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| Model Number 1DLMCP08 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)
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| Event Date 01/24/2012 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2010 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2012, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: small bowel obstruction, pain, mesh removal, additional surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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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: (b)(6) 2013: office notes.Hpi: two previous hernias repaired, umbilical, incisional; now with recurrent incisional hernia.Bulge supraumbilical midline last 2 months.Pmh: diabetes.Psh: open appendectomy, umbilical hernia repair, ventral hernia repair.Exam: reducible incisional hernia mid epigastric area.Impression: asymptomatic reducible incisional hernia.Plan: incisional hernia repair.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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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: records prior to (b)(6) 2009, including records for the ¿status post repair of ventral hernia, repair of umbilical hernia¿ noted in the (b)(6) 2009 records, were not provided.Additionally, product identification records for the ¿mesh from prior repair¿ noted in the (b)(6) 2010 records were not provided.Records dated (b)(6) 2009 state: ¿57yearold gentleman who volunteers that he has known of the ventral hernia for about 1 ½ years.The hernia was asymptomatic until about 1 ½ weeks ago when he presented to the emergency room with associated pain.Patient also notes occasional loose, watery bowel movements.¿ ¿he volunteers about a 10packyear smoking history.¿ ¿patient is status post repair of ventral hernia, repair of umbilical hernia, surgery to the right shoulder, nasal surgery, tonsillectomy.Radiologic studies indicate the patient has had a cholecystectomy.¿ exam notes state: ¿there is some right subcostal scar.In the mid portion of the scar is a defect measuring about 8 to 10 cm with protrusion measuring about 15 cm.There is also an infraumbilical scar.There is incarcerated umbilical hernia with protrusion measuring about 5 cm.¿ ¿abdominal exam reveals a recurrent ventral hernia in the supraumbilical region.The defect measures about 15 cm.It is reducible.It is nontender.¿ operative records dated (b)(6) 2010 indicate the patient underwent ¿laparoscopic repair of recurrent incarcerated ventral incisional hernia with goretex dualmesh.¿ ¿the patient is a 58yearold gentleman with a recurrent ventral incisional hernia, predominantly in the periumbilical region, as well as to the right of midline.¿ the (b)(6) 2010 operative report states: ¿a stab incision was made in the left subcostal region and with tenting of the anterior abdominal wall veress needle was placed, insufflation was accomplished.The scope was passed after placement of a 5 mm trocar.Under direct camera vision eventual respective 5 mm left lower quadrant, 5 mm right lower quadrant, and 12 mm right lateral midabdominal trocars were placed.Omentum was noted adherent to the anterior abdominal wall hernia and there were multiple loculations with entrapment of omentum.The entrapment was reduced uneventfully, and the area of defect was at least 18 cm in greatest diameter with multiple pockets noted.One of the pockets was noted to contain mesh from prior repair.Following reduction, hemostasis was insured.A 26 x 34cm goretex dualmesh was then passed intraabdominally with the cutting points being matched.The mesh was then brought up to the anterior abdominal wall within the abdominal cavity with the smoothed not inherent surface facing the viscous.It was tacked at cardinal points and vicryl sutures were anchored.¿ records regarding the ¿mesh from prior repair¿ were not provided.The (b)(6) 2010 operative report does not indicate removal of the ¿mesh from prior repair.¿ the (b)(6) 2010 operative records continue: ¿circumferential tacking was then used using origin tackers.The repair was noted to be firm and allowed a distance of at least 4 cm beyond the margins of all defects.Hemostasis was ensured.Co2 was allowed to egress from the abdominal cavity.The fascia at the 12 mm trocar site was approximated closed with vicryl stitch.Subcu and subdermal approximation at respective stab sites was with vicryl interrupted stitches.Skin was approximated with subcuticular vicryl stitches.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp08/7309658) was implanted during the procedure.Discharge summary records dated (b)(6) 2010 indicate the patient was admitted to the hospital on (b)(6) 2010.¿this patient is a 58yearold african american male who came to the emergency room complaining of abdominal pain, distention and vomiting.The patient stated that he underwent a repair of laparoscopic ventral hernia on (b)(6) 2010.He stated that he went home and he noted progressive swelling in his abdomen with increasing pain.He had been vomiting several times, yellowish greenish material.He has not had a bowel movement since his prior surgery.He admitted to passing small amounts of flatus.He fever or chills.The patient was admitted for small bowel obstruction versus ileus, status post recurrent ventral hernia repair.