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| Model Number 1320030020 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/06/2015 |
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Event Type
Injury
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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: relevant medical information: on (b)(6) 2009: (b)(6) hospital.(b)(6) operative report.Preoperative diagnosis: recurrent diverticulitis with microperforation.Postoperative diagnosis: recurrent diverticulitis with microperforation.Procedure performed: intraoperative colonoscopy.Laparoscopic-assisted sigmoid colon resection.Complications: none.On (b)(6) 2009: (b)(6) radiology ¿ ct abdomen/pelvis with contrast.Indication: oozing from incision site.Impression: postsurgical changes in sigmoid colon.Moderate amount of free air within abdomen and pelvis, consistent with probable perforation at surgical site, with trace free fluid in the pelvis.No definite abscess collection seen.Small irregular collection of fluid in the subcutaneous tissues deep to the incision line; may represent a tiny seroma or abscess.On (b)(6) 2009 [assigned]: (b)(6) history and physical.Abdominal wall cellulitis.Recently hospitalized for laparoscopic sigmoid colectomy for severe diverticulosis with diverticulitis.History of chronic obstructive pulmonary disease, obesity and borderline diabetes.Reports at home she had been feeling well, eating and having normal bowel function but has noticed increased pain and redness around her incision.Presented to the emergency department, noted elevated white count and ct scan which shows a subcutaneous fluid collection as well as possible intraabdominal free air.Medical history: gastroesophageal reflux disease.Nonsmoker.Abdomen: soft, warmth and erythema around her incision.No crepitus or evidence of subcutaneous air.Abdomen is soft without any evidence of acute abdomen on exam.Impression/plan: subcutaneous abscess, which i will plan to incise and drain.Additionally, there is question of possible anastomotic leak.Will place on intravenous fluid, intravenous hydration and admit her to be evaluated by (b)(6).Continue to follow through hospital course.On (b)(6) 2009 [assigned]: (b)(6).Operative report.Preoperative diagnosis: abdominal wall abscess.Postoperative diagnosis: abdominal wall abscess.Procedure: incision and drainage of abdominal wall abscess.Findings: a 3 x 3 cm cavity with purulent material was identified, drained and packed.On (b)(6) 2009: (b)(6).Radiology ¿ ct abdomen/pelvis without contrast.Impression: several primarily air-containing collections adjacent to a thick-walled sigmoid colon, consistent with contained focal areas of perforation.These are thin walled in appearance and do not yet have the appearance of mature abscesses.There is an air-contrast level within a small portion of the base of at least two of these areas.Significant free intraabdominal air seen on previous exam consistent with perforation.Abnormally thick-walled appearance of the sigmoid colon just proximal to the surgical clips and at level of leak.Multiple air bubbles within the subcutaneous fat of lower anterior abdominal wall, in the area of previously visualized fluid collection.May simply represent communication with the anterior abdominal wall incision.Felt less likely to represent an abscess.On (b)(6) 2009: (b)(6).Operative report.Preoperative diagnosis: rectosigmoid anastomotic leak.Postoperative diagnosis: rectosigmoid anastomotic leak.Procedure: exploratory laparotomy.Diverting colostomy.Findings: a low rectosigmoid anastomotic leak in the posterior aspect/well-contained initially on exploration by a walled-off loop of distal ileum.No gross spillage, no abscess, no purulent fluid, only small fibrinous coat associated with the focalized area walled-odd ileum.Pelvis otherwise clean, as is the rest of the abdomen.Complications: none.On (b)(6) 2009: (b)(6).Consultation.Had mild postoperative respiratory failure; resolved.Weight: (b)(6).Impression: postoperative with exploration laparotomy and colostomy with increased white cell count and most likely has peritonitis and subclinical sepsis may be present; will need further evaluation.Postoperative insufficiency most likely due to postoperative atelectasis.Comorbid issues.On (b)(6) 2009: (b)(6).Radiology ¿ fluoroscopic removal of drainage catheter in the pelvis, foreign