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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® PREPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Back to Search Results |
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| Catalog Number |
GKWV1015 |
| Medical Device Problem Code |
Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Codes |
Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
06/21/2022
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 17: (b)(6) medical center.(b)(6) md.Operative report.Assistant: (b)(6) csfa and (b)(6) md.Procedure: multiport robotic cholecystectomy, umbilical hernia repair and icg fluoroscopy.Preoperative diagnoses: cholecystitis and polycystic liver.Postoperative diagnoses: cholecystitis, polycystic liver and umbilical hernia.Anesthesia: general.Estimated blood loss: 10 ml.Complications: none.- findings: distended gallbladder, serosal adhesions covering 75% of the gallbladder surface with polycystic liver disease noted.These were simple appearing cysts scattered throughout the entire liver.A critical view of safety was obtained after isolating the cystic duct and artery circumferentially.This view was confirmed with icg fluorescence imaging.The gallbladder was removed within an endopouch through the umbilical hernia.The hernia was repaired with 2 interrupted vicryl sutures using a weck efx shield closure device.- procedure: ¿after obtaining informed consent, the patient was brought to the operating room and placed supine on the operating room table.A general anesthetic was administered and an oral airway was placed.The patient's abdomen was then clipped, prepped and draped in standard fashion.A supraumbilical skin incision was made after the administration of local anesthetic.A pneumoperitoneum was established using a veress needle technique.A 5 mm trocar was placed under direct laparoscopic vision.Additional trocars as outlined above were placed under direct vision.The robotic camera trocar was placed.The camera was placed.The assistant port was placed.The gallbladder was grasped and retracted cephalad.The appropriate size curved cannulas were then selected.The assistant port was removed.The curved cannulas were placed under direct vision.The robotic arms were docked.The assistant port was placed.I then transitioned to the console.General laparoscopy was performed.The visualized portions of the small bowel, colon, omentum, stomach, and liver were normal.There were no other pathologic findings identified.The gallbladder was as described above.I therefore proceeded with its removal.The dome of the gallbladder was grasped and retracted cephalad.All inflammatory adhesions were carefully taken down using a combination of sharp and blunt dissection.The infundibulum was exposed, grasped and retracted laterally.The peritoneum overlying the junction of the gallbladder with the cystic duct was scored sharply with electrocautery.This incision was carried along the right and left sides of the gallbladder fossa to obtain the critical view.The cystic duct and artery were isolated circumferentially.Both structures were clipped and divided.Hook electrocautery was then used to dissect the gallbladder free from the liver bed.The gallbladder was extracted through the subxiphoid trocar site without difficulty.It was passed off the table for permanent sectioning.The right upper quadrant was inspected.The liver bed was made hemostatic.The clips were inspected and found to be intact.There was no evidence of bile leakage from the liver bed or the cystic duct stump.Satisfied, i proceeded with closure.Marcaine was infiltrated along the diaphragm.The abdomen was desufflated.The trocars were removed.The skin incisions were closed using 40 monocryl in subcuticular fashion.Sterile bandages were applied using dermabond.The patient tolerated the procedure well.Sponge and needle counts were correct at the end of case.The patient was extubated in the operating room and transported to the recovery room in good condition.¿.- (b)(6) md.Pathology report.Specimen: gallbladder.¿received intact: yes.Size: 7.5 x 3.5 x 3.2 cm.Serosa: pink-tan-gray and focally fatty.Lymph node identified: no.Cystic duct: patent.Mucosa: dark brown and slightly velvety.Wall thickness: up t o 0.2 cm.Contents: thin hemorrhagic fluid with no calculi grossly identified.¿.(b)(6) 2017: (b)(6) medical center.(b)(6) md.Operative report.Procedure: ercp.Preoperative diagnosis: bile leak.Anesthesia: general.Impression: the major papilla appeared normal.A bile leak was found.A biliary sphincterotomy was performed.One plastic stent was placed into the common bile duct.(b)(6) 2017: (b)(6) medical center.(b)(6) do.Operative report.Procedure: ercp.Preoperative diagnosis: followup of bile leak.Anesthesia: propofol.Impression: stent removed.Normal endoscopic retrograde cholangiopancreatography.Discharged to home.(b)(6) 2018: (b)(6) medical center.(b)(6) md.Operative report.Assistant: (b)(6) csfa.Procedure: multiport robotic recurrent umbilical hernia repair with mesh.Implant: symbotex, 12cm.Preoperative and postoperative diagnosis: recurrent umbilical hernia.Anesthesia: general.Estimated blood loss: 10 ml.Specimens: sac ¿ discarded.Complications: none.- findings: 4x3 cm umbilical hernia.No mesh or suture material identified.Closed primarily and covered with 12cm symbotex mesh.- procedure: ¿after obtaining informed consent, the patient was brought to the operating room and placed supine on the operating table.A general anesthetic was administered and an oral airway was placed.The patient's abdomen was prepped and draped in standard fashion.A subcostal skin incision was made after administration of local anesthetic.A pneumoperitoneum was established using a veress needle technique.Next, a 5-mm trocar was placed under direct laparoscopic vision.Robotic trocars were placed as well as an assist port.The robot was docked from a lateral approach.I transitioned to the console.The abdomen was inspected.All adhesions to the anterior abdominal wall were carefully lysed.The hernia was inspected.Any incarcerated contents were reduced.The fascial edges were debrided and prepared for closure.The fascia was then closed primarily with a running v-loc suture.The suture was reversed to set the barbs.The mesh was opened and placed intraperitoneally.It was anchored to the abdominal wall with temporary transabdominal fixation sutures.The mesh was then sewn around the perimeter with a running 0 ethibond suture on an mh needle.The repair was done at the lowest intra-abdominal working pressure feasible.There were no intraabdominal complications noted.The instruments were removed.The abdomen was deflated.The trocars were removed.The incision was closed in layers and covered with dermabond.The patient tolerated the procedure well.Sponge and needle counts were correct at the end of the case.The patient was extubated in the operating room and transferred to the recovery room in good condition.