¿ records dated (b)(6) 2010 indicate a ct scan of the chest, abdomen and pelvis was performed.¿the patient is status post cholecystectomy.There is evidence of abdominal surgery with metal staples in the anterior abdominal wall.This may be recent surgery as there are postoperative changes in the subcutaneous fat of the anterior abdominal wall.There are also several small gas bubbles in the anterior abdominal wall.There are 2 loculated fluid collections in the anterior abdominal wall just above the umbilicus.There is a penile prosthesis with a reservoir in the extreme right lower quadrant.There is diffuse fluid distention of the small bowel with a transition point¿in the very distal small bowel.The colon is decompressed relative to the caliber of the distended small bowel.There are bullous changes in the upper lobes.There is some apparent interstitial lung disease present.¿ impression from the (b)(6) 2010 ct states: ¿there is presumptive evidence of recent abdominal surgery with postoperative changes in the subcutaneous fat of the anterior abdominal wall.There are 2 encapsulated fluid collections in the anterior abdominal wall.These could represent seromas or abscesses.Clinical correlation in this regard is essential.¿ ¿there is a distal small bowel obstruction.¿ the (b)(6) 2010 discharge summary states: ¿a ct scan of the abdomen and pelvis was obtained which showed that the patient had a distal small bowel obstruction and basilar atelectasis.An ng tube was placed which immediately began draining green, bile-like secretions, totaling greater than 600 ml, and the patient also had an episode where he was feeling short of breath.A v/q scan was done and results were low probability for a pe.A venti mask was placed and a pulmonary consult was obtained¿a renal consult was also obtained¿for his acute renal insufficiency.The patient continued to be treated with iv fluids, antibiotics, and maintained an n.P.O.Status with ng tube placement for decompression.¿ the (b)(6) 2010 discharge summary continues: ¿on (b)(6) 2010 the patient reported having 2 bms that morning.He did not know if he had vomiting or shortness of breath.At that time the ng tube was removed and the patient was started on a clear liquid diet.Followup chest xray was done which was unremarkable.The patient¿s diet was advanced to a regular 4 gm sodium diabetic diet which the patient tolerated.The patient is able to be discharged today.¿ discharge diagnoses are noted as small bowel obstruction, status post laparoscopic ventral hernia repair from previous admission, bibasilar atelectasis, acute renal insufficiency, urinary tract infection, history of diabetes mellitus, and history of hypertension.Records between (b)(6) 2010 and (b)(6) 2011 were not provided.Records dated (b)(6) 2011 state a ct of the abdomen and pelvis was performed.¿history: abdominal wound, infection, question of abscess.¿ ¿there are chronic changes in the anterior abdominal wall related to prior hernia repair.Just deep to the anterior abdominal wall, there is a 19cm fluid collection.The collection is surrounded by surgical clips anteriorly and it could represent a seroma.The bowel loops are unremarkable.No herniation of bowel is seen.¿ ¿impression: a 19cm fluid collection in the anterior abdomen just deep to the anterior abdominal wall may be compatible with a seroma.It is in the region of previous hernia repair.Changes in the anterior abdominal wall with stranding in the subcutaneous soft tissue may be postsurgical scarring.Status post cholecystectomy.No obstruction or free air¿¿ records dated (b)(6) 2011 state a ct of the abdomen and pelvis was performed.¿history: recurrent abdominal wall hernia.¿ct examination was compared directly to a previous examination performed on (b)(6) 2011.The large seroma noted in the anterior mid abdomen on the previous study has resolved.There is a recurrent ventral abdominal wall hernia.It is just above the level of the umbilicus.It has a width of approximately 6.4 cm, a depth of approximately 2.8 cm and extends for approximately 8 cm in length.In the upper twothirds, primarily fat within this hernia.There is minimal small bowel noted in the lower portion of this hernia.There is no evidence of small bowel obstruction.¿ records dated (b)(6) 2012 state the patient ¿¿comes to the office today for followup visit today.He offers no significant complains [sic].Abdominal exam is unchanged.Ct confirms the presence of a large ventral hernia.It appears immediately supra umbilical.Patient will be scheduled for repair.He has been advised that umbilical excision might be necessary.¿ operative records dated (b)(6) 2012 state the patient underwent ¿repair of recurrent ventral incisional hernia with excision of overlying skin and underlying mesh.¿ the records state: ¿an elliptical incision, staying superior to the umbilicus, was made.Incision measured about 20 cm in vertical orientation.The ellipse was carried about the scar, carried through the skin and subcutaneous to underlying mesh, and a portion of mesh was excised that was involved within the hernia sac itself.A good rim was then noted circumferentially inclusive of mesh.Metallic tacks in the immediate surgical area were removed with kocher clamps.Hemostasis was ensured.A singlelayer closure was then undertaken with looped pds running stitch.