body.Indication: inability to remove drainage catheter in the pelvis.Impression: successful uncomplicated drainage catheter removal from the pelvis.On (b)(6) 2010: (b)(6).Operative report.Postoperative diagnosis: diverticulitis.Procedure: insertion of bilateral ureteral stents.On (b)(6) 2010: (b)(6).Operative report.Preoperative diagnosis: colostomy.History of perforated diverticulitis with pelvic abscess.History of colorectal anastomotic leak with pelvic abscess.Postoperative diagnosis: colostomy.History of perforated diverticulitis with pelvic abscess.History of colorectal anastomotic leak with pelvic abscess.Intraoperative right ureteral injury.Procedure: low anterior resection with proximal rectal stump excision.Takedown and reversal of end colostomy.Extensive lysis of adhesions over 2 ½ hours, (modifier 22).Diverting brooks¿ end loop ileostomy.Rigid proctoscopy.Complications: right ureteral injury.¿note, down the pelvis was placed some seprafilm.Also around the loop of the small bowel that was being pulled through the body wall also had a small amount wrapped of seprafilm so that it would be easy to mobilize when it was taken down.¿ on (b)(6) 2010: (b)(6).Operative report.Preoperative diagnosis: ureteral injury.Postoperative diagnosis: ureteral injury.Procedure: right ureteroneocystostomy with stent placement.Indications: this is a (b)(6) woman who in the course of an abdominal operation by (b)(6) underwent a ureteral injury in the very distal ureter.It should be noted that the patient had a frozen pelvis and made surgery extraordinarily difficult.The ureter was apparently adhered to all the surrounding structures and despite the presence of preoperative stents underwent an injury.On (b)(6) 2010: (b)(6).Discharge summary.Admitted (b)(6) 2010.Discharge diagnoses: history of a rectosigmoid anastomotic leak.History of perforated diverticulitis with pelvic abscess.History of diverting end colostomy for rectosigmoid anastomotic leak.Right ureteral iatrogenic intraoperative injury.History: approximately a year and a half ago, developed a perforated diverticulitis with a pelvic abscess; drained by ct-guided drainage.Managed to be treated nonoperatively, then had it taken out as an elective sigmoid colon resection.This was performed initially without incident, however, approximately 6 to 7 days postoperatively, started developing perineal pain and found to have slight small pelvic abscess adjacent to anastomosis, which was shown to have a small leak.Required a resection of the initial anastomosis with diverting end colostomy.Also developed small postoperative, at the midline incision, an intracutaneous fistula which in 2 weeks spontaneously closed by itself, and she had been doing well from the overall surgery with the exception of some pain from excoriation of the skin approximately 2 to 3 cm lateral to the colostomy site from her appliance.Otherwise, was doing well and then was set up 1 year later for reversal which was done.Hospital course: taken for operative management of day of admission.Tolerated procedure well; it was fairly lengthy.Postoperatively, taken to intensive care unit for initial recovery and maintenance of fluid shifts due to the degree of length of surgery and the degree of dissection and lysis of adhesions with the expectation of a great deal of third space fluid mobilization.Did very well initially, because of ileostomy, on postoperative day 3 nasogastric tube removed; stared on clear liquids.By postoperative day 5, starting to have flatus in ileostomy bag; diet slowly advanced.By postoperative day 7, put on regular diet and by postoperative day 8, the bridge for the ileostomy was removed and she was feeling well.Incision sites for both the midline and her ileostomy takedown site looked good with no erythema.No pain issues, ambulating.Still had a foley; keep for 1 week before being removed by dr.(b)(6).Instructions: follow up dr, (b)(6) in approximately 7 days; call for appointment.Ambulate frequently, stay active, no heavy lifting over 15 pounds for 6 weeks.Plan is that in about a month, will reverse brooks ileostomy as a final procedure.On (b)(6) 2010: (b)(6).Radiology ¿ ct abdomen/pelvis without intravenous contrast.Indication: fever, status post colectomy.Impression: there has been removal of the stoma device in the left mid abdomen and a new one just to the right of midline.There are inflammatory changes with some gas bubbles on removed stoma site to left of midline.Mesenteric thickening or inflammatory changes anterior and superior to the urinary bladder.Double-j ureteral stent is seen in place on the right.A 1.5 cm diameter benign appearing cyst left kidney.No other definite abscess seen.