¿.- implant.Umbilical.¿mesh surgical symbotex 3.3x2.3mm 12cm 2 side composite monofilament bioabsorbable film sterile polyester collagen 3d round disposable green white laparoscopic ventral hernia repair.¿ implant preoperative complaints: (b)(6) 2019: (b)(6) medical center.(b)(6) md.Indications: ¿mrs.(b)(6) is a 49-year -old caucasian lady who was admitted for further evaluation and management of abdominal pain.She has history of previous robotic ventral hernia repair by dr.Dickens last year via an intraperitoneal approach.She developed recurrence sometime thereafter and was actually scheduled to have consultation with dr.Cole later this week, however presented to the er with the above.She was found to have small bowel obstruction secondary to incarcerated recurrent hernia by ct imaging.She was taken to the operating room for urgent repair.¿.Implant procedure: recurrent ventral hernia repair with mesh, incarcerated.Wound vac placement greater than 50 cm2.[implant: gore® synecor preperitoneal biomaterial, gkwv1015/(b)(6), 10cm x 15cm, oval].Implant date: (b)(6) 2019 [hospitalization dates (b)(6) 2019].(b)(6) 2019: (b)(6) medical center.(b)(6) md.Operative report.Assistants: (b)(6), aprn-cns, rnfa and (b)(6), pa -s2.Preoperative and postoperative diagnosis: small bowel obstruction secondary to incarcerated recurrent ventral hernia.Anesthesia: general.Estimated blood loss: 30 ml.Specimens: hernia sac and explanted mesh.Complications: none.Wound class: clean contaminated.Findings: ¿approximately 8 x 9 cm recurrent ventral hernia defect centered at the umbilicus.Hernia contained a loop of chronically inflamed but completely viable small bowel as well as omentum which was reduced.Previously placed mesh was visualized in the intraperitoneal position and appeared to have migrated just slightly to the left allowing recurrence of the hernia.Portions of the mesh were explanted.Hernia then repaired in an onlay fashion; fascia was primarily closed with #1 stratafix in a 15 x 10 cm oval piece of synecor mesh was placed in the only [sic] position after developing small subcutaneous flaps.Jp drain left above the mesh and primary closure obtained in layers.Prevena wound vac applied.¿.Procedure: ¿informed consent was obtained preoperatively in which the risks benefits and alternatives to the planned procedure were explained at length to the patient and/or guardian who expressed understanding and wished to proceed.On the day of the procedure the patient was correctly identified in the holding area and then brought back and placed supine on operating room table.Sequential compression devices were placed, preoperative antibiotics were given, foley catheter was placed, and after adequate anesthesia and bilateral tap blocks were obtained, the patient's abdomen was prepped and draped in the usual sterile fashion.First a vertical midline incision centered at the umbilicus was made with a scalpel.This was deepened through subcutaneous tissues with electrocautery.Hernia sac was immediately encountered and carefully dissected free from surrounding subcutaneous fat.Hernia sac was isolated all the way down to the fascia and the abdominal wall was quite thick given the patient's body habitus.With hernia sac now isolated the overlying umbilicus was dissected off and the hernia sac entered proper.A large amount of clear serous fluid was obtained and suctioned clear.The hernia sac was further opened and the contents inspected and found to contain a chronically inflamed loop of small bowel but which was completely viable.Also noted was chronically incarcerated but viable omentum which was significantly adhered to the surrounding hernia sac.The omentum was dissected free and its along with a loop of small bowel was reduced back into the peritoneal cavity.The hernia sac was excised down to the fascial edge and passed off for permanent pathology.At this point, we then made plans for repair.The defect measured approximately 8 x 9 cm in general round dimension.Given the fact that the patient's suffered a recurrence with a previous intraperitoneal approach, i elected to proceed with recurrent repair in an onlay fashion.Subcutaneous flaps were developed by undermining some cutaneous fat off of the fascia with electrocautery taking care to preserve perforators.Alternating 0 pds and prolene sutures were then placed through the fascia in multiple o'clock positions and the tails left long and tagged.The defect was then closed with #1 strata fix in a running fashion and there was no undue tension in doing so.A 10 x 15 cm oval piece of synecor mesh was then placed over the fascia and the previous pds and prolene sutures brought up through the mesh using a suture passer device again in the multiple o'clock positions.The sutures were tied down the mesh was noted to lie flat against the fascia without undue tension or torsion or kinking.The area was copiously irrigated and suctioned clear.We then proceeded with closure.A 19 french round fluted blake drain was placed on top of the mesh and brought to the left lower quadrant with stab incision.It was secured in place with a 2-0 nylon drain stitch.The subcutaneous fat was then reapproximated over the drain using interrupted 0 vicryl sutures.The deep dermal layer was reapproximated interrupted 3-0 vicryl sutures.The skin was re-approximate skin staples.In order to reduce seroma, hematoma, and infection risk, a prevena wound vac was applied.The purple sponge was cut to the appropriate fit and placed upon the incision and secured to the suction tubing to 125mmhg continuous suction with good seal and no leaks.Total wound vac area applied was greater than 50 cm2.After confirming twice that the needle, sponge, and instrument counts were correct, general anesthesia was terminated.Sterile dressings were applied, foley catheter was discontinued, and the patient was taken to recovery in stable condition.¿.(b)(6) 2019: (b)(6) medical center.Implant record.¿mesh surgical gore synecor preperitoneal biomaterial synecor oval l15 cm x w10 cm preperitoneal knit web.¿ model/cat no.: gkwv1015.Serial no: (b)(6).Laterality: midline.Area: abdomen.Action: implanted.Number used: 1.Manufacturer: wl gore and associates, inc.