¿ the records indicate a portion of a mesh device was removed during the procedure.It is unclear from the records which mesh was partially removed during the procedure.Records dated (b)(6) 2012 state: ¿patient had a ventral hernia repair done (b)(6) 2009 when he presented with an incarceration.Patient presents to the hospital again today with recurrence of his ventral hernia.Patient was taken to the recovery room postoperatively and extubated but then developed a respiratory distress and was reintubated.Chest xray afterwards shows the patient to have bilateral vascular congestion and it is hypoinflated film.Patient was given approximately 2.5 liters of fluid during and postoperatively.Patient was referred to the icu because of failed ability to extubate patient postoperatively.¿ a pathology report dated (b)(6) 2012 regarding a specimen collected (b)(6) 2012 states: ¿specimen: a.Hernia sac.Gross description: a.Received in formalin¿ it consists of a 10.0 x 5.8 x 2.2 cm, brown skin ellipse.The skin surface is remarkable for a 5.0 cm in length, well healed linear scar.The subcutaneous tissue is membranous and remarkable for two coiled wires.¿ ¿diagnosis: a.Ventral hernia repair: skin with scar and hernia sac with foreign-body reaction.¿ the pathology report does mention information regarding the mesh partially removed on (b)(6) 2012.Records between 1/26/2012 and 10/4/2013 were not provided.Operative records dated (b)(6) 2013 indicate the patient underwent ¿open repair of recurrent incisional hernia with an underlay ventralex mesh.¿ the records state: ¿a 15 blade was used to excise the old midepigastric scar.The length of the scar was about 12 cm in length and 1 cm in width.This was done using a 15 blade.We then used electrocautery to slowly sharply dissect down into the subcutaneous tissue.We entered preperitoneal space without incident.The bowel was slowly taken off of the anterior abdominal wall adhesions.This was done slowly and meticulously with metzenbaum scissors.Eventually we were able to free all the adhesions to the anterior abdominal wall in the preperitoneal space.The patient had a defect of approximately 5 cm x 5 cm.A piece of ventralex mesh was then used for the underlay repair.The mesh itself is inset in an underlay fashion with multiple 1 prolene stitches.The mesh was laid down tightly and flatly without any undue tension.Irrigation was performed.Hemostasis was achieved with electrocautery.The incision was closed with running 20 vicryl for the deep tissue layer, interrupted 30 vicryl for the dermal layer and the skin was closed using staples.¿ the records confirm a bard ventralex (nongore device) was implanted during the procedure.There was no mention of the gore device in the records and no mention of device removal.Records between (b)(6) 2013 and (b)(6) 2015 were not provided.Records dated (b)(6) 2015 state the patient was seen for follow up.¿this is a 63yearold gentleman who was seen by me about two years ago for a midepigastric incisional hernia.He underwent an underlay ventralex mesh repair.He has been doing well.Over the last few months, he noticed some fullness to the right lower abdominal wall area just to the right at the midline.There was been no fever, chills, nausea, vomiting.Overall, he feels well.He is not sure if he does have a recurrence hernia.He is an obese gentleman with diabetes and high blood pressure.¿ ¿he has only mild discomfort to the area.There is no palpable subcutaneous bulges or masses.¿ past surgical history states: ¿open appendectomy as a child through a midline incision, umbilical hernia repair and ventral hernia repair x 2.¿ the (b)(6) 2015 records state: ¿abdomen: soft, distended.He has a long scar in the midline.No cellulitis.No open wound.The right lower paramedian area seems fuller compared to the left side but due to his body habitus it is hard to determine if this is a hernia.It is mildly tender.No open wound.No masses.¿ ¿the plan is to get a ct scan of his abdomen and pelvis for further evaluation.Should he have a recurrent hernia, i would recommend repairing.I also encouraged him to lose some weight that might help with his high blood pressure and diabetes.¿ ct scan records dated (b)(6) 2015 state: ¿the patient is status post previous ventral hernia repair in the upper abdomen.Widemouth ventral hernia in the upper abdomen contains fat and nonobstructed small and large bowel.The hernia defect measures 8.7 cm in transverse and 8.8 cm in craniocaudal dimensions.There is also been prior umbilical hernia repair without evidence of a recurrent umbilical hernia.No hernia is identified in the lower anterior abdominal wall.¿ operative records dated (b)(6) 2015 state the patient underwent ¿open repair of chronically incarcerated incisional hernia with an inlay composite polyester mesh.