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| Catalog Number 1DLM204 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930)
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| Event Date 01/07/2002 |
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Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device were not provided.Therefore, a review of the manufacturing records could not be performed.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent open diaphragm repair on (b)(6) 2001 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2002, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: surgery to remove mesh, infection, open draining wound, scarring, abscess.Additional event specific information was not provided.
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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: implant procedure: wide excision of chondrosarcoma right chest well.Resection of portion of ribs seven, eight, and nine with skin, soft tissue, portion of diaphragm.Gore-tex patch reconstruction of 20 x 20 cm defect right chest wall (00520937, 1dlm204, patch dual mesh 2m 26x34c, w.L.Gore).Coverage of gore-tex graft with latissimus dorsi muscle flap.Implant: gore® dualmesh® biomaterial [00520937/1dlm204, 26x34 cm].Implant date: (b)(6) 2001 (hospitalization [ni]) on (b)(6) 2001: (b)(6) clinic.(b)(6).Operative report.[preoperative diagnosis]: right chest wall chondrosarcoma, status post resection (elsewhere).Assistant: (b)(6).Drainage: 1 chest tube, 2 blake drains.Asa ii.[procedure]: ¿the patient was brought to the operating room in satisfactory condition.Under general endotracheal anesthesia with a double-lumen endotracheal tube, the patient was placed in the lateral decubitus position with the hip tilted somewhat back and prepared from the symphysis pubis to the contralateral side of the rectus to the spine.The patient¿s previous chondrosarcoma incision and chest tube sites were identified, and an elliptical incision was made about the previous incision, incorporating the incision and all tube and drain sites.Subcutaneous tissue below the incision was excised.Incision was carried directly down to the chest wall, and all surrounding muscle and ribs for greater than 4 cm in all directions about the previous resect were removed.This resulted in a 20- x 20-cm defect.A portion of the diaphragm was removed with the resected specimen.Hemostasis was found to be secure.The wound including the upper abdomen was copiously irrigated with saline.There were no palpable pulmonary masses.There was no nodularity of the parietal pleura.The defect within the diaphragm was closed primarily using interrupted 0 prolene suture placed in a figure-of-eight fashion.The chest wall defect was closed utilizing 2-mm thick gore-tex patch secured in place with interrupted 0 prolene suture.Pleural cavity was copiously irrigated with saline followed by ancef solution.Dr.(b)(6) from the division of plastic surgery then came to the operating room and proceeded with his portion of the procedure¿dr.(b)(6).The patient was previously consented and brought to the operating room by dr.(b)(6).He underwent his wide resection of chondrosarcoma which included a large portion of the right anterolateral chest well.This was closed with gore-tex mesh.At this point plastic surgery was called for muscle flap closure.First, we undermined the wound skin and subcutaneous tissue circumferentially.Next, the right latissimus dorsi muscle was mobilized in its entirety.This was done in standard fashion by identifying it anteriorly, mobilizing all the skin and subcutaneous tissue directly off the anterior surface of the latissimus.This was completely mobilized to its origin along the thoracic spine and lumbar paraspinal fascia.Dissection was then carried anteriorly until the muscle was completely exposed.Next, the lateral border was identified and mobilized.The serratus anterior was also identified and separated form the latissimus dorsi.Next, mobilization of the muscle was begun at its most inferior origin.Its attachments to the lumbosacral fascia were divided.This was carried superiorly completely mobilizing the flap cephalad.Care was taken to identify the thoracodorsal pedicle.The entire origin was dissected and freed.Dissection was then carried along up into the axilla, again careful to protect the pedicle.The insertion was not divided.The muscle was also elevated and freed form the tip of the scapula.This gave us excellent arc of rotation which completely covered the chest wall defect without any tension.Next, the muscle flap was inset using interrupted horizontal mattress 3-0 monocryl suture.This gave us an excellent, water-tight closure.Next, two large flat blake drains were placed, one anteriorly and one posteriorly.The skin was reapproximated, initially with large 0 vicryl suture subcutaneously.This gave us good overall reapproximation.Then the dermal and subcutaneous layers were closed with interrupted 2-0 vicryl sutures.Skin was reapproximated with a running subcuticular 3-0 monocryl suture.Of note, a chest tube was placed by thoracic surgery prior to closure of skin.Dr.