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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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Back to Search Results |
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| Model Number 1DLMCP07 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 06/16/2015 |
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Event Type
Injury
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Manufacturer Narrative
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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)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus 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.
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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) 2012 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: open draining wound, surgery to remove mesh, infection, scarring, adhesions, severe and chronic pain/discomfort.Additional event specific information was not provided.
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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: relevant medical information: on (b)(6) 2010: (b)(6) hcs.(b)(6), msn, fnp-bc; (b)(6).History and physical.Chief complaint: left inguinal hernia.Possible right inguinal hernia, umbilical hernia.History of present illness: 43 year old with history of reducible umbilical hernia in (b)(6) 2009, but by (b)(6) 2010 has had progressively worsening umbilical hernia that patient was unable to reduce on his own, with increased pain 8 (0-10), additionally with bilateral groin pain, diagnosed with left inguinal hernia, and possible right inguinal hernia 8 (0-10) here for surgery.Weight 225 pounds.Exam: non-distended, normoactive bowel tones, no ventral or umbilical hernias.Right and left upper quadrant bowel sounds, unable to examine rest of abdomen and suprapubic area due to elastic abdominal binder patient has on.Tender in lower ½ of abdomen.Umbilical hernia-not visualized, groins-no visualized due to binder.Impression/plan: schedule for laparoscopic left inguinal hernia, possible right inguinal hernia and open umbilical hernia repair (b)(6) 2010.On (b)(6) 2010: (b)(6) hcs.(b)(6), md; (b)(6).Operative report.Preoperative diagnosis: left inguinal hernia, possible right inguinal hernia, umbilical hernia.Postoperative diagnosis: left inguinal hernia, umbilical hernia.Procedure: 1.Laparoscopic left inguinal hernia repair with mesh.2.Umbilical hernia repair with an onlay mesh.Anesthesia: general endotracheal anesthesia.Attending surgeon: (b)(6), md.Primary surgeon: (b)(6), md.Estimated blood loss: less than 11 ml.Findings: small left inguinal hernia and a large umbilical hernia defect.Brief history: the patient is a 43-year-old male with a history of having multiple hernia, which was been incarcerated multiple times requiring ed visits.Each time, the patient has been able to reduce it.However, the patient was recently seen in clinic due to the nature of frequent incarcerations and frequent hospital visits.It was thought that he should have his surgery sooner rather than later.The patient was then scheduled for laparoscopic hernia repair with umbilical hernia repair to evaluate if he actually, indeed, had a right inguinal hernia.Operative procedure: ¿the patient was placed on the table in a supine position.The patient was prepped and draped using sterile technique.A time out was then taken.At this time, a 5-mm incision was made above the patient¿s umbilicus, superior to his hernia.The tissues were dissected down using a kelly clamp until the anterior abdominal fascia was seen.A veress needle was then inserted into the abdomen under careful direction.The abdomen was then insufflated to 13mmhg.A 5-mm trocar was then advanced through the hole into the patient¿s abdomen under direct visualization using a visiport.Once the port was placed in the abdomen, it was examined, and the patient was clearly noted to not have a right inguinal hernia.The patient did have a definite left inguinal indirect hernia.The patient did have an umbilical hernia with no bowel incarcerated in either of the patient¿s right side.We placed to more 5-mm ports in the patient¿s right upper quadrant and right lower quadrant.We then began the dissection by taking down the peritoneum overlying the patient¿s left inguinal region very carefully using a combination bovie dissection and blunt dissection.We were able to strip peritoneum down making a minimal number of holes until we located all of our important