¿ the records state: ¿a #15 blade was used to excise this scar.Electrocautery then was used to carry the incision down slowly to the abdominal wall fascia.We immediately encountered the hernia sac.Sac was entered.There was moderate amount of omentum and small bowel inside the sac itself.This was slowly lysed from the sac.The sac then was fully dissected out of the subcutaneous tissue and excised along the fascial edges.He did have very attenuated fascia, but there was fortunately minimal adhesion to the anterior abdominal wall.After this was sac was excised, the fascial defect is measured to be approximately 8 x 8 cm.A composite polyester mesh was used for the repair.It was inset in an inlay fashion with running #1 prolene.¿ the (b)(6) 2015 operative report states: ¿there was just adequate tension on the mesh to allow it to be nicely laid down flat without too much tension to the abdominal wall.A #15french solid round silicone drain was placed on top of the mesh and brought out through the right side of the incision.The midline incision was closed with running 20 vicryl deep tissue layer, interrupted 30 vicryl for the dermal layer, and the skin was reapproximated using staples.¿ there was no mention of the gore device in the records and no mention of device removal.A pathology report dated (b)(6) 2015 regarding a specimen collected (b)(6) 2015 states: ¿pathologic diagnosis: hernia sac, incisional hernia repair mesothelial lined fibroadipose tissue with focal necrosis of fat, submesothelial fibrosis, vascular congestion and focal hemorrhage compatible with the clinical history of recurrent incarcerated incisional hernia.¿ ¿gross description: the specimen is received in formalin, labeled with¿¿hernia sac¿ and consists of a strip of pink to yellowtan fibroadipose tissue that is 6.2 x 1.2 x 0.4 cm.Sectioning reveals no discrete masses or indurated areas.¿ records dated (b)(6) 2015 state: ¿63 [year old] male with pulmonary embolism, [status post] incisional hernia repair, [acute kidney injury].[acute kidney injury] may be due to hypovolemia with some additional contribution from radiocontrast nephropathy.In addition, patient has a significant ileus.¿ ct scan records dated (b)(6) 2015 state: ¿post surgical changes, status post recent ventral abdominal wall hernia repair.Hematoma within the overlying subcutaneous soft tissues measures 17.0 x 5.4 x 5.8 cm and contains a surgical drain.Mild diastases of the ventral abdominal wall just superior to the hernia repair where a loop of small and large bowel partially extends into the area of diastases without definite resulting obstruction.Multiple abnormally dilated loops of small bowel throughout the abdomen are noted without definite highgrade transition point identified.Findings may be on the basis of postoperative ileus.¿ operative records dated (b)(6) 2015 state the patient underwent evacuation and washout of a subcutaneous hematoma following incisional hernia repair.¿this is a 63yearold gentleman with recurrent incarcerated incisional hernia repair who underwent an inlay repair about five days ago.Postoperatively, he developed a pulmonary embolus.He has been on anticoagulation.He developed a large hematoma in the subcutaneous tissue above the mesh as the hematoma itself is impressive in size.He has some additional discomfort from this, which leads to some compromise in his respirations due to the size of the hematoma, he was symptomatic from it, and the fact that there was concern that this could develop into an infection right above the mass, i decided to come back for washout.¿ the (b)(6) 2015 operative report states: ¿the staple along the midline was removed.We immediately encountered a large pocket of mixed clotted and liquefied hematoma.This was all evacuated.The mesh repair is intact.No evidence of any dehiscence or hernia recurrence.¿ ¿the incision was closed with running 20 vicryl for the dermal layer and staples for the skin layer.¿ addendum notes dated (b)(6) 2015 state: ¿patient status: remains critically ill.¿ ¿interval history: patient is a 63 yearold aa male with history of [noninsulin dependent diabetes mellitus] and [hypertension] who is [postoperative day] #5 inguinal hernia repair that was complicated by a perioperative [pulmonary embolism], [acute kidney injury], ileus, and hematoma.[postoperative day] #1 evacuation and washout of abdominal hematoma following incisional hernia repair.¿ abdominal exam notes state: ¿abdomen round, slightly distended, and nontender.Positive bowel sounds.Liquid stool.Surgical site clean and intact.Jp drain x1 with serosanguineous output.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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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: 08/12/10: total health care ¿ linden pediatrics.Tahani williams.Office notes.Cc: pre-op physical.Says having ventral hernia repair august 19 at bon secour hospital with universal surgical assoc.No new concerns today.Current smoker; #20 per day.Wt.192 lbs., bmi 30.Diabetes.Stable for surgery.Records between (b)(6) 2010 and (b)(6) 2011 were not provided.(b)(6) 2011: (b)(6) md.Office notes.Cc: pre-op for i&d of seroma on abdominal wall.Scheduled for 7/15.Pt is s/p multiple vah repair in past.C/o pain along incision.Mri revealed seroma.