(b)(6).Prior to dr.(b)(6) closing the subcutaneous layers and skin, a 32-french straight chest tube was placed into the pleural cavity under direct vision without difficulty.The patient tolerated the operative procedures well, left the operating room in satisfactory condition¿dr.(b)(6).¿ on (b)(6) 2001: (b)(6) clinic.Implant record.Gore-tex patch.00520937, 1dlm204, patch dual mesh 2m, 26x34c, w.L.Gore.The records confirm a gore® dualmesh® biomaterial (00520937/ 1dlm204) was implanted during the procedure.Relevant medical information: on (b)(6) 2001: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct chest, abdomen and pelvis.Indications: fevers, s/p chest wall resection.[findings]: postoperative changes involving right chest wall with a mesh within the right lateral chest wall.A small amount of fluid lies adjacent to the mesh, most consistent with postoperative changes.Scattered atelectasis or fibrosis in the right lung with a small amount of fluid or resolving hematoma in the right upper lung posteriorly measuring 4.5 cm.Several small inguinal lymph nodes and retroperitoneal lymph nodes are within normal limits for size.Small right pleural effusion.Moderate esophageal hiatal hernia.Benign lipoma involving the musculature of the lower right oblique muscles.Explant procedure: redo limited right thoracotomy.Removal foreign body (gore-tex mesh).Debridement and irrigation wound.Wound packing.Explant date: (b)(6) 2002 (hospitalization [ni]) on (b)(6) 2002: (b)(6) clinic.(b)(6).Operative report.[preoperative diagnosis]: status post extensive right chest wall resection.History of chondrosarcoma.Infected gore-tex mesh.Assistant: (b)(6).Asa ii.[procedure]: ¿the patient was brought to the operating room in satisfactory condition.Under general endotracheal anesthesia with a single-lumen endotracheal tube, patient was placed in the left lateral decubitus position with the hips rolled back.The draining sinus tract on the patient¿s skin had preoperatively been identified.The patient¿s thoracotomy incision about either side of the draining sinus tract was reopened.Using a combination of sharp and electrocautery dissection, dissection was carried down through extensive scar tissue.Minimal muscle was encountered.The sinus tract was probed, the cavity entered, and the wound further opened about the probe.The sinus tract did track down to the patient¿s gore-tex mesh and purulent material about the mesh was encountered.Appropriate specimens were submitted for culture.The gore-tex mesh and surrounding prolene sutures were removed in their entirety.Hemostasis was found to be secure.We did not appear to enter the abdominal cavity.Hemidiaphragm was beneath the gore-tex mesh.We did not appear to enter directly the pleural cavity.Hemostasis was found to be secure.The wound debrided.There was good healthy viable tissue.The muscle flap i suspect was fixed to the subcutaneous tissue and was above the area of the abscess cavity.The abscess cavity was then pulse irrigated with 3 l of saline solution, again, debrided, and then packed with dabs soaked kerlix gauze.The patient tolerated the operative procedure well and left the operating room in satisfactory condition.¿ relevant medical information: on (b)(6) 2002: (b)(6) clinic.(b)(6).Operative report.[preoperative diagnosis]: infected right chest well cavity, status post-removal gore-tex mesh.Irrigation, debridement, and wound packing.Assistant: (b)(6).Asa ii.[procedure]: ¿the patient was brought to the operating room in satisfactory condition.Under general endotracheal anesthesia, the patient was prepared and draped in the usual fashion.The previously placed kerlix gauze was removed.The wound appeared quite clean.Using curets, sharp dissection of the wound was performed.The wound was then pulse irrigated with saline and the wound then repacked with dabs-soaked kerlix gauze.The patient tolerated the operative procedure well and left the operating room in satisfactory condition.¿ on (b)(6) 2002: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct chest, abdomen.Indications: sarcoma follow up.[findings]: partial right lower chest wall resection.The infected gortex graft has been removed.The amount of postoperative edema and fluids has decreased considerably in the operative bed.Esophageal hiatal hernia.Calcified granuloma left lower lobe medially.Slight fibrosis right mid and lower lung.Calcified left hilar lymph nodes.Remainder negative.On (b)(6) 2002: (b)(6) clinic.(b)(6).Operative report.[preoperative diagnosis]: nonhealing right chest wall wound.Wide excision of right chest wall wound.Dissection portion of rib.Debridement.Layered closure.Assistant: (b)(6).Asa ii.