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| Model Number 1DLMC08 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling (2091)
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| Event Date 10/14/2013 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore® dualmesh® 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".
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Event Description
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It was reported to gore that the patient underwent open umbilical and ventral hernia repair on (b)(6) 2013, whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2013, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of mesh, additional surgery, cellulitis, abscess on abdominal wall, pain.Additional event specific information and medical records have been requested.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.
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Manufacturer Narrative
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A4: corrected patient's weight b7: added patient medical history h6: changed patient code 2091 (swelling) to 1768 (cellulitis) 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: records prior to (b)(6) 2013 , including records for the ¿previous surgery for an umbilical hernia that was repaired and dehisced¿ and ¿previous placement of a type of bard or marlex mesh¿ as noted in the (b)(6) 2013 records, were not provided.Operative records dated (b)(6) 2013 state the patient underwent ¿exploratory laparotomy with lysis of multiple adhesions to the abdominal wall, followed by repair of a large ventral and also recurrent umbilical hernia, large and also reinforcement repair with a large mesh of gore-tex.¿ ¿the patient is 52 years old who has a history of morbid obesity, diabetes type 2, also hypertension.The patient also has varicose veins and is at risk for deep vein thrombosis and also for complications like pulmonary embolism.Prior to this admission the patient underwent extensive evaluation to rule out any possible complications.The patient was seen by cardiologist¿who cleared the patient for procedure.¿ preoperative diagnoses: ¿morbid obesity, diabetes mellitus, hypertension, varicose veins, large ventral hernia, and also umbilical hernia.¿ findings from the (b)(6) 2013 procedure state: ¿large ventral hernia, also incisional hernia, recurrent from the recurrent [sic].Also we found that the patient part of the mesh that was implanted in the lower abdomen around the umbilical for reinforcement.For the repair we used gore-tex mesh that measured about 10 inches wide and about the 18 inches long.This mesh was used to reinforce the repair.¿ the (b)(6) 2013 operative report states: ¿we made an incision from the xiphoid around and just below the umbilicus through the midline.Carefully we started the dissection of the subcutaneous tissue.Keeping in mind that because of the lovenox the patient will tend to bleed, for that reason the hemostasis was very critical as we progressed in the dissection.The subcutaneous was completely open and then we reached the midline and we were able to open the midline of the abdomen at the linea alba.As we dissected we found that there was a large ventral hernia with also separation of the rectus muscles, plus also there was a hernia around the umbilicus on the right side of the umbilicus and these.In this area we found there was significant scar because of the previous placement of a type of bard or marlex mesh.The division was done, we opened the sac and we proceed to enter the abdominal cavity.¿ the (b)(6) 2013 operative report continues: ¿we entered the abdominal cavity, we made sure there was no incarceration of omentum or bowel.The bowel was not involved, but there definitely was involvement attachment of the omentum to the umbilicus as well as also to the omentum and bowel that were divided.These adhesions were divided and tied with ligature of 3-0 vicryl to avoid postop bleeding.Once this was completed we were able to clean and release all the adhesions attached to the anterior abdominal wall.We were able to then developed a flap from the base of the wound laterally and superiorly-inferiorly.This was done in order to create a space for placement of the mesh.¿ the (b)(6) 2013 operative report states: ¿on each side of the wound the subcutaneous was detached from the mass from the abdominal wall fascia, at least 4-5 inches on each side.Similarly this was done on the top and the bottom of the incision, but after doing that completing and making sure that the hemostasis was satisfactory we proceeded to irrigate the abdomen, review the bowel, review also the incision.At that point, we proceeded to close the main incision using #1 vicryl running, but interrupted every 3 inches.Multiple sutures were placed and eventually the cavity was closed.Once the cavity once the main incision [sic] was closed then we proceeded to review the hemostasis of the subcutaneous aspect followed by tailoring of the mesh to the shape of the wound.The mesh was tailored into the space.¿ the (b)(6) 2013 operative report continues: ¿once the mesh was trimmed and tailored we proceeded to anchor the mesh using also a #1 gore-tex suture.Again, this was placed running, but interrupted in several areas.For this purpose we used mesh coverage.The mesh was completely attached to the fascia of the abdominal wall, this was followed by profuse irrigation, review hemostasis.Once it was completed we placed 2 jackson-pratt drains inside the incision and exteriorized from independent incision.The abdominal was closed by using 3-0 vicryl to the subcutaneous and then we proceeded to close the skin using multiple skin staples.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc08/11147519) was implanted.There was no mention of removal of the non-gore device in the records.Discharge summary records dated (b)(6) 2013 state: ¿the patient is a 52-year-old male who was admitted with a long history of about an 8 month history of abdominal pain, distention as well as also pain on lifting and straining.The patient had previous surgery for an umbilical hernia that was repaired and dehisced.Also, the patient has a large ventral hernia.The patient suffers from morbid obesity, and for that reason he underwent an extensive preop evaluation which includes cardiac and also respiratory evaluation and clearance.The patient had a pulmonary function test.Also, the patient had an echo stress.Also, initially the patient has a significantly elevated hemoglobin a1c.