(b)(6) 2011: [missing records: records for the i&d of seroma on abdominal wall were not provided] (b)(6) 2011: (b)(6) health care ¿ westside.(b)(6) md.Office notes.Cc: f/u.Recently had drain removed from abdomen.Drain was placed to treat abdominal seroma.Pt denies abdominal swelling.C/o mild pain.Wt.186.(b)(6) 2011: (b)(6) health care(b)(6) md.Office notes.Cc: diabetic f/u.H/o abdominal infection ¿ s/p removal of infected mesh.Wound vac started.Wt.189 lbs.Bmi 28.84.Assessment: diabetes type ii, uncontrolled.Seroma: continue wound vac, f/u with general surgery next week.(b)(6) 2011: (b)(6) surgical associates.(b)(6) md.Office notes.Pt noted to have abdominal wall protrusion, denies pain.Exam reveals a recurrent ventral hernia in the supraumbilical region, measures 15 cm.It is reducible, non-tender.Pt scheduled for ct of the abdomen.F/u 1 month, call with associated symptoms.(b)(6) 2012: (b)(6) health care, p.C.[illegible signature].Office notes.Hpi: hx of dm, htn; present for pre-op for ventral hernia repair.Smokes 1 ppd ¿ 20 years.Wt.195 lbs., ht 5¿8.(b)(6) 2012: (b)(6) hospital center.(b)(6) pa.Discharge instructions.Home meds included aspirin, glipizide, and metformin.Follow up appointment: call dr.(b)(6) in 1-2 weeks.Make appt with primary medical doctor next week for high blood pressure and diabetes evaluation.Notify physician: worsening symptoms, other: shortness of breath, nausea, vomiting, abd pain not relieved by percocet.Return to work/school: after cleared by dr.(b)(6).Diet: low carb, residue and sodium.Activities restricted: no driving, heavy lifting, smoking; eliminate or reduce consumption of alcohol.Length of time for driving restriction: while on pain medication.Specific lifting restrictions: no lifting greater than 10 lbs.Activities encouraged: activity as tolerated, rest when tired, short of breath, or if chest pain occurs, use incentive spirometry 10 times per hour while awake, cough and deep breath to increase your oxygen, stop smoking.Dressings/wound care: may remove dressing in 24-48 hours.Dressing instructions/details: use dry sterile dressings with take once daily, keep incision dry, use abd.Binder at all times, notify surgeon if increased drainage occurs.(b)(6) 2012: (b)(6) hospital center.(b)(6) md.Discharge summary report.Admission diagnosis: recurrent ventral hernia.Discharge diagnosis: recurrent ventral hernia, congestive failure.Hospital course: admitted to undergo elective repair of ventral incisional hernia.Patients procedure was uneventful.He had problems with extubation, the tube was left in place.Per cardiologist patient is stable at this time.Exam: abdomen is soft and postoperative tender.Wound is clean.Meds at discharge: percocet.Special instructions: he is to call with severe abdominal pain, nausea.Or vomiting.Activity: his activities are to be light.No significant straining or driving.(b)(6) 2012: (b)(6) health care ¿(b)(6) md.Cc: f/u diabetes.Approx.3 weeks s/p ventral hernia repair, uncomplicated; has surgery f/u (b)(6) 2012.Diabetes controlled.(b)(6) 2012: total health care ¿ westside.Viet nguyen, do.Office notes.Hpi: pre-op evaluation for repair of recurrent ventral hernia pending medical clearance.Had ventral hernia repair in early 2010 without complications.Wt.194.Blood pressure poorly controlled.Random blood glucose 212.(b)(6) 2013: (b)(6) health care (b)(6) office notes.Hpi: needs referral to see surgeon for hernia.C/o recurrent ventral hernia for 1 month.Order: referral surgery.(b)(6) 2013: (b)(6) health care.(b)(6) office notes.Hpi: f/u; had successful incisional repair surgery.(b)(6) 2015: (b)(6) family practice.(b)(6) office notes.Cc: f/u hernia repair and blood clot in lungs.Meds [included] aspirin, glipizide, humalog, xarelto.On insulin pump.Surgical history: ventral hernia repair x 6 times last being (b)(6) 2015, appendectomy, cholecystectomy.Current every day smoker.Assessment/plan: ventral incisional hernia s/p repair complicated by post op pe; healing well.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Previous patient codes (1994, 2422) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span (b)(6) 2009 through (b)(6), 2015 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from (b)(6), 2010 through (b)(6), 2011; from (b)(6), 2013 through (b)(6), 2015 were not provided.Patient information: medical history: diabetes, obesity, (b)(6) 2009: 192 lbs; bmi 30, smoking, 1 pack/day x 40 years, prior surgical procedures: 1996: umbilical hernia repair ¿ 2009: recurrent ventral hernia repair, cholecystectomy relevant medical information: ¿ (b)(6) 2009: ¿57-year-old gentleman who volunteers that he has known of the ventral hernia for about 1 ½ years.The hernia was asymptomatic until about 1 ½ weeks ago when he presented to the emergency room with associated pain.Patient also notes occasional loose, watery bowel movements.¿ ¿he volunteers about a 10-pack-year smoking history.¿ ¿patient is status post repair of ventral hernia, repair of umbilical hernia, surgery to the right shoulder, nasal surgery, tonsillectomy.Radiologic studies indicate the patient has had a cholecystectomy.¿ ¿there is some right subcostal scar.In the mid portion of the scar is a defect measuring about 8 to 10 cm with protrusion measuring about 15 cm.There is also an infraumbilical scar.There is incarcerated umbilical hernia with protrusion measuring about 5 cm.