points, including the pubic tubercle, copper ligament, the femoral vessels, epigastric vessels and where the peritoneum was actually stuck into the internal inguinal ring.At this point, we began dissecting the peritoneum out of the inguinal ring and were able to do so; however, we made a few rents in the patient¿s peritoneum.No bleeding was encountered during the procedure.We were very careful not to take the patient¿s vas or any of the patient¿s nerves, and we stayed out of dangerous regions and were very careful not to injure the patient¿s major blood vessels.At this point, we were very happy with our dissection and proceeded by up sizing our supraumbilical port to a 12-mm port so we could place the mesh through the port.We were able to place the mesh into the patient¿s abdomen.It was a perietex mesh, which we were able to place intact to the patient¿s cooper ligament.We then placed multiple tacks into the cooper ligament and then placed a few tacks in the left anterior quadrant, making sure not to go anywhere near the patient¿s epigastric vessels.We placed a few more securing tacks in the left lower quadrant.At this time, we were happy with our mesh placement, and we decided to cover it up using the peritoneum.We lifted the peritoneum back up over the mesh and tacked that down using tacks.At one point, the rent in the patient¿s peritoneum was closed by taking the patient¿s leftover fat pad that was dangling of his urachus and draping it across and tacking it down.At this time, we were very happy with our closure.We noticed no bleeding, and we turned our attention now to the umbilical hernia.We pulled our instruments out and then pulled out our trocars and desufflated the patient¿s abdomen.We then made a semi-circular incision above the patient¿s umbilicus.We were able to dissect out the umbilicus.We used a combination of blunt dissection and bovie cautery to encircle the entire umbilicus.Once we had done so, we then tuned our attention to transecting the umbilicus sac off of the hernia sac.We were able to do so without injuring the patient¿s umbilicus or injuring the patient¿s intraabdominal organs.Once done, we notices that the patient had a large fascia deficit, and we connected our trocar site with the patient¿s fascial deficit as there was less than 5 mm of fascia between the two.Once done, we decided to close it by using interrupted vertical mattress sutures with 3-0 tr-cron sutures in an interrupted fashion.We placed about 6 sutures and tied them down.We were happy with our closure and found it to be air tight and abdominal tight.We dissected out a 2-cm area around the patient¿s fascial defect.Once done, we then took the parietex progrip mesh, placed it as on onlay patch onto the wound.Once done, we created the patient¿s umbilicus by taking a 3-0 vicryl and suturing the umbilicus down into proper position.We then closed the wound by using 3-0 vicryl in an interrupted fashion to the deep dermis.We then closed skin using a 4-0 monocryl in a subcuticular fashion.We closed the suture sites using 4-0 monocryl in a subcuticular fashion.We then placed dermabond over all of the wounds and placed 4 x 4s and tegaderms over the wound sites.Instrument counts, needle counts and sponge counts were all correct at the end of the case.Dr.(b)(6) was scrubbed for the entire procedure.The patient was extubated and transferred to the dou due the patient¿s having sleep apnea.¿ on (b)(6) 2010: (b)(6) hcs.(b)(6), rn.Nurse notes.Wound classification: clean.Prosthesis installed: parietex mesh.On (b)(6) 2010: (b)(6) hcs.(b)(6), md; (b)(6).Discharge summary.Date of admission: (b)(6) 2010.Date of discharge: (b)(6) 2010.Chief complaint: hernia.Principal diagnosis: left inguinal hernia, umbilical hernia.Secondary diagnosis/complications/comorbidities: impaired fasting glucose, elevated liver enzymes, hypertension, depression.History testicular torsion at age 15.Hospital course: admitted on (b)(6) for a schedule laparoscopic hernia repair and open umbilical hernia repair.Patient was brought to the pre-operative area, he was consented and all risks and benefits of the procedure were discussed with patient in detail.Taken to operating room, tolerated the operation with no complications.Admitted to dou surgery services secondary to his sleep apnea.On postoperative day 1, patient¿s diet was advanced to a regular diet with no complications.Pain controlled well with vicodin.Patient was ambulating, able to urinate and meeting all activities of daily living.Follow up in general surgery clinic in two weeks.Light activities are tolerated no heavy lifting.No baths, showers ok.On (b)(6) 2010: (b)(6) hcs- lj emergency department.