(b)(6) 2019: (b)(6) medical center.Implant sticker: gore® synecor preperitoneal biomaterial.Ref: gkwv1015.Sn: (b)(6).Location: abdomen.Quantity: 1.Manufacturer: gore.Expiration: 3/26/22.(b)(6) 2019: (b)(6) medical laboratory.(b)(6), md.Pathology report.Specimen: hernia sac.History: ventral hernia with bowel obstruction.- diagnosis: soft tissue, ventral hernia, herniorrhaphy, membranous fibroadipose tissue, consistent with hernia sac; mesothelial hyperplasia and chronic inflammation; focal foreign body reaction.- gross examination: received in formalin in a container labeled with patient name and as "hernia sac".Membranous tissue maximal dimension: 10.1 cm.Attached fat: yes.Measurement: up to 13.5 cm.Embedded with this tissue on multiple fragments is a tan mesh-like material and focal green sutures.Partial explant preoperative complaints: (b)(6) 2020: (b)(6) medical center.(b)(6) md.Indication: ¿mrs.(b)(6) is a 49-year-old caucasian lady well known previously to me.She presented acutely last summer with recurrent ventral hernia and is status post recurrent ventral herniorrhaphy with mesh by me via an open onlay approach in (b)(6) 2019.She was followed postoperatively in clinic and her course was complicated by postoperative seroma which underwent ir aspiration that was positive for mssa.Plans were for then formal ir drain placement but the patient did not follow through with this due to improvement in her symptoms.She then presented this week with the opening of a wound at the inferior apex of her well-healed incision and ct imaging suggested abscess but showed no recurrence of hernia.She was taken to the operating room for formal incision and drainage and debridement, possible mesh explantation.¿.Partial explant procedure: incision and drainage, complicated, abdominal wall abscess.Excisional debridement, subcutaneous tissues, 84 cm2.Explantation of hernia mesh.Wound vac placement greater than 50 cm2.Partial explant date: (b)(6) 2020 (hospitalization dates (b)(6) 2020).(b)(6) 2020: (b)(6) medical center.(b)(6) md.Operative report.Assistant: (b)(6) cfa.Preoperative and postoperative diagnosis: infected postoperative seroma/ abdominal wall abscess.Anesthesia: general.Estimated blood loss: 5 ml.Specimens: wound swab for gram stain, culture, and sensitivity.Hernia mesh.Complications: none.Wound class: clean contaminated.Procedure: ¿informed consent was obtained preoperatively in which the risks benefits and alternatives to the planned procedure were explained at length to the patient and/or guardian who expressed understanding and wished to proceed.On the day of the procedure the patient was correctly identified in the holding area and then brought back and placed supine on operating room table.Sequential compression devices were placed, the patient was already on therapeutic preoperative antibiotics, and after adequate anesthesia was obtained, the patient's abdomen was prepped and draped in the usual sterile fashion.First the patient's previous well-healed midline incision was infiltrated with local anesthetic.Incision was then performed with a scalpel starting at the small less than 1 cm round wound at the inferior apex and extended upwards around the umbilicus.Dissection was carried down through the subcutaneous fat with electrocautery entering the seroma cavity which contained a large amount of just slightly cloudy almost clear tan fluid, swabs which were taken and sent for gram stain, culture, and sensitivity.The seroma cavity was then opened for the length of skin incision and was found to measure 14 x 6 cm in size.There was a large amount of fibrinous exudate and sinus granulation but no gross purulence or necrotic tissue.The mesh appeared to be well incorporated centrally with only small edges of exposed bare mesh.This along with some prolene suture were cut with the curved mayo scissors and passed off for gross pathology.Then using a sharp curette the nonviable exudate and chronic sinus granulation was excisionally debrided on the order of 84 cm2.Once complete there was no exposed bare mesh or other foreign bodies.The wound base was pink and as noted above previous mesh was well incorporated not visible and there was no evidence of recurrence of hernia.The wound was then copiously irrigated with betadine containing saline and suctioned clear.Given the above changes i elected to obtain closure with the wound vac device.The black granufoam sponge was cut to the appropriate fit and placed within the wound followed by the plastic adhesive drapes and suction tubing to 125 mmhg continuous suction with good seal and no leaks.Total wound vac area applied was greater than 50 cm2.After confirming twice that the needle, sponge, and instrument counts were correct, general anesthesia was terminated.Sterile dressings were applied and the patient was taken to recovery in stable condition.¿.(b)(6) 2020: (b)(6) medical laboratory.(b)(6) md.Pathology report.Specimen: hernia mesh.History: abdominal wall abscess at site of surgical wound.- diagnosis: prosthesis, mesh, excision multiple fragments of synthetic mesh and suture; no soft tissue is present (gross diagnosis).- gross examination: received in formalin in a container labeled with the patient's name and "hernia mesh" are multiple irregularly shaped fragments of tan synthetic mesh which measure 2.5 x 1.1 x 0.7 cm in aggregate.Also present is a small segment of suturing.The specimen is submitted for gross examination only.No sections are taken for histologic examination.Relevant medical information: (b)(6) 2022: (b)(6) medical center [(b)(6)].(b)(6) , md.Emergency medicine note.Cc [chief complaint]: ¿abdominal pain.¿ hpi [history of present illness]: ¿tamera l may is a 52-year-old female with a pmh [primary history] of hypertensive heart disease, htn, bipolar 2, and paroxysmal a.Fib [atrial fibrillation] who presents today with severe, generalized, and constant abdominal pain since 2300.Patient states that she previously had a small bowel obstruction, and this feels exactly like that.Associated with nausea and multiple episodes of emesis.Patient states that she has not been able to pass gas or had a bowel movement since the pain began.No blood noted in her stool before this.No blood in her vomit.No pain with urination.¿ ros [review of systems]: ¿gastrointestinal: positive for abdominal pain, constipation, nausea and vomiting.Negative for diarrhea.¿ pe [physical examination]: ¿abdominal: general: abdomen is flat.There is no distension.Palpations: abdomen is soft.Tenderness: there is no abdominal tenderness.There is guarding (voluntary.) there is no rebound.