(b)(6) 2010: (b)(6).Operative report.Preoperative diagnosis: history of perforated diverticulitis.History of anastomotic leak.Postoperative diagnosis: history of perforated diverticulitis.History of anastomotic leak.Procedure: an end (brooke) ileostomy takedown and reversal.Complications: none.On (b)(6) 2010: (b)(6).History and physical.Abdominal pain with significant prior abdominal surgery history.Complains since last week of on and off abdominal pain that she felt was possible ventral incisional hernias.Nausea today.Surgical history: laparoscopic cholecystectomy, appendectomy.Abdomen soft, nondistended.There is focal tenderness in the periumbilical location; no guarding or peritoneal signs, no rebound.Question ventral incisional hernia defect, but difficult to tell due to obesity.Midline well-healed scars from incision sites starting at umbilicus down to xiphoid as well as 2 transverse incisions below the level of the umbilicus from prior ostomy takedown sites bilaterally.Plan: ct abdomen/pelvis with contrast to evaluate for ventral incisional hernias and to rule out small bowel obstructions, possible abdominal operative treatment if, necessary in next 24 hours.On (b)(6) 2010: (b)(6).Radiology ¿ ct abdomen/pelvis with contrast.Indication: mid-abdominal pain.Impression: interval takedown of right lower quadrant ostomy.Small ventral abdominal hernia in area with loop of nondilated small bowel, no evidence of obstruction.Postoperative changes along the colon without evidence of active diverticulitis.A focal region of wall thickening versus under distention seen in proximal transverse colon as described above.Fatty liver.On (b)(6) 2010: (b)(6).Radiology ¿ abdomen series with chest.Impression: no free air or bowel obstruction.No infiltrates.Implant #1 procedure: ventral incisional hernia repair with mesh (15 x 20 cm gore-tex dual mesh).Lysis of adhesions (1 hour).Implant: gore-tex® soft-tissue patch [1315020020/7024489, 15 x 20 cm] implant #1 date: (b)(6) 2010 (hospitalization (b)(6) 2010).On (b)(6) 2010: (b)(6).Operative report.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: ventral incisional hernia.Assistant: dr.(b)(6).Anesthesia: general endotracheal anesthesia.Estimated blood loss: less than 50 cc.Specimen: none.Findings: ventral incisional hernia at the midline of the periumbilical region and multiple fascial holes connected by scar and hernia sac material.The overall defect after being cleaned up was an 8 x 10 cm fascial defect.Complications: none.Condition: stable.Description of procedure: ¿it was discussed with the patient the risks, benefits and alternatives of procedure.The patient indicated understanding and chose to proceed.All questions answered, consent obtained.The patient had sequential compression devices placed to lower extremities and given 2 g of ancef iv.She was taken to the operative room, placed in supine position.General anesthesia was induced.Endotracheal intubation was performed.Patient's abdomen was prepped in the usual sterile manner.Sterile towels and sterile drapes were applied.An ioban was placed.A sharp incision starting around the periumbilical region over the old midline incision was made sharply.Dissection was taken down to subcuticular tissues and scar tissue down to the fascial defect.The fascial defect was then cleared out circumferentially initially down to the normal fascia and the scar tissue was debrided back, and some of the hernia sac away from the fascial defect.As this was done also a significant amount of adhesions of both neosigmoid/transverse colon and small bowel adherent to the anterior abdominal wall, were carefully taken down sharply with metzenbaum scissors without any serosal injury or tears or any bowel injury.The bowel was healthy and viable after the complete lysis of adhesions circumferentially to the anterior abdominal wall.There was good hemostasis throughout the procedure.The anterior fascia of the defect was then cleared off in a 3-4 cm radius.The umbilical stalk had to be un-implanted because it was adherent to scar tissue and part of the hernia sac and was cleared off as