repeat attempts at a nissen fundoplication.He is status post two failed attempts at local institution and just underwent a thoracic and abdominal approach for repair of a diaphragmatic hernia.An upper endoscopy is warranted to determine the position of the ng tube and to ensure that the wrap is below the level of the diaphragm.¿ procedure: ¿the esophagogastroduodenoscope was passed into the oral cavity without difficulty.An olympus scope was employed throughout the procedure.The scope was passed through the esophagus with minimal difficulty and the vocal cords were visualized.The ge junction appeared to be below the diaphragm with the diaphragm appearing into view at approximately 37 cm and the ge junction appearing to be in the region of 42-43 cm.The ng tube was seen to be in the esophagus and was passed under endoscopic visualization into the stomach.There appeared to be some evidence of mild gastritis within the stomach.The pylorus was visualized, however, the duodenum was not entered.The patient tolerated the procedure well and the ng tube was placed into the stomach under visualization and taped into position.¿ ¿ (b)(6) 1999: (b)(6) hospitals and clinics.(b)(6), md.Office notes.Seen in the thoracic surgery clinic.27-year-old gentleman who previously underwent a laparoscopic nissen fundoplication in (b)(6) 1998 for severe esophageal reflux disease and a duodenal ulcer.He required a redo procedure in (b)(6) 1998 and had another breakdown with diaphragmatic hernia which was repaired here in (b)(6) of 1998 utilizing a gore-tex patch.He returned today noting that he has had problems for several weeks with persistent severe nausea and now, over the last week, has developed increasingly severe epigastric pain.Has tried to vomit at times but has been unable to do so.Has been able to swallow, though with bread or some other thick sticky foods has noted mild delayed swallowing with the food seeming to hang up in lower chest.Recently begun to have symptoms of reflux.Losing weight because eating aggravates symptoms.Has been under a great deal of stress due to an ongoing divorce.Hospitalized at (b)(6) hospital in (b)(6) about three weeks ago, and was told at that time that his serum amylase was near 400.Apparently he had an abdominal ultrasound, but we do not have the records of that hospitalization.He has also been evaluated in cedar rapids at a pain clinic by dr.Sedlacek, and has undergone placement of a nerve block as well as an epidural catheter because of persistent post-thoracotomy pain which developed following his diaphragmatic repair here in (b)(6) of 1998.This pain persists, unimproved.Exam: abdomen soft with epigastric tenderness.No palpable masses.Bowel sounds were normal.Midline abdominal incision had three nodules consistent with protruding suture material.No erythema, induration, fluctuance, or disruption of the skin.These sites were mildly tender.No peritoneal signs.Mr.(b)(6) has severe persistent nausea, now with abdominal pain and recurrence of reflux.Given his history of duodenal ulcer and severe gastroesophageal reflux disease, we felt it imperative that he undergo endoscopy.Referred to dr.(b)(6) and endoscopy will be scheduled at the earliest possible date.¿ (b)(6) 1999: (b)(6) hospitals and clinics.(b)(6), md.Office notes.Seen in the digestive disease clinic for severe nausea.History of nasal septoplasty in (b)(6) 1998, after which he was found during esophagogastroduodenoscopy to have esophageal lesions and ulcer.He tried multiple different medications without symptomatic relief and repeat esophagogastroduodenoscopy showed abnormal upper esophageal sphincter but normal esophageal motility and normal lower esophageal sphincter tone.Had a nissen fundoplication in (b)(6) 1998, laparoscopic and re-do nissen fundoplication secondary to diaphragmatic hernia in (b)(6) 1998 with gore-tex patch placed.Since surgery, his sensation of acid refluxing into the esophagus and bitter taste in the mouth had completely resolved until one month ago when he states he began to be under extreme stress due to formal separation from his wife.During this whole last year, he has continued to have mild nausea at times and epigastric discomfort, much worse over the last month.Had an episode of wretching three days