¿ the (b)(6) 2013 discharge summary states: ¿during a period of about 3 months, the patient was started on a strict diet as well as also exercise, walking which was able to improve his hemoglobin a1c to about 9.The blood pressure also improved.Prior to this admission the patient was explained that this surgery that would be a surgery of high risk because of the size of the hernia plus also because of the pre comorbid conditions including hypertension, diabetes, and especially morbid obesity.The patient was explained that dur5ing the repair the patient will undergo a repair with a large mesh to reinforce most of the anterior wall.The patient also has varicose veins, which also with other conditions put him at high risk for a dvt and also pulmonary embolism.Having all that explained to the patient, he agrees and he understands he is at risk which is a complication that include hematoma because of the blood thinners, infections because of the extensive surgery and place a mesh, plus also diabetes, complications like dvt, pulmonary embolism, heart attack, and even death.¿ ¿the patient shows to be a large patient, he is about 6 feet 3 inches in height but he weighed almost 400 pounds.¿ the (b)(6) 2013 discharge summary continues regarding additional details on the (b)(6) 2013 procedure: ¿the patient as per preop diagnosis found he has a large ventral hernia.Plus also we explored the umbilical hernia.During the dissection we ran into some suture material and also we ran into the mesh that was used for the prior repair.Once it was completed and exposed, we proceeded to open the midline fascia and explored the area in the lower part of the incision near the umbilicus.¿ ¿carefully we dissected that area and separated the omentum and the bowel from the sac and from the fascia.When this was complete, then we proceeded to approximate the edges of the rectus muscles without significant tension using #1 prolene interrupted.This allowed us to approximate the rectus muscles to the midline.Also, primary approximation was done at the defect of the umbilical area using the mesh that was already placed on the patient from the previous surgery.¿ ¿¿we placed a mesh and closed the incision.¿ history and physical records dated (b)(6) 2013 state: ¿this is a patient who was directly admitted with a complication of abdominal wall abscess.The patient had surgery on (b)(6) 2013.Patient stayed in the hospital for about 4 days until he was discharged, stable, eating well, without fever, ambulating.The patient during the immediate postop was seen in my office 3 times on the third time the patient was not feeling well.He was felling kind of lethargic.He said he had chills.No fevers were detected.He had no nausea, no vomiting, no diarrhea, no abdominal pain.The patient, because of the symptoms because he had some shortness of breath, was transferred to the emergency room.¿ ¿the pain [sic] underwent extensive evaluation including ct scan of the chest, ct scan of the abdomen, blood tests, also [he] was evaluated for possible dvt as well as also pulmonary embolism.Except very mild leukocytosis of about 10,500, the patient did not have any other abnormality.The patient was sent home¿¿ the (b)(6) 2013 records state: ¿that afternoon after being discharged the wife found the patient was very sleepy, was hard to be aroused, and also he felt light-headed.Because of those complaints, he was admitted, transferred via paramedics to the emergency room again.On (b)(6) 2013 and admission to the hospital and immediately a ct scan of head was done, which showed no abnormalities.There was no evidence of stroke or any type of intracranial pathology.Again, bloodwork was repeated on that day [illegible] and again revealed mild leukocyte esterase and no other abnormality.Anyway, because of these symptom, the patient was admitted and iv antibiotic.At the time of admission, the patient was alert, oriented x3, no headache, no blurred vision.¿ ¿the patient has several comorbid conditions which includes morbid obesity, diabetes mellitus type 2, plus also hypertension and also dyslipidemia.¿ the (b)(6) 2013 records continue: ¿abdomen: globulous type.There is a surgical scar.There is some mild [illegible] dullness in the front of the abdomen.There are no acute changes.There is minimal pain.There is also an opening on the right lower quadrant, which represents the exit of a previously jackson-pratt.There is no discharge.¿ ¿diagnoses: abdominal wall abscess, cellulitis, rule out sepsis below the mesh, status post large ventral incisional hernia repair on 09/26 with a large gore-tex mesh placed into the anterior wall of the¿abdomen.¿ consultation records dated (b)(6) 2013 state: ¿ct scan of the abdomen showed a fluid collection in the abdominal wall above the mesh and is recommended to have surgical i and d of the abdominal wound.He was transferred here for surgical exploration and continuation of treatment.The patient also had fever and chills in the past few days.The culture of the abdominal wall wound on october 9 shows mrsa and the blood culture on october 8 showed no growth.¿ consultation records dated (b)(6) 2013 state: ¿this is a 52-year-old, obese, white male, who is well-known to me from previous evaluations following a large ventral hernia repair on (b)(6) 2013 , which was complicated my postop atelectasis and pneumonia.The patient required aggressive respiratory therapy and antibiotic and was able to go home in good condition.¿ operative records dated (b)(6) 2013 state the patient underwent ¿exploration of the abdominal wall, drainage of a large collection of serosanguineous fluid, cloudy, about 2500 cc.Removal of gore-tex graft and also closure of the main incision of the abdominal with #1 prolene.¿ postoperative diagnoses are noted as sepsis, large abdominal wall abscess status post large ventral hernia repair, morbid obesity, hypertension, diabetes mellitus type 2, hyperlipidemia, and bilateral varicose veins.Findings state: ¿a large collection of serosanguineous, cloudy fluid, gore-tex graft, had collection behind the graft, between the abdominal wall and the graft.