¿ ¿abdominal exam reveals a recurrent ventral hernia in the supraumbilical region.The defect measures about 15 cm.It is reducible.It is nontender.¿ implant preoperative complaints: ¿ (b)(6) 2010: ¿the patient is a 58-year-old gentleman with a recurrent ventral incisional hernia, predominantly in the periumbilical region, as well as to the right of midline.¿ implant procedure: laparoscopic repair of recurrent incarcerated ventral incisional hernia with ¿gore-tex dualmesh¿.Implant: gore® dualmesh® plus biomaterial (7309658/1dlmcp08) 26 x 34 cm, oval.Implant date: (b)(6) 2010 description of hernia being treated: ¿a stab incision was made in the left subcostal region and with tenting of the anterior abdominal wall veress needle was placed, insufflation was accomplished.The scope was passed after placement of a 5 mm trocar.Under direct camera vision eventual respective 5 mm left lower quadrant, 5 mm right lower quadrant, and 12 mm right lateral midabdominal trocars were placed.Omentum was noted adherent to the anterior abdominal wall hernia and there were multiple loculations with entrapment of omentum.The entrapment was reduced uneventfully, and the area of defect was at least 18 cm in greatest diameter with multiple pockets noted.One of the pockets was noted to contain mesh from prior repair.Following reduction, hemostasis was insured.¿ implant size and fixation: ¿a 26 x 34-cm gore-tex dualmesh was then passed intra-abdominally with the cutting points being matched.The mesh was then brought up to the anterior abdominal wall within the abdominal cavity with the smoothed ¿not inherent [sic] surface ¿facing the viscous.It was tacked at cardinal points and vicryl sutures were anchored.Circumferential tacking was then used using origin tackers.The repair was noted to be firm and allowed a distance of at least 4 cm beyond the margins of all defects.Hemostasis was ensured.Co2 was allowed to egress from the abdominal cavity.The fascia at the 12 mm trocar site was approximated closed with vicryl stitch.Subcu [subcutaneous] and subdermal approximation at respective stab sites was with vicryl interrupted stitches.Skin was approximated with subcuticular vicryl stitches.¿ no post-operative records were provided.Relevant medical information: hospitalization (b)(6), 2010 (b)(6) 2010: ct abdomen/pelvis: ¿there is presumptive evidence of recent abdominal surgery with postoperative changes in the subcutaneous fat of the anterior abdominal wall.There are 2 encapsulated fluid collections in the anterior abdominal wall.These could represent seromas or abscesses.Clinical correlation in this regard is essential.¿ ¿there is a distal small bowel obstruction.¿ (b)(6) 2010: discharge summary: ¿this patient is a 58-year-old african american male who came to the emergency room complaining of abdominal pain, distention and vomiting.The patient stated that he underwent a repair of laparoscopic ventral hernia on (b)(6) 2010.He stated that he went home and he noted progressive swelling in his abdomen with increasing pain.He had been vomiting several times, yellowish-greenish material.He has not had a bowel movement since his prior surgery.He admitted to passing small amounts of flatus.He fever or chills.The patient was admitted for small bowel obstruction versus ileus, status post recurrent ventral hernia repair.¿ ¿a ct scan of the abdomen and pelvis was obtained which showed that the patient had a distal small bowel obstruction and basilar atelectasis.An ng [nasogastric] tube was placed which immediately began draining green, bile-like secretions, totaling greater than 600 ml, and the patient also had an episode where he was feeling short of breath.A v/q [ventilation/perfusion] scan was done and results were low probability for a pe [pulmonary embolism].A venti mask was placed and a pulmonary consult was obtained.A renal consult was also obtained.For his acute renal insufficiency.The patient continued to be treated with iv fluids, antibiotics, and maintained an n.P.O.[nothing by mouth] status with ng tube placement for decompression.¿ ¿on (b)(6) 2010 the patient reported having 2 bms that morning.He did not know if he had vomiting or shortness of breath.At that time the ng tube was removed and the patient was started on a clear liquid diet.Followup chest x-ray was done which was unremarkable.The patient¿s diet was advanced to a regular 4 gm sodium diabetic diet which the patient tolerated.The patient is able to be discharged today.¿ ¿ (b)(6) 2011: pre-op for i&d [incision and drainage] of seroma on abdominal wall.Scheduled for (b)(6).Pt is s/p [status post] multiple vah [ventral abdominal hernia] repair in past.C/o [complains of] pain along incision.Mri revealed seroma.¿ record of the i&d of an abdominal wall seroma performed on 7/15/11 was not provided.¿ (b)(6) 2011: recently had drain removed from abdomen.Drain was placed to treat abdominal seroma.Pt denies abdominal swelling.C/o mild pain.