(b)(6).Radiology- abdominal series.Indication: evaluate for perforation.Impression: no evidence of perforation or obstruction.On (b)(6) 2011: (b)(6) hcs.(b)(6), rn, msn, canp; (b)(6), md.History and physical.Chief complaint: umbilical hernia.History of present illness: 43 year old male with history of open umbilical hernia repair (b)(6) now with recurrence, started popping out right after surgery, pain, increase in size, wears a truss, here for surgery.Weight 220 pounds.Exam: abdomen non-distended, non-tender, normoactive bowel tones, no masses, spleen not palpable.Umbilical hernia with tender to palpation, has truss on.Impression/plan: umbilical hernia scheduled for (b)(6).On (b)(6) 2011: (b)(6) hcs.(b)(6); (b)(6), md.Operative report.Attending surgeon: (b)(6), md.Assistant surgeon: (b)(6), md.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: incisional hernia.Procedure(s): 1.Exploratory laparotomy.2.Removal of mesh.3.Small bowel resection and primary anastomosis.4.Closure of hernia defect.Indication for procedure(s): this is a 43-year-old who underwent a previous umbilical hernia repair.He was noted to have a recurrence of the umbilical hernia and presented for definitive management.Operation in detail: ¿after obtaining the proper informed consent, the patient was brought to the operating room and placed on the operating room table in the supine position.General endotracheal anesthesia was initiated.The abdomen was prepped and draped in the usual sterile fashion.Dvt prophylaxis was initiated, and preoperative antibiotics were given.We began the operation by opening the previous supraumbilical curvilinear incision.We dissected down and identified the previously placed mesh.We continued circumferentially in all directions around the mesh, removing subcutaneous tissue from the densely adherent mesh.We were able to gain entry into the abdomen near the superior aspect of the large hernia defect.Once intraperitoneal exposure was obtained, circumferential dissection of the hernia defect and fascia began.We were able to free the first and superior most portion of the defect.However, laterally, there was densely adherent bowel within the hernia sac and adherent to the previously placed mesh.We meticulously and carefully got through these adhesions.However, a number of small bowel serosal injuries occurred.These injuries were initially repaired lembert 3-0 silk sutures.Once we were able to fully mobilize the intestines and small bowel from the hernia sac, we noted that the mesh which was placed previously had become densely adherent to the small bowel and caused a kinking of the small bowel in this area.We were concerned that the mesh would continue to erode into the bowel.Given the pre-obstructive type symptoms that this patient was experiencing as well as the tight twisting within the loops of the bowel at the level of the mesh, we determined that resecting this segment would be the most prudent measure.With this in mind, we extended our resection margins approximately 15 cm more proximally to incorporate the areas of serosal injury, so that at completion of this small bowel resection there were no areas of small bowel which were deseasonalized and repaired.In total, approximately 30 cm of small bowel was resected.We did this by making mesenteric defects and dividing the bowel with a linear gia blue loaded stapler and dividing the mesentery between clamps.A side-to-side functional end-to-end anastomosis was performed by creating 2 enterotomies with mayo scissors and firing the gia stapler on the antimesenteric border of the small bowel.The enterotomies were closed after grasping the mucosal edges with ta stapler, and a single ta stapler fire closed the enterotomies.The remaining small bowel was trimmed with the mayo scissors and passed off the field as a specimen.There was excellent blood supply to the bowel.There was some small bleeding of the suture line that was controlled by application of pressure for 2 minutes.Following this, the mesenteric defect which was created was closed using interrupted silk sutures.The small bowel was returned to the abdomen.The hernia was this ensued.Overall, the fascial defect was an approximately 8 cm x 8 cm circular defect.The anterior fascial layers were mobilized by using the bovie cautery to dissect the subcutaneous tissue and created an undermined surface of approximately 4 cm circumferentially.Using interrupted #1 