which has not occurred since near the time of his prior surgery.Has severe stomach soreness and low back pain for the past two days accompanied by anorexia.Two weeks ago, he was hospitalized at (b)(6) hospital in (b)(6) with hyperamylasemia according to the patient.He quit smoking 2-1/2 years ago but restarted during the past month.Weight 60.8 kg.Abdomen soft with normal active bowel sounds.Marked tenderness in the epigastrium and bilateral lower quadrants, left greater than right.Impression/plan: severe reflux and history of ulceration who has had ongoing bout of discomfort during the past year, off proton pump inhibitor medication.It is difficult to distinguish his severe left thorax neuropathy from symptoms of recurrent gastroesophageal reflux disease.It is possible that there has been decompensation of the nissen fundoplication.I recommend esophagogastroduodenoscopy followed by resumption of proton pump inhibitor therapy.Has already been seen in pain clinic, but we did give a prescription for capsaicin cream.Also, plan a 24 hour ph study.¿ (b)(6) 1999: (b)(6) hospitals and clinics.(b)(6), md.Pathology.History: shallow antral ulcers.Diagnosis: 1) esophagus, distal, biopsy: esophagitis.B) stomach, biopsy: chronic gastritis with severe activity and helicobacter organisms.Erosions.Explant procedure: redo left thoracotomy with preservation of latissimus dorsi; creation of intercostal muscle flap; decortication with lysis of adhesions; gastroscopy; removal of infected mesh; primary closure of gastric perforation with intercostal muscle flap overlay; antibiotic irrigation.Explant date: (b)(6), 2000 (hospitalization (b)(6), 2000 ) ¿ (b)(6) 2000: (b)(6) hospitals and clinics.(b)(6), md; (b)(6), md.Operative report.Assistants: (b)(6), md; (b)(6), md.Anesthetist: (b)(6), md; (b)(6), md.Agents: see anesthesia record.Preoperative diagnosis: esophageal perforation.Postoperative diagnosis: gastric perforation with diaphragmatic defect and infected ptfe mesh.Complications: none.Indications: ¿(b)(6) is a 27-year-old male with a history of gastroesophageal reflux disease, who underwent nissen fundoplication in (b)(6) 1998 locally and subsequently underwent redo nissen in (b)(6)1998 with subsequent breakdown of his diaphragm following each nissen repair.He was then repaired using a gore-tex patch on (b)(6) 1998.He recently was readmitted with fever, leukocytosis, and persistent nausea.Egd was performed which demonstrated erosion of the gore-tex graft through the ge junction and subsequent tagged white blood cell scan showed an abscess in the region of the mesh.He presents for removal of his mesh and repair of his perforation.¿ findings: ¿there was evidence of infection with purulent material surrounding the mesh upon removal.There became evident a gastric perforation as opposed to esophageal perforation, which was repaired in several layers.There was evidence of gastric mucosal approximation on gastroscopy following repair of the perforation.¿ description: ¿the patient was brought to the operating room and placed in the supine position.General endotracheal anesthesia was administered.The patient was placed in the right lateral decubitus position and his left chest, abdomen and thigh were prepped and draped in standard sterile fashion.A thoracotomy was made in the prior thoracotomy scar and carried down through the soft tissues with sharp dissection using electrocautery for hemostasis.There was no evidence of compromise of the latissimus dorsi muscle, therefore, this muscle was preserved, as was the serratus anterior muscle.An appropriate interspace was chosen low on the left hemithorax and a rib was resected taking care to stay extrapleural, thereby creating a intercostal muscle flap with the intercostal muscles and pleura above and below the resected rib.This was developed posteriorly to the level of the take-up of the intercostal neurovascular bundle.This was placed out of harms way and several pleural adhesions were taken down with electrocautery.Dissection was performed adjacent to the mediastinum up to the level of approximately the inferior pulmonary vein.There were a fair number of adhesions and edematous tissue present in this region suggesting a chronic inflammation.The mesh was identified and dissected