¿ the (b)(6) 2013 operative report states: ¿cultures were taken from the opening of the previous drainage that was in the right upper quadrant, and for aerobic and anaerobic.This was followed by removal of the staples and carefully we opened an area of the incision.We [illegible] suction.A total of 2500 cc of serosanguineous cloudy fluid was obtained.This also was sampled for aerobic and anaerobic.Once all the fluid was removed, we proceeded to open the abdominal wall.The abdominal wall showed a thick exudate covering the abdominal wall on the subcutaneous side and also on the fascial side.The gore-tex was opened and once it was opened it was found also to have some fluid collection behind the gore-tex.¿ the (b)(6) 2013 operative report continues: ¿at this point, because of this collection, we proceeded to remove the gore-tex, profusely completely irrigate and lavage this area.Profuse irrigation with several liters of saline was used to irrigate and also soft debridement surface of the fascia and also subcutaneous, we used with soft debridement with [illegible].The main incision was reinforced with multiple sutures of 1-0 prolene interrupted from the top to the bottom of the incision.Once it was completed, we proceeded to irrigate, and irrigation again was followed by placement of retention type of sutures to the skin and subcutaneous, in order to approximate the skin.Also 4 jackson-pratt drains were placed in each side, 2 on each side of the abdominal wall.They were exteriorized through independent new openings, and they were anchored with 2-0 silk.¿ it is unclear from the records if both the gore device and the previously placed non-gore device were removed during the procedure.Surgical pathology report dated (b)(6) 2013 regarding a specimen collected (b)(6) 2013 states: ¿clinical history: exploratory laparotomy, exploration of abdominal wall with debridement and placement of multiple drains.Preoperative diagnosis: abdominal wall abscess.Specimen submitted: graft from abdominal cavity.Gross description: received in formalin labeled with patient¿s name and ¿graft from abdominal cavity¿ is a roughly rectangular portion of yellowish foreign body graft material, measuring 35.0 x 15.0 cm in diameter and 0.1 cm in thickness.¿ ¿gross diagnosis: graft from abdominal cavity.¿ wound culture report dated (b)(6) 2013 regarding a specimen collected (b)(6) 2013 states: ¿gram stain (final): 10-25 rbc¿s / lpf.Occasional (less than 1) wbc / lpf.No organisms seen.¿ ¿isolate 1 (final): scant growth staph aureus ¿ methicillin resistant.¿ anaerobic culture report dated (b)(6) 2013 regarding specimen collected (b)(6) 2013 states: ¿no anaerobic growth after 4 days.¿ wound culture report dated (b)(6) 2013 regarding a specimen collected (b)(6) 2013 states: ¿gram stain (final): occasional (less than 1) pmn / lpf.Occasional (less than 1) squamous epitheilial cells / lpf.Few gram positive cocci.¿ ¿isolate 1 (final): moderate growth staph aureus ¿ methicillin resistant.¿ history and physical records dated (b)(6) 2013 state the patient was seen for ¿1.Wound with cellulitis/abscess abdominal wall.2.Diabetes.3.Anemia.¿ ¿the patient has had ventral hernia, and received surgical intervention with placement of mesh on (b)(6) 2013.Unfortunately, after the surgery, the patient developed infection of the wound on the abdominal wall.On (b)(6) 2013 he received another surgery with drainage of the abscess on the abdominal wall and removal of the mesh.The patient was found to have mrsa infection of the abdominal wall.He was also found to have mrsa colonization of the nares.The patient was treated with antibiotics.¿ ¿his abdominal wound had been getting better gradually with improvement of the edema and erythema and decrease of amount of fluid from the jp drainage.The jp drainage was removed on (b)(6) 2013.The (b)(6) 2013 records state: ¿blood culture on (b)(6) showed no growth.Stool c difficile on october 24 shows negative.Urine culture october 25 showed no growth, and culture of the wound abdominal wall on (b)(6) shows mrsa.¿ urine culture results dated (b)(6) 2013 regarding a specimen collected (b)(6) 2013 states: ¿10,000-50,000 candida albicans.¿ ¿<10,000 lactobacillus species.¿ wound culture results dated (b)(6) 2013 regarding a specimen collected (b)(6) 2013 states: ¿gram stain (final): no wbc¿s seen.No organisms seen.Isolate 1 (final): staph aureus ¿ methicillin resistant.¿ history and physical records dated (b)(6) 2013 state the patient ¿¿has been admitted through the emergency room because of a complaint of abdominal pain, and also redness and a sensation of fluctuating mass on the upper portion of the abdomen.[the patient] is a patient well-known to us.He came for the first time (b)(6), when he underwent an operation for a large ventral and umbilical hernia.His comorbid conditions at that time were hypertension, also morbid obesity, plus diabetes type 2, and also extensive varicose veins.The patient, prior to that operation, he underwent extensive preop evaluation including cardiovascular, respiratory, and he was finally cleared for the surgery.The first surgery he underwent was a large repair with also reinforced with a large mesh.¿ the (b)(6) 2013 records state: ¿the patient stayed in the hospital for 7 days and eventually went home, to return in about 10-12 days postop.Readmitted because of abdominal pain, enlargement and fever and the patient has elevated white count, and a ct scan that was done¿.Shows that the patient has a large collection in the subcutaneous area in front of the mesh and the patient was brought and admitted on emergency basis, underwent surgery the same day, and large opsite was evacuated.The patient was proved to have mrsa that grew from the wound especially for outside the wound.This mrsa was not cultured initially on the inside of the wound.The patient was explored, the wound was left open and treated with antibiotics.The patient has had a prolonged and extensive care of the wound.¿ ¿the patient was discharged not before the culture was negative, [he] was stable and the wound was completely entirely closed.At that moment, the patient was sent home to complete an oral course of antibiotics.¿ the (b)(6) 2013 records continue: ¿at the end, the patient was doing well, but about 3 days ago, the patient noticed that there was like a pain on the upper portion of the abdomen.On his own, he started taking cipro from a previous prescription that was given to him without consulting with me or with any other physician, but any way, the patient felt a little bit better.The patient was seen in the office yesterday¿and the patient after they examined the abdomen and being suspicious and diagnosis that the patient probably has an infection and probably an abscess, we referred the patient to the emergency room where [he] underwent multiple evaluations including a ct scan and the ct scan shows that there is an abscess collection in the subcutaneous area.The patient was decided to be admitted and started with orders and prepare the patient for surgery on the following morning.