¿ ¿summary statement: 52-year-old f with a pmh of hypertensive heart disease, htn, bipolar 2, and paroxysmal a.Fib presents with generalized abdominal pain worse in the suprapubic region associated with nausea and vomiting.Patient appears in acute distress and uncomfortable.Vitals show hypotension.Patient given 30 cc/kg bolus of normal saline, and continues to have low blood pressures.Patient started on levophed.Ct scan of the abdomen pelvis shows possible pyelonephritis versus renal infarct.Patient [sic] foley catheter and with no urine return.Bedside ultrasound reveals reveals [sic] no obvious bladder versus very collapsed bladder.Patient with an aki [acute kidney injury] with a creatinine of 2.35.Wbc [white blood cells] 26.76.Patient started on cefepime and vancomycin.Patient discussed with icu [intensive care unit] service who agrees to come see the patient.¿.(b)(6) 2022: (b)(6).(b)(6), do.Ed [emergency department] note.¿i performed a history and physical exam of the patient and discussed her management with the resident.I reviewed the resident's note and agree with the documented findings and plan of care.Attending physician's note is as follows: patient presents to the emergency department with generalized abdominal pain similar to previous bowel obstruction that occurred several years ago.She states that her symptoms have been worsening since 11 pm.She states it is worse with movement.The pain radiates to her back.She had a bowel movement yesterday morning and it was a dark stool.She admits to having nausea and vomiting.She has had bilious emesis.She has vomited several times.She admits to having shortness of breath that she thinks is due to anxiety.She denies fever, cough, congestion, chest pain, dysuria, hematuria, edema and calf pain.On arrival to the emergency department, patient is well -appearing, moderate distress due to pain, vital signs are stable.Lung sounds are clear.Heart sounds are normal.Abdomen is diffusely tender to palpation.Mucous membranes are moist.Capillary refill is less than 2 seconds.Patient is neurologically intact.There is no lower extremity edema or calf tenderness.Ekg reveals nonspecific st abnormalities.Ct scan, urinalysis and blood work are pending.Patient given morphine and zofran and normal saline for her symptoms.See resident note for results and disposition.The central line procedure was performed by the resident in my presence and i was physically present during all key portions of procedure.¿.(b)(6) 2022: (b)(6).(b)(6) , aprn-cnp.(b)(6), md.Critical care history and physical.Chief complaint: ¿abdominal pain, obstipation, nausea, emesis.¿ clinical course & daily progress: ¿(b)(6) is a 52 y.O.Female with pmh as detailed below who presented on (b)(6) 2022 with diffuse abdominal pain which was most consistent with prior episode of bowel obstruction.She presented profoundly hypotensive and this did not improve despite iv fluid resuscitation.Ct of the abdomen pelvis was completed demonstrating distended loops of small bowel in the lower abdomen and pelvis with decompressed colon most consistent with mild partial distal small bowel obstruction due to adhesions.She has a past medical history significant for paroxysmal atrial fibrillation (flecainide and no anticoagulation), hypertension, chronic pain, gerd, anxiety, obstructive sleep apnea without cpap adherence and prior bowel obstruction.Her pain started at 11 pm.She had some barbecue and about a total of 4 vodka cranberry drinks on (b)(6).Following the onset of pain, she was unable to pass gas, have a bowel movement, and she experienced nausea and emesis.She denies any dysuria, fever or chills prior to admission.She reports the pain that she is experiencing is exactly the same as her prior bowel obstruction.Prior to the events of yesterday she was in her normal state of health.Currently, dilaudid is only thing that is helping for her pain control.The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past medical history, past social history, past surgical history and problem list.¿ physical examination: ¿abdominal: general: there is no distension.Palpations: abdomen is soft.Tenderness: there is no abdominal tenderness.¿ assessment/plan: ¿infectious disease: shock, likely secondary to sirs, cannot rule out sepsis.Broad spectrum abx coverage w/ vancomycin, cefepime, and flagyl.Blood cultures (b)(6).Check procalcitonin.¿ ¿gastrointestinal: acute abdomen: suspect bowel obstruction.Surgical consult.Ng tube to lis.Npo.Famotidine for gerd.¿ plan & disposition: ¿surgical consult, suspect sbo, will continue supportive care as above.¿.(b)(6) 2022: (b)(6).(b)(6) md.Ct abdomen pelvis w contrast.Clinical history: ¿bowel obstruction high-grade suspected.Abdominal pain and distention.¿ findings: ¿numerous cysts are present throughout the kidneys and liver, probably a form of polycystic kidney or polycystic liver disease.The right kidney is enlarged compared to the left.The cysts in the kidneys require no further follow-up at this time.Low-density is present in the superior pole of the left kidney that does not appear to be cystic.Multiple areas of low density are present throughout the left kidney.There may be some similar areas in the right kidney, but most of the right kidney findings or cystic.The pancreas, adrenals, spleen appear normal.Gallbladder not well visualized and may be absent.Atherosclerotic disease of the aorta.A few distended loops of small bowel are present in the lower abdomen.Bladder and uterus appear unremarkable.No free fluid.Colon is decompressed.Postoperative changes at the umbilicus probably previous hernia repair.Lumbar spine appears acutely intact.¿ impression: ¿low-density areas present in the left kidney could be underlying pyelonephritis or renal infarcts and appear acute or subacute.Some distended loops of small bowel are present in the lower abdomen and pelvis with decompressed colon.This could be a mild partial distal small bowel obstruction due to adhesions.Transition point is probably in the pelvis.Polycystic kidney and liver findings.Other incidental findings.¿.See attachment.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® synecor® preperitoneal 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.".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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Event or Problem Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2018 whereby a gore® synecor® preperitoneal biomaterial was implanted.The complaint alleges that on (b)(6) 2022, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: death (b)(6) 2022 - bowel obstruction, adhesions, pain, infection, chronic wound.Additional event specific information was not provided.