¿ (b)(6) 2011: ct abdomen/pelvis: ¿impression: 1.A 19-cm fluid collection in the anterior abdomen just deep to the anterior abdominal wall may be compatible with a seroma.It is in the region of previous hernia repair.2.Changes in the anterior abdominal wall with stranding in the subcutaneous soft tissue may be postsurgical scarring.3.Status post cholecystectomy.4.No obstruction or free air.¿ ¿ (b)(6) 2011: ¿h/o [history of] abdominal infection ¿s/p removal of infected mesh.Wound vac started.¿ [operative records for ¿removal of infected mesh¿ were not provided.] explant preoperative complaints: ¿ (b)(6) 2011: ¿pt noted to have abdominal wall protrusion, denies pain.Exam reveals a recurrent ventral hernia in the supraumbilical region, measures 15 cm.It is reducible, non-tender.Pt scheduled for ct of the abdomen.¿ ¿ (b)(6) 2011: ct abdomen/pelvis: ¿the large seroma noted in the anterior mid abdomen on the previous study has resolved.There is a recurrent ventral abdominal wall hernia.It is just above the level of the umbilicus.It has a width of approximately 6.4 cm, a depth of approximately 2.8 cm and extends for approximately 8 cm in length.In the upper two-thirds, primarily fat within this hernia.There is minimal small bowel noted in the lower portion of this hernia.There is no evidence of small bowel obstruction.¿ ¿ (b)(6) 2012: ¿.Comes to the office today for followup visit today.He offers no significant complains [sic].Abdominal exam is unchanged.Ct confirms the presence of a large ventral hernia.It appears immediately supra umbilical.Patient will be scheduled for repair.He has been advised that umbilical excision might be necessary.¿ explant procedure: repair of recurrent ventral incisional hernia with excision of overlying skin and underlying mesh.Explant date: (b)(6), 2012 ¿an elliptical incision, staying superior to the umbilicus, was made.Incision measured about 20 cm in vertical orientation.The ellipse was carried about the scar, carried through the skin and subcutaneous to underlying mesh, and a portion of mesh was excised that was involved within the hernia sac itself.A good rim was then noted circumferentially inclusive of mesh.Metallic tacks in the immediate surgical area were removed with kocher clamps.Hemostasis was ensured.A single-layer closure was then undertaken with looped pds running stitch.¿ relevant medical information: (b)(6) 2012: ¿patient had a ventral hernia repair done (b)(6) 2009 when he presented with an incarceration.Patient presents to the hospital again today with recurrence of his ventral hernia.Patient was taken to the recovery room postoperatively and extubated but then developed a respiratory distress and was reintubated.Chest x-ray afterwards shows the patient to have bilateral vascular congestion and it is hypoinflated film.Patient was given approximately 2.5 liters of fluid during and postoperatively.Patient was referred to the icu because of failed ability to extubate patient postoperatively.¿ pathology report from (b)(6) 2012 regarding specimens collected during the (b)(6) 2012 procedure did not include references to the ¿portion of mesh¿ excised during the procedure.(b)(6) 2012: ¿admitted to undergo elective repair of ventral incisional hernia.Patients procedure was uneventful.He had problems with extubation, the tube was left in place.Per cardiologist patient is stable at this time.Exam: abdomen is soft and postoperative tender.Wound is clean.¿ (b)(6) 2012: ¿pre-op evaluation for repair of recurrent ventral hernia pending medical clearance.Had ventral hernia repair in early 2010 without complications.¿ (b)(6) 2013: ¿needs referral to see surgeon for hernia.C/o recurrent ventral hernia for 1 month.¿ (b)(6) 2013: ¿exam: reducible incisional hernia mid epigastric area.Impression: asymptomatic reducible incisional hernia.¿ (b)(6) 2013: open repair of recurrent incisional hernia with an underlay ventralex mesh ¿a 15 blade was used to excise the old midepigastric scar.The length of the scar was about 12 cm in length and 1 cm in width.This was done using a 15 blade.We then used electrocautery to slowly sharply dissect down into the subcutaneous tissue.We entered preperitoneal space without incident.The bowel was slowly taken off of the anterior abdominal wall adhesions.This was done slowly and meticulously with metzenbaum scissors.Eventually we were able to free all the adhesions to the anterior abdominal wall in the preperitoneal space.The patient had a defect of approximately 5 cm x 5 cm.A piece of ventralex mesh was then used for the underlay repair.The mesh itself is inset in an underlay fashion with multiple 1 prolene stitches.The mesh was laid down tightly and flatly without any undue tension.Irrigation was performed.Hemostasis was achieved with electrocautery.The incision was closed with running 2-0 vicryl for the deep tissue layer, interrupted 3-0 vicryl for the dermal layer and the skin was closed using staples.¿ the (b)(6) 2013 operative record does not mention the previously placed and partially excised mesh.(b)(6) 2013: ¿f/u[follow up]; had successful incisional repair surgery.¿ (b)(6) 2015: ¿this is a 63-year-old gentleman who was seen by me about two years ago for a midepigastric incisional hernia.He underwent an underlay ventralex mesh repair.He has been doing well.Over the last few months, he noticed some fullness to the right lower abdominal wall area just to the right at the midline.There was been no fever, chills, nausea, vomiting.Overall, he feels well.He is not sure if he does have a recurrence hernia.He is an obese gentleman with diabetes and high blood pressure.