[procedure]: ¿the patient was brought to the operating room in satisfactory condition.Under general anesthesia endotracheal anesthesia with a single lumen endotracheal tube, the patient was placed in the lateral decubitus position, prepared, and draped in the usual fashion.The patient¿s draining wound was again identified and careful probing of the wound failed to reveal any obvious fistula tracts.A wide elliptical incision about the wound was made and the dissection was carried down through normal tissue to the level of the patient¿s chest wall.At the lowermost aspect of the resected tissue interiorly there appeared to be a small sinus tract.This tracked down beneath the rib and came into proximity with some small remnants of prolene suture.There was no pus encountered.No other obvious abnormalities were identified.After resection of the tissue and a portion of that rib, healthy tissue without and evidence of fistula tracts or foreign body was observed.The wound was irrigated with several liters of saline followed by ancef solution.We then closed the wound in multiple layers with vicryl suture for the deep layers and interrupted 3-0 nylon suture on the skin.A large flat jackson-pratt drain had been left.The patient tolerated the operative procedure well, left the operating room in satisfactory condition.¿ on (b)(6) 2002: (b)(6) clinic.(b)(6).Procedure report.Indication: melena, anemia, orthostasis.Esophagogastroduodenoscopy with epinephrine injection and heater probe thermoregulation.[procedure]: following the pre procedure patient assessment, the procedure, goals, risks, and alternatives were reviewed.I attended the entire viewing portion of the procedure.After titrated sedation, the olympus therapeutic gastroscope was advanced under direct vision into the proximal esophagus.This was modestly challenging due to atypical hypopharynx and very prominent arytenoid folds with lateral attachments to the sides of the pharynx, which yielded a dominant pathway into the airway.The esophagus was normal down to the esophagogastric junction at 37 cm from the incisors.At the that level there was a superficial ulcer consistent with peptic change.Distal to this was a large hiatal hernia encompassing the majority of the fundus in a twisted intrathoracic position.At the diaphragmatic hiatus there were at least two ulcers.One appeared quite bland and linear and the other was best seen from below but exhibited a white base with elevated pigmented spots consistent with a small adherent clot.There was scattered old solid clot free floating within the stomach.Following aspiration of clear fluid and some old clot, the remainder of the stomach was noted to be normal.The pylorus, duodenal bulb, angle, and the postbulbar duodenum were also normal.On returning to the ulcer with adherent clot on the gastric side of the diaphragmatic hiatus, we injected a total of 9 cc of epinephrine in approximately five sites.Thereafter the large bore heater probe was applied a total of ten to twelve times with initially stimulated bleeding and subsequent good hemostasis and a dry field.This was all done from a retroflexed position.The procedure was tolerated fair.It was performed without apparent complication.The patient was assessed upon completion of the procedure.[impression]: large diaphragmatic hernia; cameron ulceration with associated visible vessel and adherent clot; esophagogastric junction ulcer; scattered coffee grounds material; normal duodenum.On (b)(6) 2002: (b)(6) clinic.(b)(6) , md; (b)(6) , md.Discharge summary.Discharge diagnosis: upper gastrointestinal bleed due to cameron ulceration.Diaphragmatic hernia.Anemia secondary to gastrointestinal bleed.Patient transferred from medical intensive care unit after treatment of upper gastrointestinal bleed.Patient eight days ago developed nausea, chills, and leg cramps.Passed liquid tarry stools.In the days followed, experienced several more black tarry stools with associated tachycardia, palpitations, shortness of breath, progressive weakness, and a low-grade fever.Evaluated in outside hospital, found to have hemoglobin of 6.1.Transfused 11 units of packed red blood cells before admission to intensive care unit.Performed an emergent endoscopy.They found a large diaphragmatic hernia with cameron ulceration and associated visible vessel with adherent clot.The cameron ulcer was injected with epinephrine and coagulated by a thermal probe.Following endoscopy, patient was transfused, and a repeat hemoglobin was 8.6.History of colonic arteriovenous malformation (1998) status post colonic resection of 40% colon.Fundoplication (1986) for a hiatal hernia with gastroesophageal reflux disease.Exam: abdomen: obese, nontender, soft, no masses, midline surgical scar.Weight 130 kg.Condition at discharge: stable.Follow up: with dr.(b)(6).On (b)(6) 2002: (b)(6) clinic.(b)(6).Procedure report.Indication: melena.Esophagogastroduodenoscopy.