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Additional Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: ¿ (b)(6) 2017: (b)(6) medical center.(b)(6), md.Operative report.Assistant: (b)(6), csfa and (b)(6), md.Procedure: multiport robotic cholecystectomy, umbilical hernia repair and icg fluoroscopy.Preoperative diagnoses: cholecystitis and polycystic liver.Postoperative diagnoses: cholecystitis, polycystic liver and umbilical hernia.Anesthesia: general.Estimated blood loss: 10 ml.Complications: none.- findings: distended gallbladder, serosal adhesions covering 75% of the gallbladder surface with polycystic liver disease noted.These were simple appearing cysts scattered throughout the entire liver.A critical view of safety was obtained after isolating the cystic duct and artery circumferentially.This view was confirmed with icg fluorescence imaging.The gallbladder was removed within an endopouch through the umbilical hernia.The hernia was repaired with 2 interrupted vicryl sutures using a weck efx shield closure device.- procedure: ¿after obtaining informed consent, the patient was brought to the operating room and placed supine on the operating room table.A general anesthetic was administered and an oral airway was placed.The patient's abdomen was then clipped, prepped and draped in standard fashion.A supraumbilical skin incision was made after the administration of local anesthetic.A pneumoperitoneum was established using a veress needle technique.A 5 mm trocar was placed under direct laparoscopic vision.Additional trocars as outlined above were placed under direct vision.The robotic camera trocar was placed.The camera was placed.The assistant port was placed.The gallbladder was grasped and retracted cephalad.The appropriate size curved cannulas were then selected.The assistant port was removed.The curved cannulas were placed under direct vision.The robotic arms were docked.The assistant port was placed.I then transitioned to the console.General laparoscopy was performed.The visualized portions of the small bowel, colon, omentum, stomach, and liver were normal.There were no other pathologic findings identified.The gallbladder was as described above.I therefore proceeded with its removal.The dome of the gallbladder was grasped and retracted cephalad.All inflammatory adhesions were carefully taken down using a combination of sharp and blunt dissection.The infundibulum was exposed, grasped and retracted laterally.The peritoneum overlying the junction of the gallbladder with the cystic duct was scored sharply with electrocautery.This incision was carried along the right and left sides of the gallbladder fossa to obtain the critical view.The cystic duct and artery were isolated circumferentially.Both structures were clipped and divided.Hook electrocautery was then used to dissect the gallbladder free from the liver bed.The gallbladder was extracted through the subxiphoid trocar site without difficulty.It was passed off the table for permanent sectioning.The right upper quadrant was inspected.The liver bed was made hemostatic.The clips were inspected and found to be intact.There was no evidence of bile leakage from the liver bed or the cystic duct stump.Satisfied, i proceeded with closure.Marcaine was infiltrated along the diaphragm.The abdomen was desufflated.The trocars were removed.The skin incisions were closed using 40 monocryl in subcuticular fashion.Sterile bandages were applied using dermabond.The patient tolerated the procedure well.Sponge and needle counts were correct at the end of case.The patient was extubated in the operating room and transported to the recovery room in good condition.¿ - (b)(6) 2017: (b)(6), md.Pathology report.Specimen: gallbladder.¿received intact: yes.Size: 7.5 x 3.5 x 3.2 cm.Serosa: pink-tan-gray and focally fatty.Lymph node identified: no.Cystic duct: patent.Mucosa: dark brown and slightly velvety.Wall thickness: up to 0.2 cm.Contents: thin hemorrhagic fluid with no calculi grossly identified.¿ ¿ (b)(6) 2017: (b)(6) medical center.Inpatient admission.- (b)(6) 2017: (b)(6), aprn-cns.History and physical.Chief complaint: abdominal pain, nausea and vomiting.Abdominal exam: soft, tenderness to palpation noted, mildly across the abdomen, area of redness noted, but it looks like spreading downward.Dressing is clean, dry and intact.Admitted for pain management and possible postop infection.- (b)(6) 2017: (b)(6), md.Radiology report.Ct abdomen and pelvis with contrast.Impression: findings compatible with recent laparoscopic cholecystectomy with expected post surgical edematous changes in the region of the gallbladder fossa and right upper abdomen and mesenteric region as well as about the umbilicus anterior to the anterior abdominal wall period no evidence for abscess.Findings compatible with polycystic liver and kidney disease.- (b)(6) 2017: (b)(6), md.Operative report.Procedure: ercp.Preoperative diagnosis: bile leak.Anesthesia: general.Impression: the major papilla appeared normal.A bile leak was found.A biliary sphincterotomy was performed.One plastic stent was placed into the common bile duct.- (b)(6) 2017: (b)(6), md.Radiology.Procedure: ct- guided drainage of biloma, gallbladder fossa.Indication: persistent bile leak following robotic cholecystectomy despite placement of a stent in the common duct.- (b)(6) 2017: (b)(6) do.Discharge summary.Discharge diagnoses: status post ct-guided penrose drain placement and drainage, postoperative day #5.Status post biliary sphincterectomy and placement of plastic stent at the common bile duct secondary to bile leakage, post-procedure day #5.Status post cholecystectomy on (b)(6) 2017, postoperative day #10.Postoperative abdominal wall cellulitis, symptoms resolved.Presumptive peritonitis, symptoms improved.She will have a biliary stent for approximately 6 weeks.Jp drain intact, draining clear bilious fluid.To have home health follow up.Discharged to home in good condition.¿ (b)(6) 2017: (b)(6) medical center.(b)(6), do.Operative report.Procedure: egd (esophagogastroduodenoscopy): with possible biopsy, ercp (endoscopic retrograde cholangiopancreatography.Preoperative diagnosis: followup of bile leak.Anesthesia: propofol.Impression: stent removed.Normal endoscopic retrograde cholangiopancreatography.Discharged to home.¿ (b)(6) 2018: (b)(6) medical center.(b)(6), md.Operative report.Assistant: (b)(6) csfa.Procedure: multiport robotic recurrent umbilical hernia repair with mesh.Implant: symbotex, 12cm.Preoperative and postoperative diagnosis: recurrent umbilical hernia.Anesthesia: general.Estimated blood loss: 10 ml.Specimens: sac ¿ discarded.Complications: none.- findings: 4x3 cm umbilical hernia.No mesh or suture material identified.Closed primarily and covered with 12cm symbotex mesh.