¿ ¿he has only mild discomfort to the area.There is no palpable subcutaneous bulges or masses.¿ ¿abdomen: soft, distended.He has a long scar in the midline.No cellulitis.No open wound.The right lower paramedian area seems fuller compared to the left side but due to his body habitus it is hard to determine if this is a hernia.It is mildly tender.No open wound.No masses.¿ ¿the plan is to get a ct scan of his abdomen and pelvis for further evaluation.Should he have a recurrent hernia, i would recommend repairing.I also encouraged him to lose some weight that might help with his high blood pressure and diabetes.¿ (b)(6) 2015: ct abdomen/pelvis: ¿the patient is status post previous ventral hernia repair in the upper abdomen.Widemouth ventral hernia in the upper abdomen contains fat and nonobstructed small and large bowel.The hernia defect measures 8.7 cm in transverse and 8.8 cm in craniocaudal dimensions.There is also been prior umbilical hernia repair without evidence of a recurrent umbilical hernia.No hernia is identified in the lower anterior abdominal wall.¿ (b)(6) 2015: open repair of chronically incarcerated incisional hernia with an inlay composite polyester mesh ¿a #15 blade was used to excise this scar.Electrocautery then was used to carry the incision down slowly to the abdominal wall fascia.We immediately encountered the hernia sac.Sac was entered.There was moderate amount of omentum and small bowel inside the sac itself.This was slowly lysed from the sac.The sac then was fully dissected out of the subcutaneous tissue and excised along the fascial edges.He did have very attenuated fascia, but there was fortunately minimal adhesion to the anterior abdominal wall.After this was sac was excised, the fascial defect is measured to be approximately 8 x 8 cm.A composite polyester mesh was used for the repair.It was inset in an inlay fashion with running #1 prolene.There was just adequate tension on the mesh to allow it to be nicely laid down flat without too much tension to the abdominal wall.A #15-french solid round silicone drain was placed on top of the mesh and brought out through the right side of the incision.The midline incision was closed with running 2-0 vicryl deep tissue layer, interrupted 3-0 vicryl for the dermal layer, and the skin was reapproximated using staples.¿ (b)(6) 2015: ct abdomen/pelvis: ¿post surgical changes, status post recent ventral abdominal wall hernia repair.Hematoma within the overlying subcutaneous soft tissues measures 17.0 x 5.4 x 5.8 cm and contains a surgical drain.Mild diastases of the ventral abdominal wall just superior to the hernia repair where a loop of small and large bowel partially extends into the area of diastases without definite resulting obstruction.Multiple abnormally dilated loops of small bowel throughout the abdomen are noted without definite high-grade transition point identified.Findings may be on the basis of postoperative ileus.¿ (b)(6) 2015: evacuation and washout of a subcutaneous hematoma following incisional hernia repair ¿this is a 63-year-old gentleman with recurrent incarcerated incisional hernia repair who underwent an inlay repair about five days ago.Postoperatively, he developed a pulmonary embolus.He has been on anticoagulation.He developed a large hematoma in the subcutaneous tissue above the mesh as the hematoma itself is impressive in size.He has some additional discomfort from this, which leads to some compromise in his respirations due to the size of the hematoma, he was symptomatic from it, and the fact that there was concern that this could develop into an infection right above the mass, i decided to come back for washout.¿ ¿the staple along the midline was removed.We immediately encountered a large pocket of mixed clotted and liquefied hematoma.This was all evacuated.The mesh repair is intact.No evidence of any dehiscence or hernia recurrence.¿ (b)(6) 2015: ¿patient status: remains critically ill.¿ ¿interval history: -patient is a 63 year-old aa male with history of [non-insulin dependent diabetes mellitus] and [hypertension] who is [postoperative day] #5 inguinal hernia repair that was complicated by a peri-operative [pulmonary embolism], [acute kidney injury], ileus, and hematoma.¿ [postoperative day] #1 evacuation and washout of abdominal hematoma following incisional hernia repair.¿ abdominal exam notes state: ¿abdomen round, slightly distended, and non-tender.Positive bowel sounds.Liquid stool.Surgical site clean and intact.Jp drain x1 with serosanguineous output.¿ conclusions: it should be noted that the gore® dualmesh® plus 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.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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 records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 7309658 additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].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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