well during this surgery.Next, a 15 x 20 cm piece of dual gore-tex mesh was obtained and soaked in double antibiotic irrigation fluid.It was cut to a rounded ellipse.Corner stitches using through and through #1 prolene suture was placed with stay sutures and tagged at all 4 quarter points and the mesh was then placed in its appropriate position posterior to the defect.The gaps in between were then closed with numerous 5 mm apart placed interrupted through and through #1 prolene sutures.Once these were all placed on 1 side of the abdominal defect, the tagged sutures were then tied down to the fascia snugly.Once this was placed, this was started first on the right side and next the left side was approached in a similar manner, and sutures were placed circumferentially and again sutured down.This allowed for good placement of mesh without tension but not overly loose and without redundancy.There were no defects between the mesh and the fascia after all the sutures has been snugly tied down.Double antibiotic irrigation fluid was placed and the fluid aspirated showed to be clean, and all the walls hemostatic.Two-thirds of the fascial defect was closed over the mesh without any tension, the last third was left open, otherwise it would have been under tension but it closed up most of the fascial defect over the mesh covering it.The stalk of the umbilicus base was then sutured down to the underlying fascia with two interrupted figure-of-eight 3-0 vicryl sutures.Scarpa¿s fascia reapproximated with a running 2-0 vicryl suture and the skin was reapproximated superficially with a running subcuticular 3-0 monocryl suture.Steri-strips were placed and a bandage was applied.The patient was put into an abdominal binder.She was then allowed to recover from anesthesia, extubated in the operating room, and taken to pacu for full recovery of anesthesia.¿ on (b)(6) 2010: (b)(6).Implant sticker.Gore-tex® soft tissue patch.Ref catalogue number: 1315020020.Lot batch code: 7024489.W.L.Gore & associates.[handwritten] expiration: 08/26/2014.The records confirm a gore-tex® soft-tissue patch (1315020020/7024489) was implanted during the procedure.Relevant medical information: on (b)(6) 2010: (b)(6).Discharge summary.Discharge diagnosis: ventral incisional hernia and abdominal pain.Procedure performed: a ventral incisional hernia repair with mesh, with lysis of adhesions.(b)(6) woman with significant history including 4 prior abdominal operations that were very extensive.Developed increasing fairly rapid ventral incisional hernia with increasing sized and growth of midline ventral prior incisional sites and scar sties.Caused discomfort, nausea and pain over a short period of time.Admitted through emergency room, having initially been scheduled to be seen end of this week in office for elective procedure.Fairly obese and difficult to examine, but did feel obvious fascial defects on the hernias at the midline lower abdomen at the level of the umbilicus and just to the right of the umbilicus with some discomfort on palpation.Within a few hours after admission, ventral incisional hernia repair with mesh was performed.Tolerated procedure very well, no complications.The bowel and underlying adhesions around the site of the hernia were healthy with no enterotomies, serosal tears or injury and she did very well postoperatively.Following surgery, admitted back to the surgical floor and on postoperative day 1 was ambulating and moving, started on clear liquids and was slowly advanced but no passing flatus.Postoperative day 2, passing flatus, getting up better, having better pain control with no nausea and tolerating soft diet; discharged home.Binder in place.Incision looked clean, dry and intact prior to discharge.Follow up (b)(6) in approximately 10 days in office.Ambulate frequently, stay active, wear abdominal binder most of the time, particularly when active.Instructed not to do any heavy lifting over 15 pounds or anything strenuous for next 6 weeks.Discharge medications: percocet, colace, dulcolax.On (b)(6) 2010: (b)(6) radiologists.Radiology ¿ ct abdomen/pelvis with contrast.Indication: left lower quadrant bulge.Findings: prior mesh repair of ventral hernia.To left of mesh, there is a defect in the abdominal wall with neck diameter of 2.0 cm.This most likely represents palpable abnormality within the left lower quadrant.Soft tissue stranding anterior to mesh, possibly postoperative scarring.Impression: new left anterior abdominal hernia, adjacent to the mesh, containing fat only.Stranding anterior to the mesh from prior hernia repair most likely represents chronic scarring.On (b)(6) 2010: (b)(6).Operative report.