- procedure: ¿after obtaining informed consent, the patient was brought to the operating room and placed supine on the operating table.A general anesthetic was administered and an oral airway was placed.The patient's abdomen was prepped and draped in standard fashion.A subcostal skin incision was made after administration of local anesthetic.A pneumoperitoneum was established using a veress needle technique.Next, a 5-mm trocar was placed under direct laparoscopic vision.Robotic trocars were placed as well as an assist port.The robot was docked from a lateral approach.I transitioned to the console.The abdomen was inspected.All adhesions to the anterior abdominal wall were carefully lysed.The hernia was inspected.Any incarcerated contents were reduced.The fascial edges were debrided and prepared for closure.The fascia was then closed primarily with a running v-loc suture.The suture was reversed to set the barbs.The mesh was opened and placed intraperitoneally.It was anchored to the abdominal wall with temporary transabdominal fixation sutures.The mesh was then sewn around the perimeter with a running 0 ethibond suture on an mh needle.The repair was done at the lowest intra-abdominal working pressure feasible.There were no intraabdominal complications noted.The instruments were removed.The abdomen was deflated.The trocars were removed.The incision was closed in layers and covered with dermabond.The patient tolerated the procedure well.Sponge and needle counts were correct at the end of the case.The patient was extubated in the operating room and transferred to the recovery room in good condition.¿ - implant.Umbilical.¿mesh surgical symbotex 3.3x2.3mm 12cm 2 side composite monofilament bioabsorbable film sterile polyester collagen 3d round disposable green white laparoscopic ventral hernia repair.¿ ¿ (b)(6) 2018: (b)(6) medical center.(b)(6), md.Radiology.Ct scan abdomen.A periumbilical fluid collection is identified.Sharply circumscribed subcutaneous fluid collection seen about the umbilicus measuring 4.7 x 7.7 cm in greatest ap and rl dimension.No underlying defect in the anterior abdominal wall is seen.Surgical clips are seen beneath the anterior abdominal musculature to the right.¿ (b)(6) 2018: (b)(6) medical center.(b)(6), md.Radiology.Ct guided aspiration of abdominal wall fluid collection.Impression: the abdominal wall fluid collection represented a seroma in which serosanguinous fluid was obtained.A drainage catheter was not left in place.Implant preoperative complaints: ¿ (b)(6) 2019: (b)(6) medical center.(b)(6) do.Emergency department.Chief complaint: abdominal pain.Patient presented in moderate distress, breathing deeply, complaining of chest and abdominal pain radiating into her back.She appears to have significant ascites.History of present illness: 49 yo w/ pmh of alcohol abuse and polycyctic [sic] kidney and liver disease who presents with abdominal pain radiating to the back "around the sides".It is sharp, she states it started yesterday and has progressively worsened overnight and this morning/afternoon.This afternoon she began having episodes of green/yellow emesis.She has had fluid drained off her belly in 2018 and takes a "water pill daily".Abdominal exam: she exhibits distension, fluid wave and ascites.There is tenderness.A hernia is present.Hernia confirmed positive in the ventral area.Admit.¿ (b)(6) 2019: (b)(6) medical center.(b)(6), md.History and physical.Patient with history of umbilical hernia repair in the (b)(6) 2018, hypertension and anxiety disorder presented with sudden onset abdominal pain.Onset was 4 hours prior to presentation.Patient describes it as a sharp periumbilical pain that radiated to the back.There was nausea and vomiting.Patient also had a bowel movements.Last bowel movement was 2 hours ago.Pain is poorly relieved by analgesics.During evaluation in the er ct scan of the abdomen showed incarcerated ventral hernia.Patient will be admitted for further management in consultation with the general surgeon.Abdominal exam: ¿no distension.Ascites is not present.¿ ct abdomen: there appears to be small bowel obstruction related to nature abdominal wall hernia.There are thick-walled loops of small bowel present both intraperitoneal and in the hernia sac.There is fluid and edema within the hernia sac.Findings are concerning for incarceration and possible ischemia.Admit with ventral hernia with bowel obstruction.¿ (b)(6) 2019: (b)(6) medical center.(b)(6), md.Indications: ¿mrs.(b)(6) is a 49-year -old caucasian lady who was admitted for further evaluation and management of abdominal pain.She has history of previous robotic ventral hernia repair by dr.Dickens last year via an intraperitoneal approach.She developed recurrence sometime thereafter and was actually scheduled to have consultation with dr.(b)(6) later this week, however presented to the er with the above.She was found to have small bowel obstruction secondary to incarcerated recurrent hernia by ct imaging.She was taken to the operating room for urgent repair.¿ implant procedure: recurrent ventral hernia repair with mesh, incarcerated.Wound vac placement greater than 50 cm2.[implant: gore® synecor preperitoneal biomaterial, gkwv1015/2(b)(6), 10cm x 15cm, oval] implant date: (b)(6), 2019 [hospitalization dates (b)(6) 2019] ¿ (b)(6) 2019: (b)(6) medical center.(b)(6), md.Operative report.Assistants: (b)(6)i, aprn-cns, rnfa and (b)(6), pa -s2.Preoperative and postoperative diagnosis: small bowel obstruction secondary to incarcerated recurrent ventral hernia.Anesthesia: general.Estimated blood loss: 30 ml.Specimens: hernia sac and explanted mesh.Complications: none.¿ wound class: clean contaminated.¿ findings: ¿approximately 8 x 9 cm recurrent ventral hernia defect centered at the umbilicus.Hernia contained a loop of chronically inflamed but completely viable small bowel as well as omentum which was reduced.Previously placed mesh was visualized in the intraperitoneal position and appeared to have migrated just slightly to the left allowing recurrence of the hernia.Portions of the mesh were explanted.Hernia then repaired in an onlay fashion; fascia was primarily closed with #1 stratafix in a 15 x 10 cm oval piece of synecor mesh was placed in the only [sic] position after developing small subcutaneous flaps.Jp drain left above the mesh and primary closure obtained in layers.Prevena wound vac applied.¿ ¿ procedure: ¿informed consent was obtained preoperatively in which the risks benefits and alternatives to the planned procedure were explained at length to the patient and/or guardian who expressed understanding and wished to proceed.On the day of the procedure the patient was correctly identified in the holding area and then brought back and placed supine on operating room table.Sequential compression devices were placed, preoperative antibiotics were given, foley catheter was placed, and after adequate anesthesia and bilateral tap blocks were obtained, the patient's abdomen was prepped and draped in the usual sterile fashion.First a vertical midline incision centered at the umbilicus was made with a scalpel.This was deepened through subcutaneous tissues with electrocautery.Hernia sac was immediately encountered and carefully dissected free from surrounding subcutaneous fat.Hernia sac was isolated all the way down to the fascia and the abdominal wall was quite thick given the patient's body habitus.With hernia sac now isolated the overlying umbilicus was dissected off and the hernia sac entered proper.A large amount of clear serous fluid was obtained and suctioned clear.The hernia sac was further opened and the contents inspected and found to contain a chronically inflamed loop of small bowel but which was completely viable.Also noted was chronically incarcerated but viable omentum which was significantly adhered to the surrounding hernia sac.The omentum was dissected free and its along with a loop of small bowel was reduced back into the peritoneal cavity.The hernia sac was excised down to the fascial edge and passed off for permanent pathology.At this point, we then made plans for repair.The defect measured approximately 8 x 9 cm in