pds sutures in a vertical mattress suture, the fascia was then closed.Following completion of this, the remaining hernia sac was excised from the subcutaneous tissues, and a drain was placed into the bed space.So, the #10 jackson-pratt drain was brought out independent fashion and sutured in place.The umbilicus was recreated using interrupted vicryl sutures.Then the subcutaneous tissues were approximated with 3-0 deep dermal sutures, and the skin was closed with running 4-0 monocryl subcuticular stitches.The wounds were cleaned and dried.Steri-strips were applied as well as sterile occlusion dressing.The patient was awoken and taken to the post-anesthesia care unit in stable condition.The attending physician, dr.(b)(6), was present and participated throughout the entire operation.¿ on (b)(6) 2011: (b)(6) hcs.(b)(6), rn.Nurse notes.Wound classification: clean.On (b)(6) 2011: (b)(6) healthcare system.(b)(6).Surgical pathology.Accession no.Sp (b)(4).Specimen (received february 23, 2011): a.Umbilical hernia sac.B.Small bowel.Brief clinical history: recurrent umbilical hernia.Preoperative diagnosis: recurrent umbilical hernia.Postoperative diagnosis: recurrent umbilical hernia.Gross description: the specimen is received in two formalin filled containers, each labeled with the patient¿s name and id number.Part a is received in formalin, labeled ¿umbilical hernia sac permanent.¿ it consists of two fragments of unoriented brown/tan fibroadipose tissue, the larger of which measures 9.0 x 1.8 x 0.2 cm and the smaller of which measures 1.8 x 0.7 x 0.3 cm.Serial sectioning through the specimen reveals a white/tan/yellow fibroadipose tissue with no additional findings.Two representative sections are submitted in cassette a1.Part b is received fresh, labeled ¿small bowel permanent.¿ the specimen is placed in formalin and allowed to fix overnight, and following overnight fixation is examined to reveal a single unoriented portion of small intestine measuring 32.0 cm in length and 2.5 x 3.0 cm in diameter.The serosal surface of the small intestine appears roughened and thickened throughout the specimen.Additionally, there is an 11.0 cm portion of small intestine that is densely adherent creating a loop with adherent overlying scar tissue.Two staple lines are present at either end of the specimen.The specimen is opened to reveal intact small intestinal mucosa with normal plicae circulares.The bowel lumen is unobstructed, and the mucosa is pink/tan and velvety is appearance.A focal area of submucosal hemorrhage is identified, which measures 3.0 x 1.4 cm and which extends to within 1.0 cm of one of the unoriented resection margins (the resection margin closest to the adhesed loop of small intestine).Closer examination of this area reveals a defect in the serosal surface, which measures 0.5 cm in length and which is closed with silk sutures.No other mucosal abnormalities are identified.Microscopic diagnosis: a.Hernia sac, umbilical, resection: consistent with hernia sac.B.Small intestine, resection: fibrous adhesions, focal mucosal necrosis, margins viable; one lymph node, no evidence of malignancy.On (b)(6) 2011: (b)(6) hcs.(b)(6), md; (b)(6).Operative report.Supervising attending surgeon: dr.(b)(6).Preoperative diagnosis: umbilical hernia.Postoperative diagnosis: umbilical hernia.Procedure: surgical repair of umbilical hernia with mesh and component separation.Anesthesia: general endotracheal anesthesia.History of present illness: mr.(b)(6) is a 43-year-old male who has a long-standing history of umbilical hernia.Of note, he has undergone two previous repairs, one only three days ago.At this time he is returning to the or for a third umbilical hernia repair.Operative course: ¿after informed consent was obtained, the patient was brought to the operating room, placed in the supine position, prepped and draped in the normal sterile fashion, given dvt prophylaxis in the form of scds, and was administered a preoperative dose of ancef.We began the repair of the umbilical hernia by opening his previously-made 8 cm curvilinear incision along the superior margin of the umbilicus with a #10 blade scalpel and electrocautery.The umbilical stalk was severed and preserved for later attachment and care was taken to identify the adjacent hernia contents and the corresponding fascial defect.In this case the hernia did not contain any loops of bowel but it did contain omental fat.At this time we took a moment to view our previous closure only three days old and we saw that the sutures were in place, broken, with