¿ the (b)(6) 2013 records state: ¿abdomen: the abdomen is red, distended and on the upper portion of the abdomen.The wound also in the upper portion about 10 cm is fluctuant.Deep palpation is negative.¿ ¿diagnoses: 1.Morbid obesity, abdominal wall abscess status post complex repair of the large ventral umbilical hernia, plus also status post drainage of a large abscess with delayed closure of the abdomen, with delayed closure of the incision.2.History of methicillin-resistant staphylococcus aureus infections and treated extensively with antibiotics.3.Varicose veins.¿ ct scan records dated (b)(6) 2013 state: ¿there is a fluid collection within the anterior subcutaneous fat of the upper abdomen measuring 12 x 3 x 6 cm.There is an additional fluid collection containing multiple foci of gas within the anterior subcutaneous fat anterior to the surgical mesh material in the region of the umbilicus measuring approximately 7 x 6 x 4 cm.Associated mild mesenteric fat stranding is noted within the anterior abdominal subcutaneous fat.These findings may represent postoperative seroma or hematoma; however, the possibility that these collections are infected cannot be excluded.No intraabdominal fluid collection is identified.¿ consultation records dated (b)(6) 2013 state: ¿this 52 years old male patient was admitted from the nursing on (b)(6) 2013 , because of abdominal pain, and edema and erythema in the abdominal wall for 4 days.¿ ¿the patient was given iv vancomycin since admission.Today, he underwent i and d of the abdominal wall abscess.He was found to have about 300 ml of bloody turbid fluid in the abdominal wall.Two drainage tubes were placed.The patient still complains of abdominal pain.¿ ¿he has had a ventral hernia, underwent surgical intervention with mesh placement on (b)(6) 2013.He was admitted¿.From (b)(6) 2013 to (b)(6) 2013 , because of abscess and cellulitis abdominal wall.He received surgical i and d.The culture shows mrsa.Patient was treated with iv vancomycin.From (b)(6) 2013 to (b)(6) 2013 , the patient was treated at subacute unit with iv antibiotics and wound care.¿ the (b)(6) 2013 records state: ¿abdomen: soft and obese.There is a surgical wound on the abdomen with a clean dressing.There are 2 drainage tubes with serosanguineous fluid.The bowel sounds are audible.There is tenderness surrounding abdominal wall wound.¿ ¿impression: 1.Abscess with cellulitis of abdominal wall, status post surgical incision and drainage.¿ operative records dated (b)(6) 2013 state the patient underwent exploration of the abdomen, debridement, and drainage of a large abscess.Postoperative diagnosis: ¿large abdominal wall abscess, status post hernia repair, status post infection of the abdominal wound, methicillin-resistant staphylococcus aureus.¿ the (b)(6) 2013 operative report states: ¿the abdomen was opened using the same incision since it was fluctuant in the upper portion.We made an incision about 6 inches long from the xiphoid down to the mid portion between the xiphoid and umbilicus.Upon entering the abdominal wall, we encountered a large hematoma and also there is turbid and cloudy pus liquid.The patient presented with 2 large abdominal wall abscesses; one is about 10 inches in diameter and the other, on the opposite side of the abdomen, is about 5 inches in diameter.Both abscesses were communicating to the midline.We collected a total of about 300 ml of bloody pus.This was sampled and sent for aerobic, anaerobic and culture.This was followed by profuse irrigation of the abdominal wall with at least 5 l of bacitracin solution.Once it was completed, we proceeded to place 2 drains; a jackson-pratt on the inside of the abdomen that will help the patient when he is laying down on his back.The wound was not closed, it was left open.Hemostasis was checked and was followed by packing with iodoform.The wound was covered with medicated dressing and then an abdominal binder was fit to the patient.¿ wound culture results dated (b)(6) 2013 regarding abdominal wall abscess specimens collected (b)(6) 2013 states: ¿gram stain (final): no wbc¿s seen.Occasional gram positive cocci.¿ ¿isolate 1 (final): scant growth staph aureus ¿ methicillin resistant.¿ anaerobic culture results dated (b)(6) 2013 regarding an abdominal wall abscess specimen collected (b)(6) 2013 states: ¿no anaerobic growth after 4 days.¿ blood culture results dated (b)(6) 2013 regarding specimen collected (b)(6) 2013 states: ¿no growth after 5 days.¿ discharge summary records dated(b)(6) 2014 state the patient ¿¿with morbid obesity, diabetes mellitus, recurrent abdominal wall abscess, status post complex repair of a large ventral umbilical hernia, also status post a large abscess of the abdomen with removal of the mesh, and delayed closure.He developed methicillin-resistant staphylococcus aureus infections.Also the patient has risk factors including varicose veins in both legs, severe, plus also morbid obesity, and also diabetes mellitus.The patient was admitted on emergency basis on (b)(6) 2013 via the emergency room.¿ ¿the patient had been treated when in the hospital and also ambulatory for an abscess that developed within the abdominal wall, and also that contaminated the mesh.¿ the(b)(6) 2014 discharge summary continues: ¿the patient prior to the admission to the hospital had recently complained that there was puffiness and tenderness at the level of the upper portion of the wound.The patient was starting to feel some fever and also felt some pain upper abdomen.He was recommended to go to the emergency room¿.Where, among others, the examination included ct scan of the abdomen that showed fluid collection into the upper part of the abdomen.The patient, once we had diagnosis, the patient was admitted to the hospital for operation and he will be taken to the or for debridement of the abdominal wall.The patient underwent the procedure well under general anesthesia.We explored the abdomen.We found a large cavity with serosanguineous and thick fluid.No frank pus was found.Multiple samples of the specimen were taken.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute 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.Continued on attachment - attachment: [section h.10.11 continuation.Pdf].