general round dimension.Given the fact that the patient's suffered a recurrence with a previous intraperitoneal approach, i elected to proceed with recurrent repair in an onlay fashion.Subcutaneous flaps were developed by undermining some cutaneous fat off of the fascia with electrocautery taking care to preserve perforators.Alternating 0 pds and prolene sutures were then placed through the fascia in multiple o'clock positions and the tails left long and tagged.The defect was then closed with #1 strata fix in a running fashion and there was no undue tension in doing so.A 10 x 15 cm oval piece of synecor mesh was then placed over the fascia and the previous pds and prolene sutures brought up through the mesh using a suture passer device again in the multiple o'clock positions.The sutures were tied down the mesh was noted to lie flat against the fascia without undue tension or torsion or kinking.The area was copiously irrigated and suctioned clear.We then proceeded with closure.A 19 french round fluted blake drain was placed on top of the mesh and brought to the left lower quadrant with stab incision.It was secured in place with a 2-0 nylon drain stitch.The subcutaneous fat was then reapproximated over the drain using interrupted 0 vicryl sutures.The deep dermal layer was reapproximated interrupted 3-0 vicryl sutures.The skin was re-approximate skin staples.In order to reduce seroma, hematoma, and infection risk, a prevena wound vac was applied.The purple sponge was cut to the appropriate fit and placed upon the incision and secured to the suction tubing to 125mmhg continuous suction with good seal and no leaks.Total wound vac area applied was greater than 50 cm2.After confirming twice that the needle, sponge, and instrument counts were correct, general anesthesia was terminated.Sterile dressings were applied, foley catheter was discontinued, and the patient was taken to recovery in stable condition.¿ ¿ (b)(6) 2019: (b)(6) medical center.Implant record.¿mesh surgical gore synecor preperitoneal biomaterial synecor oval l15 cm x w10 cm preperitoneal knit web.¿ model/cat no.: gkwv1015.Serial no: (b)(6).Laterality: midline.Area: abdomen.Action: implanted.Number used: 1.Manufacturer: wl gore and associates, inc.¿ (b)(6) 2019: (b)(6) medical center.Implant sticker: gore® synecor preperitoneal biomaterial.Ref: gkwv1015.Sn: (b)(6).Location: abdomen.Quantity: (b)(4).Manufacturer: gore.Expiration: 3/26/2022.¿ (b)(6) 2019: (b)(6).(b)(6), md.Pathology report.Specimen: hernia sac.History: ventral hernia with bowel obstruction.- diagnosis: soft tissue, ventral hernia, herniorrhaphy, membranous fibroadipose tissue, consistent with hernia sac; mesothelial hyperplasia and chronic inflammation; focal foreign body reaction.- gross examination: received in formalin in a container labeled with patient name and as "hernia sac".Membranous tissue maximal dimension: 10.1 cm.Attached fat: yes.Measurement: up to 13.5 cm.Embedded with this tissue on multiple fragments is a tan mesh-like material and focal green sutures.¿ (b)(6) 2019: (b)(6) medical center.(b)(6), do.Discharge summary.Discharge diagnoses: acute abdominal pain secondary to ventral hernia with acute bowel obstruction, status postop day 3 repair by dr.(b)(6).Hospital course: patient was admitted, she was seen by surgeon and taken directly to surgery for her incarcerated ventral hernia.She had a uneventful postop course, her diet was advanced, she was eating without any nausea and having bowel movements and walking the halls.She was deemed stable to go home today.Instructions: keep vac on for another 3 days, remove.Wear binder at all times.Jp drain will come out in office at dr.(b)(6) next week.No lifting more than 10 pounds for 3 months at minimum.Follow up with pcp, (b)(6), do, in 1-2 weeks.Follow up with dr.(b)(6) in 1-2 weeks.Relevant medical information: ¿ (b)(6) 2019: (b)(6) medical center.(b)(6), md.Radiology.Procedure: ultrasound guided needle placement.Complex appearing anterior midline abdominal wall fluid collection.Successful ultrasound -guided aspiration of 10 ml of thick, cloudy yellow fluid which was sent to laboratory for analysis.¿ (b)(6) 2019: (b)(6) medical center.(b)(6).Laboratory results.Abdominal fluid collection.Culture: rare growth staphylococcus aureus.Gram stain: moderate polymorphonuclear leukocytes.Resistant to penicillin and erythromycin.Partial explant preoperative complaints: ¿ (b)(6) 2020: (b)(6) medical center.(b)(6)i, do.Emergency department.¿patient is a 49 -year -old female who is status post hernia repair with mesh placement who presents to the er with drainage from her surgical wound onset about 2 days ago.Reports liquidy drainage [sic] increased pain and increased redness around the lower aspect of her scar.She reports she is had subjective fever body aches chills at home.Describes the pain is sharp and stabbing.No radiation.Associated nausea and vomiting.On physical exam patient has a opening at the bottom end of the surgical scar.There is some drainage from the wound.It is tender to palpation with some mild erythema around it.Is reviewed.She has mild elevation of her lactic acid.She has a elevated white blood cell count.Ct shows abscess.Dr.Chinakaul [sic] consulted and will see patient in the morning.Patient mid to the hospitalist on broad-spectrum antibiotics.¿ ¿ (b)(6) 2020: (b)(6) medical center.Mohammed (b)(6), md.Radiology.Ct scan.Impression: ventral hernia repair with mesh demonstrates a probable abscess superficial to the mesh, with extensive surrounding fat stranding.Anterior abdominal wall peripherally enhancing 5.6 x 1.8 x 7.9 cm fluid collection with extensive surrounding tat stranding is located anterior to an abdominal wall mesh.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), pa-c.History and physical.49 y.O.Female with a pmhx stated below presenting to hillcrest medical center with complaints of her surgical wound opening up.Patient states she had a cholecystectomy complicated by bowel obstruction.Patient underwent surgery and developed a ventral hernia.The hernia was repaired and then had to have her hernia revision with mesh placement in (b)(6)2019.Patient has since developed postoperative infection and has been on antibiotics.Patient states over the past 2 days she has noticed tenderness around wound site and began to notice purulent drainage.Patient states yesterday and area at the surgical site had burst open with fluid therefore she decided come to the emergency department for further evaluation.Ct scan of the abdomen and pelvis was obtained and showed a ventral hernia repair with mesh demonstrates a probable abscess superficial to the mesh, with extensive surrounding fat stranding.General surgery was consulted.Blood cultures were obtained and patient was placed on iv antibiotics.Hospitalist was notified for admission.¿ gi: soft, distended, purulent drainage noted from mid lower abdomen super pubic [sic] area.Assessment and plan: admit for abdominal wall abscess at site of surgical wound.General surgery has been consulted.Patient is tentatively scheduled for the or in the a.M.Will place patient on iv antibiotics vancomycin and cefepime.We will await results of blood cultures.Will obtain wound cultures of the drainage from abdominal surgical site.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.Indication: ¿mrs.