free of its overlying tissue, both anteriorly toward the mediastinum and posteriorly around the anterior portion of the aorta.Upon expression, pus was present during this dissection.Of note, the left hemidiaphragm was noted to be quite intact and the diaphragmatic defect, which was described in the previous op note, was not nearly as large as anticipated.The infected mesh was removed and sent off the table to pathology.Once this was completed, the esophagus was identified below the mesh, as was the previous fundoplication.The previously-placed nasogastric tube was identified and was removed.This elucidated the perforation, which appeared to be below the fundoplication in the stomach, and not in the esophagus, as previously expected.This measured 1.5x2.5 cm in dimension.At this point, dr.Cram scrubbed out of the procedure and gastroscopy was performed with difficulty insufflating the stomach, and inability to visualize the hole.Approximately 9 l of antibiotic irrigation was used to irrigate the entire left hemithorax.The gastrotomy was closed with 3-0 vicryl in interrupted fashion using stitches placed circumferentially around the perimeter of the gastrotomy, approximately 5-7 mm apart, leaving the needle on in anticipation for the intercostal muscle flap overlay.Prior to placing the intercostal muscle flap, the gastrotomy was closed primarily and the intercostal muscle flap was laid over this taking care to not jeopardize the blood supply of the flap.The pleural surface was placed down upon the gastrotomy.The previously-placed circumferential stitches were approximated and the flap appeared to fit snugly over the hole.At this point.Gastroscopy was repeated.And upon retroflexion views, the perforation became evident and there was excellent mucosal-to-mucosal approximation with no evidence of extravasation of gas upon insufflation.The wound was inspected for hemostasis and this was felt to be satisfactory.The left lung was inflated and did not impinge upon our muscle flap and left hemidiaphragm.A bleb was present in the inferior-most portion of the left lower lobe, and this was ruptured with a knife.Chest tubes were placed x 3 with curved tube anteriorly, a curved tube posteriorly, and an anterior chest tube.These were sewn in place using 3-0 nylon in an interrupted fashion.Two jackson-pratt drains were placed, caudad and cephalad to the flap and exited through separate stab wound incisions, then again sewn in place using 3-0 nylon.Closure was performed using 2-0 vicryl for pericostal approximation and 3-0 vicryl to approximate the serratus anterior and latissimus dorsi over the thoracotomy incision.2-0 vicryl was used for dermal approximation, followed by staples and a sterile dressing.The patient was extubated in the recovery room in stable condition.There were no immediate complications evident, and all needle and sponge counts were correct at the end of the case.¿ (b)(6) 2000: (b)(6) hospitals and clinics.(b)(6), md.Pathology.Pn: s-00-02348.History: none given.Diagnosis: site unspecified, removal: gortex mesh.Gross: in formalin is a 16.2 x 12.5 cm piece of rubbery soft mesh with a thickness of 0.1 cm.Specimen is stretchable, has a clamp mark and sutures.A small amount of soft tissue and blood is adherent.No nodules or suspicious areas identified.Specimen is for gross examination only.No sections submitted.Relevant medical information: ¿ (b)(6) 2000: (b)(6) hospitals and clinics.(b)(6), md.Discharge summary.Discharge diagnosis: gastric perforation with abscess and sepsis secondary to previous diaphragmatic rupture and repair with gore-tex graft.Additional diagnoses: gastroesophageal reflux disease and duodenal ulcer, laparoscopic nissen fundoplication in (b)(6) 1998 with breakdown and redo in (b)(6) 1998 with repeat breakdown and diaphragmatic hernia repaired 10/98 with gore-tex patch, postoperative persistent pain syndrome, gastritis positive for h.Pylori and duodenitis in (b)(6) 1999; previous depression, head trauma and nasal fracture with surgery, right inguinal hernia repair, ureter repair.Substance abuse.Significant findings: upper endoscopy on (b)(6) 2000 showed the duodenum and pylorus to be normal.Stomach demonstrated a suture with a hole next to the suture tracking 15 cm retroperitoneal and draining purulent material.Blood cultures were negative.Cultures of the gore-tex implant showed haemophilus species resistant to penicillin and ampicillin and from the paraesophageal abscess fusobacterium species and peptostreptococcus species.Mesenteric angiogram showed no significant disease.Chest ct scan showed postoperative changes consistent with a nissen wrap but no significant abscess was identified.Esophagram on (b)(6) 2000 showed no gastroesophageal junction abnormalities, no leakage of contrast, and postsurgical changes intact.Operations and procedures: endoscopy (b)(6) 2000 with drainage of abscess.