[procedure]: following the pre procedure patient assessment, the procedure, goals, risks, and alternative were reviewed.I attended the entire viewing portion of the procedure.The esophagus was intubated without difficulty using the therapeutic channel gastroscope.The esophagus was normal through its length with the squamocolumnar junction identified at 30 cm from the incisors.Direct and retroflexed views of the stomach demonstrated a loose nissen fundoplication with an apparent small paraoesophageal hernia.The diaphragmatic pinch, was a 0.5 cm healing ulcer form recent cautery.This ulcer had no stigmata of recent bleeding.The remainder of the stomach was unremarkable.There was in fact bilious material coating the gastric mucosa.The duodenal bulb and second portion of the duodenum were normal in appearance.In summary, no evidence for recurrent upper gi bleeding by endoscopic findings.The patient tolerated the procedure well.The patient was assessed upon completion of the procedure.[impression]: status-post loose nissen fundoplication with apparent paraoesophageal hernia.Status post cautery-induced ulcer proximal gastric fold in its healing stage.No presence of altered or fresh blood within visualized upper gi tract.On (b)(6) 2002: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct chest/abdomen.Indication: status post right chest well chondro resection.[impression]: in the abdomen, there is a hiatal hernia.Abdomen is otherwise negative.On (b)(6) 2002: (b)(6) clinic.(b)(6).Operative report.[preoperative diagnosis]: status post repair paraoesophageal hernia and nissen fundoplication years ago elsewhere.Status post partial colectomy.Recurrent paraoesophageal hernia.Recent massive gastrointestinal bleeding.Left post lateral thoracotomy.Redo repair paraoesophageal hernia with belsey fundoplication, thoracoabdominal approach.Assistant: (b)(6).Asa iii.Drainage: 2 chest tubes.[procedure]: ¿the patient was brought to the operating room in satisfactory condition.Under general endotracheal anesthesia with a double-lumen endotracheal tube, the patient was placed in the lateral decubitus position, prepared and draped in the usual fashion.A left posterolateral thoracotomy incision was made, and the left pleural cavity was entered over the top of the nonresected eighth rib.Exploration of the pleural cavity revealed no free pleural fluid.There was no mass or nodularity of the parietal pleura or the patient¿s lung.The inferior pulmonary ligament was mobilized.There was a modest-sized paraoesophageal hernia present.Dissection of the esophagus was begun posteriorly.Mediastinal pleura opened and dissection carried to above the level of the azygos vein.Dissection was then begun anteriorly in back of the pericardium.Care was taken to protect both the esophagus and both vagus nerves, which were clearly identified.The mobilization of the esophagus continues up to about the level of the aortic arch.Attention was then directed to the crura where a very tedious dissection ensued mobilizing the wrap, which had obviously herniated into the pleural cavity.Dissection was completed on the left side of the crura and then continued posteriorly.The left lobe of the liver and caudate lobe were identified.They were densely adherent to the underside of the diaphragm.I was able to mobilize the wrap for 360 degrees.I was not, however, able to enter the free abdominal cavity nor the lesser sac.A counter incision was then made in the diaphragm in a curvilinear fashion so as to protect the phrenic nerve.The spleen was encountered and was densely adherent to the underside of the diaphragm.Again, a very tedious dissection of the abdomen was required.I was eventually able to mobilize a portion of the patient¿s colon, the omentum, the spleen, and identify a portion of the greater curvature of the stomach.Several short gastric vessels were ligated with 2-0 silk suture.The anterior surface of the stomach identified and dissection carried beneath the lateral segment of the liver.I was able to enter the lesser sac somewhere in the region of the midbody of the stomach and finally accomplish a 360-degree mobilization of the esophagus, the wrap, and the body of the stomach.I was able to bring the entire wrap now up into the chest.A nissen fundoplication was present.I could not tell whether the wrap was on the true esophagus or stomach.I therefore took the wrap down.The fundus of the stomach was clearly viable.A 50 french bougie dilator had been in place.Both vagus nerves were intact.I then proceeded with a belsey fundoplication.Crural stitches were placed, first reapproximating the crura with 0 prolene suture place in a figure of eight fashion.The belsey fundoplication was then done in the usual fashion using three 2-0 prolene sutures approximating stomach to esophagus.These went from vagus nerve to vagus nerve.Care was taken to protect the vagus nerves.A second layer of sutures was then placed and the wrap then imbricated beneath the diaphragm.Upon completion of the belsey wrap, the wrap was intact without undue tension.The stomach and gastroesophageal junction lay in the abdominal cavity nicely.The crural stitches were then closed with a 50-french bougie dilator in place.The belsey fundoplication had been done with a 50- french bougie.Upon completion of the crural repair, the crura were intact