(b)(6) is a 49-year-old caucasian lady well known previously to me.She presented acutely last summer with recurrent ventral hernia and is status post recurrent ventral herniorrhaphy with mesh by me via an open onlay approach in (b)(6) 2019.She was followed postoperatively in clinic and her course was complicated by postoperative seroma which underwent ir aspiration that was positive for mssa.Plans were for then formal ir drain placement but the patient did not follow through with this due to improvement in her symptoms.She then presented this week with the opening of a wound at the inferior apex of her well-healed incision and ct imaging suggested abscess but showed no recurrence of hernia.She was taken to the operating room for formal incision and drainage and debridement, possible mesh explantation.¿ partial explant procedure: incision and drainage, complicated, abdominal wall abscess.Excisional debridement, subcutaneous tissues, 84 cm2.Explantation of hernia mesh.Wound vac placement greater than 50 cm2.Partial explant date: (b)(6)2020 (hospitalization dates (b)(6) 2020).¿ (b)(6) 2020: (b)(6) medical center.(b)(6), md.Operative report.Assistant: (b)(6), cfa.Preoperative and postoperative diagnosis: infected postoperative seroma/ abdominal wall abscess.Anesthesia: general.Estimated blood loss: 5 ml.Specimens: wound swab for gram stain, culture, and sensitivity.Hernia mesh.Complications: none.¿ wound class: clean contaminated.¿ findings: ¿large approximately 14 x 6 cm seroma cavity within the midline abdominal wall superior to previous hernia mesh.This contained a large amount of just slightly cloudy tan serous type fluid, swabs which were taken and sent for gram stain, culture, and sensitivity.No gross purulence.Previous hernia mesh appeared very well incorporated essentially with only small portions of bare exposed mesh at the periphery which were explanted excisionally.A large amount of fibrinous exudate and sinus granulation was also excisionally debrided with a sharp curette.Wound vac placed for coverage.¿ ¿ procedure: ¿informed consent was obtained preoperatively in which the risks benefits and alternatives to the planned procedure were explained at length to the patient and/or guardian who expressed understanding and wished to proceed.On the day of the procedure the patient was correctly identified in the holding area and then brought back and placed supine on operating room table.Sequential compression devices were placed, the patient was already on therapeutic preoperative antibiotics, and after adequate anesthesia was obtained, the patient's abdomen was prepped and draped in the usual sterile fashion.First the patient's previous well-healed midline incision was infiltrated with local anesthetic.Incision was then performed with a scalpel starting at the small less than 1 cm round wound at the inferior apex and extended upwards around the umbilicus.Dissection was carried down through the subcutaneous fat with electrocautery entering the seroma cavity which contained a large amount of just slightly cloudy almost clear tan fluid, swabs which were taken and sent for gram stain, culture, and sensitivity.The seroma cavity was then opened for the length of skin incision and was found to measure 14 x 6 cm in size.There was a large amount of fibrinous exudate and sinus granulation but no gross purulence or necrotic tissue.The mesh appeared to be well incorporated centrally with only small edges of exposed bare mesh.This along with some prolene suture were cut with the curved mayo scissors and passed off for gross pathology.Then using a sharp curette, the nonviable exudate and chronic sinus granulation was excisionally debrided on the order of 84 cm2.Once complete there was no exposed bare mesh or other foreign bodies.The wound base was pink and as noted above previous mesh was well incorporated not visible and there was no evidence of recurrence of hernia.The wound was then copiously irrigated with betadine containing saline and suctioned clear.Given the above changes i elected to obtain closure with the wound vac device.The black granufoam sponge was cut to the appropriate fit and placed within the wound followed by the plastic adhesive drapes and suction tubing to 125 mmhg continuous suction with good seal and no leaks.Total wound vac area applied was greater than 50 cm2.After confirming twice that the needle, sponge, and instrument counts were correct, general anesthesia was terminated.Sterile dressings were applied and the patient was taken to recovery in stable condition.¿ ¿ (b)(6) 2020: (b)(6).(b)(6), md.Pathology report.Specimen: hernia mesh.History: abdominal wall abscess at site of surgical wound.- diagnosis: prosthesis, mesh, excision multiple fragments of synthetic mesh and suture; no soft tissue is present (gross diagnosis).- gross examination: received in formalin in a container labeled with the patient's name and "hernia mesh" are multiple irregularly shaped fragments of tan synthetic mesh which measure 2.5 x 1.1 x 0.7 cm in aggregate.Also, present is a small segment of suturing.The specimen is submitted for gross examination only.No sections are taken for histologic examination.¿ (b)(6) 2020: (b)(6) medical center.(b)(6), aprn-cnp.Discharge summary.Hospital course: 49 y.O.Female who presented for evaluation of abdominal wall abscess at site of surgical wound.Per general surgery, seroma developed into abscess and she underwent ir guided aspiration with mssa positive culture in (b)(6) 2019.Patient now presents with opening of the seroma and drainage and abscess.General surgery performed for formal incision and drainage and wound vac placement.Discharged home to continue wound vac and follow-up general surgery outpatient.Continue iv antibiotics x2 weeks and then switch to keflex for another 2 weeks.Infectious disease.Follow-up with id.Condition: good.Discharged to home with home health. see attachment.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® synecor® preperitoneal 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® synecor® preperitoneal 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.
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Additional Manufacturer Narrative
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H6: conclusion code remains unchanged.It should be noted that the gore® synecor® preperitoneal 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® synecor® preperitoneal 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.
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Additional Manufacturer Narrative
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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.It should be noted that the gore® synecor preperitoneal 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, pain, exposure (extrusion), bowel obstruction and recurrence.As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿ the instructions for use further warn: ¿when post-operative infection is suspected, debridement of involved tissues should be considered.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.Individual medical decisions and/or actions of healthcare professional or device user, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.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.A portion of the device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Based upon the information received, part of the device remains in the patient and was not available for evaluation.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.
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