(b)(6) 2000, preservation of latissimus dorsi with creation of intercostal muscle flap, decortication and lysis of adhesions via redo left thoracotomy; gastroscopy; removal of infected mesh; primary closure of gastric hole with intercostal muscle flap overlap; and antibiotic irrigation.Hospital course: admitted with fever, chills, leukocytosis, suspected sepsis, and abdominal pain.Endoscopy showed suture with nearby perforation and sinus tract in the stomach.Treated vigorously with intravenous antibiotics and tube feedings.Taken to the operating room on (b)(6) 2000 for surgery as noted above.Postoperatively he recovered well and was discharged in stable condition tolerating a soft diet.Condition on discharge: good.Instructions: inspect incisions for redness, pain, drainage, swelling and monitor temperature.Activity: no lifting greater than 5 lbs.For 6 weeks.Follow up with dr.(b)(6) in thoracic surgery clinic on (b)(6) 2000.¿ (b)(6) 2012: (b)(6), (b)(6), md; (b)(6), md.Office notes.Past medical history of hypertension, asthma, anxiety, gastroesophageal reflux disease status post nissen fundoplication with thoracotomy and resulting chronic abdominal pain and chest pain presents for increasing nausea over the last few days.Nausea occurs 3 times a week associated with epigastric pain and heart burn, the pain about 7/10 achy, doesn't travel anywhere relieved by fentanyl patch.Also complains of chest pain since 2000 when he had the last nissen fundoplication with left thoractomabout [sic], it is about 7/10, constant all the time, described as pins and needles (paresthesias), aggravated by wearing on cloths or anything touches his skin.Location: from the nipple to the level of hip joint, he uses fentanyl patches for the pain and it helps him with the pain.Tobacco use: current; cigarettes 8/day.Weight 133.7 lbs., bmi 21.63.Impression/plan: gastroesophageal reflux disease: phenergan given in office.Refill nexium, phenergan.Chest pain secondary to nerve injury during thoracotomy: refill fentanyl patches.Asthma: stable, continue albuterol.Hypertension: well controlled; diet and exercise.¿ (b)(6) 2013: (b)(6).(b)(6), md; (b)(6), md.Office notes.History of post-traumatic stress disorder, complains of anxious and pain.On fentanyl patch and dilaudid for his chronic neuropathic pain at left-sided chest wall that is not response to lyrica, cymbalta.Neurontin and amitriptyline made him drowsy.About 3 months ago, he went to see new pcp in (b)(6), nm and he took all of medications off and put him on clonazepam 2mg at bedtime.This helps with his anxiety but he is still anxious during the day.Impression/plan: anxiety/post-traumatic stress disorder (ex military): increase clonazepam; start paroxetine; refer to psychiatrist.Neuropathic pain: discuss with primary care physician; will provide 1 month lortab.¿ (b)(6) 2013: (b)(6).(b)(6), rn.Phone call.Pt has long history of thoracic and abdominal surgeries.Does have mesh placement in abdomen.Around 2007 his surgeon in iowa, told him the mesh they used was causing some patients problems and his may have to be replaced.Decided not to address it unless he became symptomatic.Over the years he has developed raised tender places on abdomen.Couple days ago the one on his upper abdomen became more pronounced, raised up about 1/4-1/2 of an inch.Looks like a zit with red head; if he moves it he can see the suture through the skin.Advised him it needed to be addressed today by a physician.I was concerned about it breaking the skin and has a direct line for infection to his abdominal cavity.Explained we have no urgent care appointments until tuesday.He will go to a pns walk in clinic and have it assessed today.