without undue tension.Hemostasis was found to be secure.The bougie was removed under direct vision and a nasogastric tube placed.The abdominal cavity was irrigated with dab¿s solution because of the patient¿s previous history of mrsa infections.The diaphragm was then closed with interrupted no.1 prolene suture placed in a figure-of-eight fashion.The chest cavity was also irrigated with dab¿s solution.The lung expanded nicely to fill the pleural space.A single 32-french straight and 32-french right angle chest tube placed, and the wounds were then closed in the usual fashion with multiple layers of vicryl suture.The skin was reapproximated with skin clips.The patient tolerated the operative procedures well, left the operating room in satisfactory condition.¿ on (b)(6) 2003: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct chest/abdomen.Indication: status post belsey fundoplication.[impression]: since (b)(6) 2002 the hiatal hernia has been surgically repaired.There is no evidence or recurrent hiatal hernia.Atelectasis both lung bases.Examination is otherwise negative.On (b)(6) 2004: (b)(6) clinic.(b)(6).Operative report.[preoperative diagnosis]: right flank hernia.Stoppa repair with composix mesh of right flank hernia (943ind178, 123114, mesh composix 10x14in, bard medical division).Drainage: 2 blake drains.Complications: none.Disposition: to recovery.Drains: round blake times two.Asa ii.[procedure]: ¿the patient was brought to the operating room.General anesthesia was induced.He was placed in a left lateral decubitus position.After general anesthesia was induced, preoperative antibiotics were given due to his history of mrsa infection.The skin was prepped and draped in the usual fashion.The old incision along his right costal margin, where his chondrosarcoma had incised, was opened.The scar was excised.We carried down this dissection to the thoracic and flank wall.There was a sizable defect (20 x 30 cm) and a good deal of weak muscle and fascia.We undermined the skin in all directions to expose the edges of this defect.We then realized that the liver was actually making up part of the hernia sac, so we entered the peritoneal cavity to free up the thoracic cage and abdominal wall musculature form the underlying structures.Adhesions were minimal and were easily lysed.At this time, we placed a large piece (12 x 12¿) of composix mesh with the ptfe side facing the bowel.This was sutured in place with no.1 pds u-stiches superiorly, and laterally these went through the costal or around the rib margins, and medially trying to include the periosteum of the rostral rib margin and inferiorly they went through the abdominal wall down to just above the iliac spine and approaching the midline.Medially and inferiorly, there were brought out transmurally through the skin and tied through separate stab incisions.Posteriorly and superiorly, they were brought out underneath the skin flap.The mesh was snug without tension.The wound here was irrigated with 2 l of neomycin irrigation.The fascial defect over top of the mesh was closed with a running 0 vicryl, after two drains were placed on top of the mesh and brought out through separate stab incisions and sutured in place with prolene suture.The wound then was irrigated again with saline and neomycin, and the skin was closed with a subcuticular suture.All the transmural stitch sites were closed with staples, and the skin incision was reinforced with staples.The patient tolerated the procedure well and was taken to recovery in stable condition.¿ on (b)(6) 2004: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct chest/abdomen.Indication: soft tissue primary.[findings]: there is a peripherally enhancing complex fluid collection in the right upper quadrant measuring approximately 14.3 cm x 4.5 cm x 12.5 cm.The fluid collection has a few internal loculations and multiple regions of air and is consistent with an abscess.There is a large amount of surrounding increased attenuation and soft tissue thickening consistent with inflammation and edema.It is difficult to evaluate for soft tissue recurrence of the patient¿s known malignancy because of this and repeat imaging after resolution of the abscess cavity would be helpful.Post-operative changes to the right chest wall and right lung.Mild fibrosis or atelectasis left lung base.Calcified left hilar lymph nodes.Old left thoracotomy with post-op changes and fibrosis in the left lung base.Fibrosis in the right lung base.Normal sized lymph nodes in the right axilla.Remainder of the examination is negative.Findings were discussed with dr.(b)(6).On (b)(6) 2004: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct abdomen w/ pelvis.Indications: abscess intra abdomen, check size of abscess cavity.