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Manufacturer Narrative
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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.H6: additional patient code: f1903.Previous patient codes (2091, 1690, 1994) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span (b)(6) 2013 through (b)(6) 2014 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Patient information: medical history: morbid obesity, diabetes mellitus, hypertension, anemia, , hyperlipidemia.Prior surgical procedures: appendectomy [unknown date] ¿umbilical hernia repair that was repaired and dehisced¿ ¿previous placement of a type of bard or marlex mesh¿ implant preoperative complaints: (b)(6) 2013: preoperative diagnosis: : ¿morbid obesity, diabetes mellitus, hypertension, varicose veins, large ventral hernia, and also umbilical hernia.¿ implant procedure: exploratory laparotomy with lysis of multiple adhesions to the abdominal wall, followed by repair of a large ventral and also recurrent umbilical hernia, large and also reinforcement repair with a large mesh of gore-tex.Implant: gore® dualmesh® biomaterial (11147519/1dlmc08) 26 x 34 cm, oval.Implant date: (b)(6) 2013 description of hernia being treated: ¿we made an incision from the xiphoid around and just below the umbilicus through the midline.Carefully we started the dissection of the subcutaneous tissue.Keeping in mind that because of the lovenox the patient will tend to bleed, for that reason the hemostasis was very critical as we progressed in the dissection.The subcutaneous was completely open and then we reached the midline and we were able to open the midline of the abdomen at the linea alba.As we dissected we found that there was a large ventral hernia with also separation of the rectus muscles, plus also there was a hernia around the umbilicus on the right side of the umbilicus and these.In this area we found there was significant scar because of the previous placement of a type of bard or marlex mesh.The division was done, we opened the sac and we proceed to enter the abdominal cavity.We entered the abdominal cavity, we made sure there was no incarceration of omentum or bowel.The bowel was not involved, but there definitely was involvement attachment of the omentum to the umbilicus as well as also to the omentum and bowel that were divided.These adhesions were divided and tied with ligature of 3-0 vicryl to avoid postop bleeding.Once this was completed we were able to clean and release all the adhesions attached to the anterior abdominal wall.We were able to then developed [sic] a flap from the base of the wound laterally and superiorly-inferiorly.This was done in order to create a space for placement of the mesh.On each side of the wound the subcutaneous was detached from the mass from the abdominal wall fascia, at least 4-5 inches on each side.Similarly this was done on the top and the bottom of the incision, but after doing that completing and making sure that the hemostasis was satisfactory we proceeded to irrigate the abdomen, review the bowel, review also the incision.At that point, we proceeded to close the main incision using #1 vicryl running, but interrupted every 3 inches.Multiple sutures were placed and eventually the cavity was closed.¿ implant size and fixation: ¿once the cavity once the main incision [sic] was closed then we proceeded to review the hemostasis of the subcutaneous aspect followed by tailoring of the mesh to the shape of the wound.The mesh was tailored into the space.Once the mesh was trimmed and tailored we proceeded to anchor the mesh using also a #1 gore-tex suture.Again, this was placed running, but interrupted in several areas.For this purpose we used mesh coverage.The mesh was completely attached to the fascia of the abdominal wall, this was followed by profuse irrigation, review hemostasis.Once it was completed we placed 2 jackson-pratt drains inside the incision and exteriorized from independent incision.The abdominal was closed by using 3-0 vicryl to the subcutaneous and then we proceeded to close the skin using multiple skin staples.¿ post-operative period: [3 days] (b)(6) 2013: discharge summary: ¿the patient is a 52-year-old male who was admitted with a long history of about an 8 month history of abdominal pain, distention as well as also pain on lifting and straining.The patient had previous surgery for an umbilical hernia that was repaired and dehisced.Also, the patient has a large ventral hernia.The patient suffers from morbid obesity, and for that reason he underwent an extensive preop evaluation which includes cardiac and also respiratory evaluation and clearance.The patient had a pulmonary function test.Also, the patient had an echo stress.Also, initially the patient has a significantly elevated hemoglobin a1c.¿during a period of about 3 months, the patient was started on a strict diet as well as also exercise, walking which was able to improve his hemoglobin a1c to about 9.The blood pressure also improved.Prior to this admission the patient was explained that this surgery that would be a surgery of high risk because of the size of the hernia plus also because of the pre comorbid conditions including hypertension, diabetes, and especially morbid obesity.The patient was explained that during the repair the patient will undergo a repair with a large mesh to reinforce most of the anterior wall.The patient also has varicose veins, which also with other conditions put him at high risk for a dvt and also pulmonary embolism.Having all that explained to the patient, he agrees and he understands he is at risk which is a complication that include hematoma because of the blood thinners, infections because of the extensive surgery and place a mesh, plus also diabetes, complications like dvt, pulmonary embolism, heart attack, and even death.¿ ¿the patient shows to be a large patient, he is about 6 feet 3 inches in height but he weighed almost 400 pounds.¿ ¿the patient as per preop diagnosis found he has a large ventral hernia.Plus also we explored the umbilical hernia.During the dissection we ran into some suture material and also we ran into the mesh that was used for the prior repair.Once it was completed and exposed, we proceeded to open the midline fascia and explored the area in the lower part of the incision near the umbilicus.