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: ventral incisional hernia.Procedure: ventral incisional hernia repair with mesh (ventralex 2.5 in diameter).Assistant: (b)(6).Anesthesia: general endotracheal anesthesia plus 30 ml of 0.5% marcaine with epinephrine for local.Estimated blood loss: less than 10 ml.Specimens: none.Findings: there were 2 adjacent fascial defects left of the midline just inferior to the left colostomy closure site.The 2 defects were approximately 1 cm apart with the medial defect 1 cm in diameter and the lateral defect 1.5 cm in diameter, divided by muscle and fascial standing tissue.Complications: none.Condition: stable.Description of procedure: ¿it was discussed with the patient the risks, benefits, and alternatives of the procedure, and the patient indicated understanding and chose to proceed.All questions were answered, and consent was obtained.The patient received antibiotics preoperatively, and sequential compression devices were placed on the lower extremities.She was given 1 g of ancef preoperatively and then taken to the operative room and placed in the supine position.General anesthesia was induced.Endotracheal intubation was performed.The patient¿s abdomen was prepped in the usual sterile manner.Sterile towels, ioban, and sterile drapes were applied.A sharp incision was made transversely along langer lines approximately 2 cm paralleling and 2 cm below the ostomy closure site on the left side.This was approximately a 4 cm incision.Dissection was taken down through subcuticular tissues and fatty tissue and scarpa fascia down to the palpable fascial defect.The small hernia sac was dissected out circumferentially, and the fascia was cleared, identifying a second fascial defect just medial to the main defect.The hernia sac was excised out and discarded.The fascia was cleared off anteriorly over both defects.The mild small amount of adhesions inferior to the posterior abdominal wall were then carefully cleared away with either metzenbaum scissors or with digital dissection.There was good hemostasis.The medial small fascial defect was closed with 2 figure-of-eight 0 prolene sutures with no tension.Next, a medium-sized or 2.5-inch diameter ventralex mesh was obtained and allowed to soak for 10 minutes in double antibiotic irrigation fluid.In 4 corners, it was sutured with through-and-through buttonhole sutures using interrupted 0 ethibond suture to 4 quadrants, which were tagged as they were placed and then, once all 4 corner sutures were in, the mesh was then parachuted down posterior to the fascial defect, specifically behind the defect, and then pulled up.Between each corner suture, the stitches were then divided with 4 more buttonhole sutures using interrupted 0 ethibond for a total of 8 sutures to the mesh and once they were all placed, all of the tag sutures were then snugly tied down.There was no spaces or gaps between the mesh and the posterior wall of the defect.The mesh covered underneath both fascial defects.The larger defect was then closed primarily with a running 0 prolene suture over the mesh covering it.This was done without tension.Local anesthetic was infiltrated liberally in both the deep subfascial tissues and more superficial subcuticular and subdermal tissues liberally.There was good hemostasis.Double antibiotic irrigation was used to wash out the surgical site, and again, it was shown to be clean and hemostatic.The scarpa fascia was reapproximated with a running 2-0 vicryl suture, and the skin was reapproximated superficially with a running subcuticular 3-0 monocryl suture.Steri-strips were placed, and a bandage was applied.The patient was allowed to recover from anesthesia, extubated in the operating room, and taken to the post anesthesia care unit for a full recovery of anesthesia.