knots still tied.For this reason we proceeded to perform a component separation to free up the tension in his abdominal wall by undermining and then releasing the external oblique muscle bilaterally just lateral to the rectus muscles.We then repaired the fascial defect first by dunking the peritoneal contents inside the facial defect.We first placed a mesh 8 cm in diameter on the inside surface of the fascia and sutured it into place with #3-0 prolene sutures on each side.To provide extra strength, we then used eight vertical mattresses to close this posterior rectus fascial sheath with #0 prolene sutures.We then closed the anterior rectus fascia with a running #0 prolene stitch.To close the component separation we sutured the subcutaneous fascia to the external oblique fascia with #2-0 prolene sutures on each side lateral to the rectus muscle.Afterward we used #2-0 vicryl to re-attach the umbilicus to the underlying fascia, recreating the natural umbilical indentation.We then inserted a #12 french jp drain into the original site lateral and inferior to the umbilicus and surgical site.We then used continuous #2-0 vicryl to close the deep dermal layer and close the skin with a running #4-0 monocryl subcuticular stitch.With the skin being closed at the operative site, benzoin and steri-strips were applied and tegaderm placed as a dressing.Before this closure we injected 30 ml of ¼% marcaine with epinephrine.¿ level of attending supervision: the attending was present and participated throughout the entire procedure.Specimens: none.Fluid in: 1000 ml.Ebl: 25 ml.Urine output: not measured.Complications: none.On (b)(6) 2011: (b)(6) hcs.Implant record.Implant: gs (composit mesh).Vendor: prietex composite by (b)(4).On (b)(6) 2011: (b)(6) hcs.(b)(6), rn, bsn.Nurse notes.Wound classification: clean.On (b)(6) 2011: (b)(6) hcs.(b)(6), md; (b)(6).Discharge summary.Date of admission: (b)(6) 2011.Chief complaint: recurrent umbilical hernia.Principal diagnosis: recurrent umbilical hernia.Hospital course: admitted after a previous umbilical hernia repair failure.The day of admission he was given mesh repair which was complicate by adherent bowel requiring a small bowel resection.By postoperative day 3 he was tolerating a regular diet and had bowel function.However, on postoperative day 3 he was noted to have an umbilical hernia recurrence and was taken urgently back to the operating room for immediate repair.This repair was also with mesh, but reinforced in multiple layers.Postoperatively, he recovered quickly, advancing his diet to clears on postoperative day 1 and to a regular diet postoperative day 2.On postoperative day 2 he was prepared for discharge, ambulating the floor, tolerating a regular diet, passing bowel movements, and with a stable hernia repair in an abdominal binder.He will follow up on wednesday in clinic for removal of jackson-pratt drain.Minimize exertion for six weeks, okay to shower, no bathe.On (b)(6) 2011: (b)(6) hcs.(b)(6).Operative note.Addendum: ¿the vertical mattress sutures were full thickness rectus sheath, spaced closely.The component separation incision was not closed; rather, the abdominal wall was anchored to the mobilized fascia to close dead space with 2-0 vicryl sutures.The drain was a #10 jp.The patient did well and was discharged on (b)(6).¿ on (b)(6) 2011: (b)(6) hcs- (b)(6) general surgery office.(b)(6).Radiology- ct abdomen pelvis with and without contrast.Indication: evaluate for possible recurrent umbilical hernia.Findings: diastases of the rectus abdominis muscle with umbilical wide neck fat-containing hernia likely containing omental fat.The neck measuring approximately 2.3 cm.Associated fat stranding surrounds the umbilical hernia.Evidence of prior left inguinal hernia repair with mesh material and coils.On (b)(6) 2012: (b)(6) hcs.(b)(6), rn, msn, fnp; (b)(6).History and physical.Chief complaints: recurrent umbilical hernia.44 year old male with symptomatic recurrent umbilical hernia preoperative for laparoscopic repair of recurrent umbilical hernia with mesh.He is status post open umbilical hernia repair (b)(6) 2011.He states it reoccurred in 3-4 months.No tobacco use.Occupation history/toxin exposure: asbestos/agent orange exposure.Weight 220 pounds, height 6¿0¿ inches.Exam: abdomen soft, normoactive bowel tones, tender to palpate around umbilical area, well-healed supraumbilical scar.No obvious hernia present to exam, mild rectus diastases.Area of discreet ¿hardness¿ about 3 cm below umbilicus, could be a stitch.Implant procedure: laparoscopic ventral hernia repair with gore dual mesh plus.Implant: gore® dualmesh® plus biomaterial [1dlmcp07/(b)(6), 20cm x 30cm x 1 mm].Implant date: (b)(6) 2012 (hospitalization (b)(6) 2012).On (b)(6) 2012: (b)(6) hcs.