¿ ¿carefully we dissected that area and separated the omentum and the bowel from the sac and from the fascia.When this was complete, then we proceeded to approximate the edges of the rectus muscles without significant tension using #1 prolene interrupted.This allowed us to approximate the rectus muscles to the midline.Also, primary approximation was done at the defect of the umbilical area using the mesh that was already placed on the patient from the previous surgery.¿ ¿¿we placed a mesh and closed the incision.¿ explant preoperative complaints: (b)(6) 2013: ¿this is a patient who was directly admitted with a complication of abdominal wall abscess.The patient had surgery on (b)(6) 2013.Patient stayed in the hospital for about 4 days until he was discharged, stable, eating well, without fever, ambulating.The patient during the immediate postop was seen in my office 3 times on the third time the patient was not feeling well.He was felling [sic] kind of lethargic.He said he had chills.No fevers were detected.He had no nausea, no vomiting, no diarrhea, no abdominal pain.The patient, because of the symptoms because he had some shortness of breath, was transferred to the emergency room¿¿ ¿the pain [sic] underwent extensive evaluation including ct scan of the chest, ct scan of the abdomen, blood tests, also [he] was evaluated for possible dvt as well as also pulmonary embolism.Except very mild leukocytosis of about 10,500, the patient did not have any other abnormality.The patient was sent home¿¿ ¿that afternoon after being discharged the wife found the patient was very sleepy, was hard to be aroused, and also he felt light-headed.Because of those complaints, he was admitted, transferred via paramedics to the emergency room again¿on (b)(6) 2013 and admission to the hospital and immediately a ct scan of head was done, which showed no abnormalities.There was no evidence of stroke or any type of intracranial pathology.Again, bloodwork was repeated on that day [illegible] and again revealed mild leukocyte esterase and no other abnormality.Anyway, because of these symptom [sic], the patient was admitted and iv antibiotic.At the time of admission, the patient was alert, oriented x3, no headache, no blurred vision.¿ ¿the patient has several comorbid conditions which includes morbid obesity, diabetes mellitus type 2, plus also hypertension and also dyslipidemia.¿ ¿abdomen: globulous type.There is a surgical scar.There is some mild [illegible] dullness in the front of the abdomen.There are no acute changes.There is minimal pain.There is also an opening on the right lower quadrant, which represents the exit of a previously jackson-pratt.There is no discharge.¿ ¿diagnoses: abdominal wall abscess, cellulitis, rule out sepsis below the mesh, status post large ventral incisional hernia repair on (b)(6) with a large gore-tex mesh placed into the anterior wall of the¿abdomen.¿ (b)(6) 2013: ¿ct scan of the abdomen showed a fluid collection in the abdominal wall above the mesh and is recommended to have surgical i and d of the abdominal wound.He was transferred here for surgical exploration and continuation of treatment.The patient also had fever and chills in the past few days.The culture of the abdominal wall wound on october 9 shows mrsa and the blood culture on october 8 showed no growth.¿ (b)(6) 2013: ¿this is a 52-year-old, obese, white male, who is well-known to me from previous evaluations following a large ventral hernia repair on (b)(6) 2013, which was complicated my postop atelectasis and pneumonia.The patient required aggressive respiratory therapy and antibiotic and was able to go home in good condition.¿ explant procedure: exploration of the abdominal wall, drainage of a large collection of serosanguineous fluid, cloudy, about 2500 cc.Removal of ¿gore-tex¿ graft and also closure of the main incision of the abdominal with #1 prolene.Explant date: (b)(6) 2013 findings: ¿a large collection of serosanguineous, cloudy fluid, gore-tex graft, had collection behind the graft, between the abdominal wall and the graft.¿ ¿cultures were taken from the opening of the previous drainage that was in the right upper quadrant, and for aerobic and anaerobic.This was followed by removal of the staples and carefully we opened an area of the incision.We [illegible] suction.A total of 2500 cc of serosanguineous cloudy fluid was obtained.This also was sampled for aerobic and anaerobic.Once all the fluid was removed, we proceeded to open the abdominal wall.The abdominal wall showed a thick exudate covering the abdominal wall on the subcutaneous side and also on the fascial side.The gore-tex was opened and once it was opened it was found also to have some fluid collection behind the gore-tex.At this point, because of this collection, we proceeded to remove the gore-tex, profusely completely irrigate and lavage this area.Profuse irrigation with several liters of saline was used to irrigate and also soft debridement surface of the fascia and also subcutaneous, we used with soft debridement with [illegible].The main incision was reinforced with multiple sutures of 1-0 prolene interrupted from the top to the bottom of the incision.Once it was completed, we proceeded to irrigate, and irrigation again was followed by placement of retention type of sutures to the skin and subcutaneous, in order to approximate the skin.Also 4 jackson-pratt drains were placed in each side, 2 on each side of the abdominal wall.They were exteriorized through independent new openings, and they were anchored with 2-0 silk.¿ relevant medical information: (b)(6) 2013: pathology: ¿received in formalin labeled with patient¿s name and ¿graft from abdominal cavity¿ is a roughly rectangular portion of yellowish foreign body graft material, measuring 35.0 x 15.0 cm in diameter and 0.1 cm in thickness.¿ (b)(6) 2013: wound culture: ¿isolate 1 (final): scant growth staph aureus ¿ methicillin resistant.¿ (b)(6) 2013: anaerobic culture: ¿no anaerobic growth after 4 days.¿ conclusions: 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 gore® dualmesh® biomaterial instructions for use 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: ¿improper positioning of the smooth, non-textured surface adjacent to fascia or subcutaneous tissue will result in minimal tissue attachment.Persistent seroma may result.