¿ (b)(6) 2013: (b)(6).(b)(6), md.Office notes.Er follow up for abscess; needs meds refilled.History of laparotomy for hiatal hernia surgery coming today with skin lesion (pimple) at incision site on the abdominal wall.It happened about a week ago and had er visit where he mentioned that the pimple was numbed topically and squeezed out, responded to bactrim and topical antibiotics but returned back.Had a ct scan abdomen with report mentioning that he has some kind of drain in the left [in] hemothorax, might be done at the time of having diaphragm damage years ago but he is not sure why he has this foreign body.Impression: history of hiatal hernia; chronic pain disorder; carbuncle of abdominal wall.Plan: refer to general surgery.Contact primary care doctor to discuss refills of narcotics.¿ (b)(6) 2013: (b)(6).(b)(6), md.Office notes.Presents for evaluation for chronic abdominal incisional painful lesions.The patient has a laparotomy for hiatal hernia surgery coming [sic].Presents to the clinic for evaluation of his hiatal hernia and foreign body in his thorax from previous thoracotomy.Patient states that he originally had a failed nissen fundoplication many years ago and an open thoracotomy and laparotomy at an outside hospital.Did well however the hiatal hernia recurred.Now evidence of foreign body in the patient's thorax -likely secondary from his last thoracotomy.Does complain of left sided chest pain; takes chronic pain medications at home.Impression: recurrent hiatal hernia and foreign body in left hemi-thorax from previous thoracotomy.Plan: refer to dr.(b)(6)¿s chest surgery clinic.Once patient is scheduled for hiatal hernia repair/removal of foreign body of left hemithorax, then his abdominal incision chronic suture granuloma can be addressed during the same visit to the operating room.¿ (b)(6) 2014: (b)(6).(b)(6), rn.Phone call.Regarding fall, pt tripped and fell on his abdomen, no new trauma noted at the time.This morning pt noticed about 10 cc bloody drainage in his jp drain.Previously it had no blood.Due to the change in color, i instructed him to call the surgeon's office and report the change.Biggest issue is pain management.While in the hospital they increased the dose of his fentanyl patch as well as change the frequency to q 48 hours.Discharged with rx for norco 10/325, not given rx for fentanyl.Out of his previous rx for fentanyl; norco alone not very effective.Would like to pick up rx today for fentanyl.¿ (b)(6) 2014: (b)(6).(b)(6), md; (b)(6), md.Office notes.Seen for follow up after surgery and for medications.Came to the clinic today after he was discharged from the hospital after a long stay for a diagnosis of gastropericardial fistula; status post repair; doing better; better in terms of chest pain.On fentanyl patches and norco.Procedure history: exploration of pericardium and pericardial window (b)(6) 2014; exploratory thoracotomy (b)(6) 2014; creation of pericardial window (b)(6) 2014; esophagogastroduodenoscopy (b)(6) 2014.Smoking status: current smoker, more than 10/day.Weight 134 lbs., bmi 21.71.Impression/plan: gastropericardial fistula: refill fentanyl and norco; follow up with surgery.Post traumatic stress disorder/depression: on cymbalta; symptoms controlled.¿ (b)(6) 2014: (b)(6).(b)(6), md.Office notes.Reviewed patient's chart.He was seen by combest/sunrise clinic on (b)(6) for what appears to be establishment of primary care.He has no pending appointments with our clinic.We will not refill his fentanyl as he has established care elsewhere.He received #5 patches from dr.(b)(6) on (b)(6) 2014.We will not be scheduling further appointments due to multiple no-shows and non-compliance.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
|
|
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.Through gore's investigation and based on the available information 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.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." the instructions for use further warn: "strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material." 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 persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, 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
|
|
|