(b)(6).Operative report.Case number: (b)(4).Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: recurrent ventral hernia.Assistant surgeon: (b)(6), md.Medical student: (b)(6), ms3.Anesthesia: general endotracheal anesthesia.Description of procedure: ¿this is a 44-year-old male with past surgical history of 3 prior open attempts of umbilical hernia repair, last in (b)(6) of 2011.Following informed consent, as well as pre-op huddle per va protocol, the patient was brought to the operating room where general anesthesia was induced without complication.The patient was positioned with bilateral arms padded and tucked.A foley catheter and og tube were placed.The abdominal hair was trimmed with clippers, and a sterile drape, and prep was performed.A final time-out was performed per hospital protocol, as well as pre-op antibiotics of 1 gram of ancef given per hospital protocol.Following local anesthesia, the abdomen was entered via a 5 mm incision at palmer¿s point using the visiport.We entered the abdomen with ease and insufflated.The mesentery was immediately visible, adherent to the abdominal wall into two separate regions of a ventral hernia.The first region was 3 cm in diameter and the umbilicus; a second ventral hernia was visualized inferior to this, and was approximately 2 cm in diameter.After placing a 12 mm port inferior and lateral to the initial port, we inserted the 30-degree laparoscope, and began initially taking down the omental adhesions to the abdominal wall bluntly with laparoscopic debakey grasper.Next, we noticed that the omentum was inflamed, and friable, and oozy; and therefore, took down the remainder of the omental adhesions utilizing a bipolar cautery device by covidien.After the adhesions were taken down and hemostasis achieved, the gore dual mesh plus was measured so that greater than 5 cm extended on each side of the fascial edge of the hernia.Of note, no bowel was involved in the hernia, it was only omentum.Following hemostasis which was achieved with cautery of the anterior abdominal surface, we trimmed the dual mesh gore-tex mesh to the right size, and placed a single gore-tex suture on each side of the mesh.The mesh was then rolled, and advanced into the abdomen through the 12 mm port, and unfolded intra-abdominally.Next, four small incisions were made superior, inferior, and laterally to the ventral hernias; and the laparoscopic suture passers were advanced through each of these holes to grab the gore-tex suture intra-abdominally, and pull them up through the fascia.This was done on each of the four sides of the gore-tex graft.The gore-tex mesh was then elevated to be flush with the anterior abdominal wall, and the gore-tex sutures were tied down.Next, a laparoscopic tacker was used to place interrupted 1 cm tacks along the entire circumference of the gore-tex mesh.Lastly, an endo stitch was used to place a 2-0 vicryl stitch, and close the 12 mm port site.Excellent hemostasis was noted postoperatively, and the port sites were inspected as we removed the ports.Of note, 2 separate additional 5 mm ports had to be placed on the right side of the abdomen in order to visualized and finalize the tacking process of the mesh.The skin was closed with 4-0 monocryl running subcuticular stitches, dermabond, and a sterile dressing was applied.The patient tolerated the procedure well.¿ level of supervision: dr.(b)(6) was present and scrubbed throughout the entire procedure.Disposition: the patient was transferred to the dou with stable vitals.On (b)(6) 2012: (b)(6) hcs.Implant record.Implant: gs (dualplus mesh).Vendor: gore (spd delivery).Model/catalog: ref#1dlmcp07.Lot/serial no: (b)(6).Size: 20cm x 30cm x 1mm.Quantity: 1.The records confirm a gore® dualmesh® plus biomaterial 1dlmcp07/(b)(6) was implanted during the procedure.See attachment for h10/11 continuation.
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus 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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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.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® 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.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.C1: 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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