¿ 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 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Previous patient codes (2091, 1690, 1994) were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span september 26, 2013 through october 5, 2014 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Patient information: medical history: morbid obesity, diabetes mellitus, hypertension, anemia, hyperlipidemia.Prior surgical procedures: appendectomy [unknown date] ¿umbilical hernia repair that was repaired and dehisced¿ ¿previous placement of a type of bard or marlex mesh¿.Implant preoperative complaints: (b)(6) 2013: preoperative diagnosis: ¿morbid obesity, diabetes mellitus, hypertension, varicose veins, large ventral hernia, and also umbilical hernia.¿ implant procedure: exploratory laparotomy with lysis of multiple adhesions to the abdominal wall, followed by repair of a large ventral and also recurrent umbilical hernia, large and also reinforcement repair with a large mesh of gore-tex.Implant: gore® dualmesh® biomaterial (11147519/1dlmc08) 26 x 34 cm, oval.Implant date: (b)(6) 2013.Description of hernia being treated: ¿we made an incision from the xiphoid around and just below the umbilicus through the midline.Carefully we started the dissection of the subcutaneous tissue.Keeping in mind that because of the lovenox the patient will tend to bleed, for that reason the hemostasis was very critical as we progressed in the dissection.The subcutaneous was completely open and then we reached the midline and we were able to open the midline of the abdomen at the linea alba.As we dissected we found that there was a large ventral hernia with also separation of the rectus muscles, plus also there was a hernia around the umbilicus on the right side of the umbilicus and these.In this area we found there was significant scar because of the previous placement of a type of bard or marlex mesh.The division was done, we opened the sac and we proceed to enter the abdominal cavity.We entered the abdominal cavity, we made sure there was no incarceration of omentum or bowel.The bowel was not involved, but there definitely was involvement attachment of the omentum to the umbilicus as well as also to the omentum and bowel that were divided.These adhesions were divided and tied with ligature of 3-0 vicryl to avoid postop bleeding.Once this was completed we were able to clean and release all the adhesions attached to the anterior abdominal wall.We were able to then developed [sic] a flap from the base of the wound laterally and superiorly-inferiorly.This was done in order to create a space for placement of the mesh.On each side of the wound the subcutaneous was detached from the mass from the abdominal wall fascia, at least 4-5 inches on each side.Similarly this was done on the top and the bottom of the incision, but after doing that completing and making sure that the hemostasis was satisfactory we proceeded to irrigate the abdomen, review the bowel, review also the incision.At that point, we proceeded to close the main incision using #1 vicryl running, but interrupted every 3 inches.Multiple sutures were placed and eventually the cavity was closed.¿ implant size and fixation: ¿once the cavity once the main incision [sic] was closed then we proceeded to review the hemostasis of the subcutaneous aspect followed by tailoring of the mesh to the shape of the wound.The mesh was tailored into the space.Once the mesh was trimmed and tailored we proceeded to anchor the mesh using also a #1 gore-tex suture.Again, this was placed running, but interrupted in several areas.For this purpose we used mesh coverage.The mesh was completely attached to the fascia of the abdominal wall, this was followed by profuse irrigation, review hemostasis.Once it was completed we placed 2 jackson-pratt drains inside the incision and exteriorized from independent incision.The abdominal was closed by using 3-0 vicryl to the subcutaneous and then we proceeded to close the skin using multiple skin staples.¿ post-operative period: [3 days] (b)(6) 2013: discharge summary: ¿the patient is a 52-year-old male who was admitted with a long history of about an 8 month history of abdominal pain, distention as well as also pain on lifting and straining.The patient had previous surgery for an umbilical hernia that was repaired and dehisced.Also, the patient has a large ventral hernia.The patient suffers from morbid obesity, and for that reason he underwent an extensive preop evaluation which includes cardiac and also respiratory evaluation and clearance.The patient had a pulmonary function test.Also, the patient had an echo stress.Also, initially the patient has a significantly elevated hemoglobin a1c.¿during a period of about 3 months, the patient was started on a strict diet as well as also exercise, walking which was able to improve his hemoglobin a1c to about 9.The blood pressure also improved.Prior to this admission the patient was explained that this surgery that would be a surgery of high risk because of the size of the hernia plus also because of the pre comorbid conditions including hypertension, diabetes, and especially morbid obesity.The patient was explained that during the repair the patient will undergo a repair with a large mesh to reinforce most of the anterior wall.The patient also has varicose veins, which also with other conditions put him at high risk for a dvt and also pulmonary embolism.Having all that explained to the patient, he agrees and he understands he is at risk which is a complication that include hematoma because of the blood thinners, infections because of the extensive surgery and place a mesh, plus also diabetes, complications like dvt, pulmonary embolism, heart attack, and even death.¿ ¿the patient shows to be a large patient, he is about 6 feet 3 inches in height but he weighed almost 400 pounds.¿ ¿the patient as per preop diagnosis found he has a large ventral hernia.Plus also we explored the umbilical hernia.During the dissection we ran into some suture material and also we ran into the mesh that was used for the prior repair.Once it was completed and exposed, we proceeded to open the midline fascia and explored the area in the lower part of the incision near the umbilicus.¿ ¿carefully we dissected that area and separated the omentum and the bowel from the sac and from the fascia.When this was complete, then we proceeded to approximate the edges of the rectus muscles without significant tension using #1 prolene interrupted.This allowed us to approximate the rectus muscles to the midline.Also, primary approximation was done at the defect of the umbilical area using the mesh that was already placed on the patient from the previous surgery.