¿ on (b)(6) 2010: (b)(6).Implant sticker.Bard ventralex hernia patch.Implant #2 procedure: reduction and repair of an inferior midline abdominal wall incarcerated ventral incisional hernia with mesh.Reduction and repair of a left abdominal wall incarcerated ventral incisional hernia with mesh.Implant: gore-tex® soft-tissue patch [1320030020/05803966.] implant #2 date: (b)(6) 2011 (hospitalization).On (b)(6) 2011: (b)(6).Operative report.Preoperative diagnosis: left abdominal wall incarcerated ventral incisional hernia.Midline inferior abdominal wall incarcerated ventral incisional hernia.Postoperative diagnosis: left abdominal wall incarcerated ventral incisional hernia.Midline inferior abdominal wall incarcerated ventral incisional hernia.Assistant: (b)(6).Anesthesia: general endotracheal anesthesia plus 30 ml of 0.5% marcaine with epinephrine for local.Estimated blood loss: less than 40 ml.Specimen: x2 ventral incisional hernia sacs.Findings: there was a low midline or inferior midline incisional hernia of approximately 5 x 4 cm with incarcerated a small amount of colon and omentum within it.Left abdominal wall showed a 4 x 3 cm fascial defect with fatty tissue and omentum within it.Complications: none.Condition: stable.Description of procedure: ¿it was discussed with the patient risks, benefits, and alternatives to the procedure.The patient indicated understanding and chose to proceed.All questions were answered.Consent obtained.The patient received 1 g of ancef preoperatively and sequential compression devices placed to lower extremities.She was taken to the operative room and placed in the supine position.General anesthesia was induced.Endotracheal intubation was performed.The patient¿s abdomen was then prepped in the usual sterile manner.Sterile towels and ioban and sterile drapes were applied.Starting at the midline site, going through her old midline incision inferiorly, a sharp incision was made infraumbilically of approximately 4-5 cm in length.Dissection was taken down to subcuticular tissues and scar tissue down to the hernia sac.The hernia sac itself was grasped with a babcock and then dissected out, and then dissected away from the surrounding scar tissue and preperitoneal fat down to the fascial defect.It was then incised circumferentially and removed with adhesions taken away from underlying adhesions to omentum with easy reduction of colon within this tissue.Superiorly, the tissue between an old mesh more superiorly placed at the midline to the superior fascia was very tenuous and thin, therefore, it was cleaned off all the way down to the old mesh superior aspect of the fascial defect.All adhesions circumferentially were very carefully released at least 3-4 cm circumference relative to the fascial defect.Anterior adhesions, scar tissue, and subcuticular tissue were cleared off the fascia in a 3 cm radius from the fascial defect.Once this was _____ [sic], this was left in place and the next hernia site was set to be dissected out.A sharp incision was made going through an old left-sided ostomy takedown site sharply of approximately 4 cm.Dissection was taken down through this transverse incision down through the subcuticular fat and scar tissue with electrocautery to a hernia sac, which was grasped with a babcock and then dissected out circumferentially, and then the hernia sac was incised and removed.Underlying adhesions were carefully freed up sharply or with blunt dissection.Adhesions circumferentially for a 3-4 cm radius were freed up of omentum and small bowel on the underside of the fascia just lateral to the defect.Superiorly and inferiorly, you could palpate the prior mesh placement from a prior hernia repair as well, which was a small disk of an old ventralex.It was well incorporated.Superiorly throughout the defect, there were 2 more small holes adjacent to each other of 7 mm and 10 mm.They were carefully connected, and the tissue in-between them and the main fascial defect were also connected with a bridge of tissue that was removed due to its tenuous nature and inability to close without the potential new hernia formation.Once these were combined to form 1 straight hernia 4 x 3 cm in dimension, the anterior leaf of fascia was cleared off circumferentially for a 3 cm radius.Next, both of these, a large piece of gore-tex mesh was obtained that had been soaking for nearly 30 minutes in double antibiotic irrigation.2 large pieces of mesh circular in shape were cut from this main piece in order for the repair and to allow for a 2-3 cm margins easily without closure of these defects loosely and without tension.This was done ______[sic] on either site.The mesh was pulled through in a posterior manner with through-and-through buttonhole stitches