[findings]: postoperative changes resection of a portion of the right abdominal wall and multiple right ribs.In this area there is a right percutaneous drainage catheter draining an abscess cavity.There is high density material within the cavity which is likely contrast from a sinogram obtained earlier today.Compared to prior ct (b)(6) 2004 this abscess cavity is smaller today.It is difficult to determine whether this is recurrence in this area with all of the surrounding inflammatory changes in this region.There are some lymph nodes in the region of the port hepatis anterior to the inferior vena cava.They appear slightly enlarged but not changed compared to (b)(6) 2004.Ct abdomen and pelvis otherwise negative.On (b)(6) 2004: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct chest/abdomen.Indications: rule out undrained fluid collection, drain if needed.[findings]: there is a 1.8 x 4.5 cm intra-abdominal air and fluid collection interposed between the lateral edge of the inferior right hepatic liver and the right abdominal wall abscess cavity.This may represent intraperitoneal extension of the abscess.The air and fluid collection does not opacify with contrast.Resection of multiple right inferior ribs.Inflammatory mass in the right flank superficial to the drained abscess cavity has increased in size compared to the 5/21/04 examination.This inflammatory mass also does not opacify with contrast.Right hemicolectomy.Right axillary adenopathy is stable.On (b)(6) 2004: (b)(6) clinic.(b)(6).Operative report.Preoperative diagnosis: enterocutaneous fistula.Preoperative indication: increased output from fistula.Postoperative diagnosis: infected right flank composix mesh.Enterocutaneous fistula.Exploration of right flank hernia.Removal of infected mesh.Closure.Assistant: (b)(6).[procedure]: ¿patient was brought to the operating room 108 and placed in the left semidecubitus lateral position.After general anesthesia was induced, preoperative antibiotics were given due to patient¿s history of mrsa infection.The skin was prepped and draped in the usual sterile fashion.The old incision along his right coastal margin was incised and the dissection carried down to the mesh.The mesh was incised in the middle and place was developed underneath the mesh between the infected mesh and the pseudo capsule underneath.Subsequently, flaps were developed superiorly, inferiorly, laterally, and medially on top of the mesh to all edges.Several prolene stitches were cut at the perimeter of the mesh.Subsequent to that, the mesh was removed form the pseudocapsule below and ingrown scar tissue above in completion.The wound was irrigated copiously and inspected carefully.At the left lower corner of the wound, there appeared to be a small defect in the pseudocapsule.Underneath, the soft tissue was visualized which potentially could be bowel.No enterotomy was made, however.No enteric content was seen at the time of surgery at any point.We did not see the enterocutaneous fistula.Pseudocapsule was intact in the remainder of the base of the wound.Hemostasis was complete.The drain was pulled out through the wound.Hemostasis was complete.The wound was packed with two large kerlixes.An abdominal binder was placed on the patient.The patient tolerated the procedure well and was transferred in stable condition to pacu.¿ on (b)(6) 2004: (b)(6) clinic.(b)(6) , md.Pathology.Tissue description: material from abdomen (mesh 28.0 x 24.0 cm; soft tissue 13.5 x 5.4 x 1.3 cm).Diagnosis: abdominal wall, excision mesh: mesh with attached fibrous tissue.On (b)(6) 2004: (b)(6) clinic.(b)(6) , md.Discharge summary.Summary diagnosis: infected right flank hernia mesh.Enterocutaneous fistula to the right flank wound.Admitted: (b)(6) 2004.History of resection of chondrosarcoma on (b)(6) 2001 with placement of gore-tex mesh in right flank area.Subsequently, mesh had infection with mrsa and required to be removed.Patient had repeat hernia repair stoppa on (b)(6) 2004 which was complicated by wound infection and required drain placement for intra-abdominal abscess.Ct showed a communication of cavity with small bowel.Hospital course: on (b)(6) 2004 performed incision of right flank area and removal of infected mesh and wound packing.Postoperatively day 2, the enterocutaneous fistula was patent into the bed of the wound.Treated conservatively with wound packing using wet-to-dry kerlix.Patient tolerated wound dressing changes without complications.Condition at discharge: stable.Ongoing care: dressing changes.Not to lift anything greater than 10 pounds until further notice.Follow up at (b)(6) (b)(6) 2004.On (b)(6) 2004: (b)(6) clinic.(b)(6) , md.Radiology ¿ ct abdomen/chest.Indications: cancer lung.[findings]: there is tiny sliver of fluid of residual soft tissue thickening around the liver laterally.No extraluminal contrast is seen, but loops of small bowel are immediately adjacent to the defect in the right lateral abdominal wall just lateral to the liver.The inflammatory change in the right lateral abdominal wall has decreased.Right hemicolectomy.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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 material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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