¿ ¿¿we placed a mesh and closed the incision.¿ explant preoperative complaints: (b)(6) 2013: ¿this is a patient who was directly admitted with a complication of abdominal wall abscess.The patient had surgery on (b)(6) 2013.Patient stayed in the hospital for about 4 days until he was discharged, stable, eating well, without fever, ambulating.The patient during the immediate postop was seen in my office 3 times on the third time the patient was not feeling well.He was felling [sic] kind of lethargic.He said he had chills.No fevers were detected.He had no nausea, no vomiting, no diarrhea, no abdominal pain.The patient, because of the symptoms because he had some shortness of breath, was transferred to the emergency room¿¿ ¿the pain [sic] underwent extensive evaluation including ct scan of the chest, ct scan of the abdomen, blood tests, also [he] was evaluated for possible dvt as well as also pulmonary embolism.Except very mild leukocytosis of about 10,500, the patient did not have any other abnormality.The patient was sent home¿¿ ¿that afternoon after being discharged the wife found the patient was very sleepy, was hard to be aroused, and also he felt light-headed.Because of those complaints, he was admitted, transferred via paramedics to the emergency room again¿on (b)(6) 2013 and admission to the hospital and immediately a ct scan of head was done, which showed no abnormalities.There was no evidence of stroke or any type of intracranial pathology.Again, bloodwork was repeated on that day [illegible] and again revealed mild leukocyte esterase and no other abnormality.Anyway, because of these symptom [sic], the patient was admitted and iv antibiotic.At the time of admission, the patient was alert, oriented x3, no headache, no blurred vision.¿ ¿the patient has several comorbid conditions which includes morbid obesity, diabetes mellitus type 2, plus also hypertension and also dyslipidemia.¿ ¿abdomen: globulous type.There is a surgical scar.There is some mild [illegible] dullness in the front of the abdomen.There are no acute changes.There is minimal pain.There is also an opening on the right lower quadrant, which represents the exit of a previously jackson-pratt.There is no discharge.¿ ¿diagnoses: abdominal wall abscess, cellulitis, rule out sepsis below the mesh, status post large ventral incisional hernia repair on (b)(6) with a large gore-tex mesh placed into the anterior wall of the¿abdomen.¿ (b)(6) 2013: ¿ct scan of the abdomen showed a fluid collection in the abdominal wall above the mesh and is recommended to have surgical i and d of the abdominal wound.He was transferred here for surgical exploration and continuation of treatment.The patient also had fever and chills in the past few days.The culture of the abdominal wall wound on october 9 shows mrsa and the blood culture on october 8 showed no growth.¿ (b)(6) 2013: ¿this is a 52-year-old, obese, white male, who is well-known to me from previous evaluations following a large ventral hernia repair on (b)(6) 2013, which was complicated my postop atelectasis and pneumonia.The patient required aggressive respiratory therapy and antibiotic and was able to go home in good condition.¿ explant procedure: exploration of the abdominal wall, drainage of a large collection of serosanguineous fluid, cloudy, about 2500 cc.Removal of ¿gore-tex¿ graft and also closure of the main incision of the abdominal with #1 prolene.Explant date: (b)(6), 2013 findings: ¿a large collection of serosanguineous, cloudy fluid, gore-tex graft, had collection behind the graft, between the abdominal wall and the graft.¿ ¿cultures were taken from the opening of the previous drainage that was in the right upper quadrant, and for aerobic and anaerobic.This was followed by removal of the staples and carefully we opened an area of the incision.We [illegible] suction.A total of 2500 cc of serosanguineous cloudy fluid was obtained.This also was sampled for aerobic and anaerobic.Once all the fluid was removed, we proceeded to open the abdominal wall.The abdominal wall showed a thick exudate covering the abdominal wall on the subcutaneous side and also on the fascial side.The gore-tex was opened and once it was opened it was found also to have some fluid collection behind the gore-tex.At this point, because of this collection, we proceeded to remove the gore-tex, profusely completely irrigate and lavage this area.Profuse irrigation with several liters of saline was used to irrigate and also soft debridement surface of the fascia and also subcutaneous, we used with soft debridement with [illegible].The main incision was reinforced with multiple sutures of 1-0 prolene interrupted from the top to the bottom of the incision.Once it was completed, we proceeded to irrigate, and irrigation again was followed by placement of retention type of sutures to the skin and subcutaneous, in order to approximate the skin.Also 4 jackson-pratt drains were placed in each side, 2 on each side of the abdominal wall.They were exteriorized through independent new openings, and they were anchored with 2-0 silk.¿ relevant medical information: (b)(6) 2013: pathology: ¿received in formalin labeled with patient¿s name and ¿graft from abdominal cavity¿ is a roughly rectangular portion of yellowish foreign body graft material, measuring 35.0 x 15.0 cm in diameter and 0.1 cm in thickness.¿ (b)(6) 20/13: wound culture: ¿isolate 1 (final): scant growth staph aureus ¿ methicillin resistant.¿ (b)(6) 2013: anaerobic culture: ¿no anaerobic growth after 4 days.¿ conclusions: 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 gore® dualmesh® biomaterial instructions for use 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: ¿improper positioning of the smooth, non-textured surface adjacent to fascia or subcutaneous tissue will result in minimal tissue attachment.Persistent seroma may result.¿ 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 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, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.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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Search Alerts/Recalls
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