at all 4 corners using 0 prolene suture.Each corner placement stitch was then divvied up with 3 other sutures and pulled forth.These were tagged as they were placed until all sutures were incorporated individually.The left abdominal wall defect was then closed in this manner and all the sutures were tied down snugly and the overlying fascial defect could be closed without any tension at all with more interrupted 0 prolenes were to cover the mesh.This was performed for both hernia and fascial defect sites.The area was irrigated thoroughly with double antibiotic irrigation.Fluid aspirate was shown to be clean and the wound bed hemostatic.Local anesthetic was infiltrated liberally in all surrounding tissues deep and superficial.The scarpa fascia and scar tissue was reapproximated loosely over this tissue with running 3-0 vicryl sutures on both wound sites, and the skin at both incision sites reapproximated with running subcuticular 4-0 monocryl suture.Steri-strips were placed and bandages were applied.The patient was put into an abdominal wall binder.The patient was then allowed to recover from anesthesia, extubated in the operating room, and taken to pacu for full recovery of anesthesia.¿ on (b)(6) 2011: (b)(6).Operative note.[illegible] and repair of incarcerated ventral incisional hernia times two (with mesh, goretex #2).On (b)(6) 2011: (b)(6).Implant sticker.Gore-tex® soft tissue patch.Ref catalogue number: 1320030020.Lot batch code: 05803966.W.L gore & associates.The records confirm a gore-tex® soft-tissue patch (1320030020/05803966) was implanted during the procedure.Relevant medical information: on (b)(6) 2011: (b)(6).Surgical pathology report.Accession #: (b)(4).Specimen source: hernia sac, midline, res.Hernia sac, l abdominal wall, res.Diagnosis: soft tissue, midline ventral area, resection: fibrofatty tissue consistent with hernia sac.No unusual structures, atypia, or malignancy.Soft tissue, left abdominal wall area, resection: fibrofatty tissue consistent with hernia sac.No unusual structures, atypia, or malignancy.Clinical information: preoperative diagnosis: ventral incisional hernia x2.Gross description: labeled ¿(b)(6); midline hernia¿ is a saccular portion of tan pink fibromembranous tissue with attached lobulated fatty tissue, 7.0 x 4.5 x 1.3 cm.Serially sectioned.No discrete masses, lesions, or nodules are noted.Labeled ¿(b)(6); left abdominal wall hernia sac¿ is a portion of tan pink fibromembranous tissue with attached lobulated fatty tissue, 4.0 x 2.0 x 1.0 cm.Serially sectioned.No discrete masses, lesions, or nodules are noted.Microscopic description: microscopic examination was performed on each specimen submitted.On (b)(6) 2015: (b)(6).History and physical.Has undergone several abdominal operations, including ventral incisional hernia repairs.Reports some bulges that have formed in low to periumbilical abdomen that when she sits or strain causes pain.Denies obstructing symptoms.Abdomen: mass when sitting up or performing a ¿crunch¿ maneuver just inferior to umbilical and immediate left of midline near scar; to right of umbilicus is also small 1.5 cm bulge.Obese body habitus.Non-distended, midline as well bilateral lower quadrant transverse scar/incisions present.Hernias: 3 adjacent fascial defects, reducible, close proximity.Impression: obesity.Recurrent ventral incisional hernia times three; reducible.Plan: recurrent ventral incisional hernia repair with mesh.
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2010 and (b)(6) 2011 whereby a gore-tex® soft tissue patch 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: infection [multiple seedings], explant "3 gore devices.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged it should be noted that the gore-tex® soft tissue patch 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-tex® soft tissue patch 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.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-tex® soft-tissue patch instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ the instructions for use further state: ¿for best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.¿these may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.¿the above inherent risks are typically detailed in standard informed consent documents.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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