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| Device Problems
Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
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| Patient Problems
Dyspnea (1816); Pain (1994); Pleural Effusion (2010); Hernia (2240); Discomfort (2330)
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| Event Date 05/01/2017 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: operative records dated (b)(6) 2004 indicate a left anterior mediastinotomy (chamberlain procedure) was performed, in addition to repair of a left lung hernia through the chest using a gore dualmesh® biomaterial.Postoperative diagnoses are noted as history of tobacco use, positive family history of premature coronary artery disease, atypical chest pain, chronic obstructive pulmonary disease, hemoptysis, hemochromatosis, positive tuberculosis skin test, and left hilar lymphadenopathy.The (b)(6) 2004 records state the patient ¿¿has multiple problems as listed above.It was noted on her ct scan that she has a markedly enlarged left hilar and mediastinal lymph nodes.These are not easily accessible except through a direct approach, and i was asked to do a chamberlain procedure.¿ findings from the (b)(6) 2004 procedure state: ¿after the chamberlain procedure had been completed, i noted that there was a significant lung hernia through the chest wall, which required chest wall reconstruction using a gore-tex dual mesh prosthesis.The lymph node in the left hilar/mediastinal region was quite large and the pathologist reported benign reactive hyperplasia.At the end of the operation, the lung expanded well and no longer herniated through the defect.¿ the (b)(6) 2004 operative report states that after the chamberlain procedure was performed, ¿at this point, i noted that i did have a chest wall defect and a lung hernia.The only way this could be repaired was to reconstruct the chest wall using gore-tex dual mesh prosthesis.An appropriate size was fashioned and it was secured to the edge of the left sternum.This completely repaired the chest wall defect.A standard three-layer closure was now carried out.¿ product item and lot number of the gore dualmesh® biomaterial were not provided.Records between (b)(6) 2004 and (b)(6) 2018 were not provided.A handwritten physician note dated (b)(6) 2018 states: ¿pain [increased] since last time.¿ ¿mesh likely failed.¿ ¿operation #1) anchor to sternum + ribs.#2) lungs are not strong.#3) need single lung ventilation.Need lung transplant.¿ medical records dated (b)(6) 2018 state the patient ¿¿with history of anterior left lung herniation [status post] chamberlain procedure & hernia repair via chest wall reconstruction and dual mesh gore-tex ((b)(6) 2004) seen in follow up regarding residual pain and budging [sic] at repair site.Lung herniation originally thought to be secondary to markedly enlarged left hilar and mediastinal lad.Pathology from the mediastinal ln was noted as reactive hyperplasia ¿ no tumor or granuloma seen.¿ the (b)(6) 2018 records state the patient ¿¿has an extensive medical [history] which entails [pulmonary artery hypertension], [chronic obstructive pulmonary disease] 2/2 tobacco use, on 5 l supplemental o2 x 5 years, [hypertension], [congestive heart failure], pvc, atrial flutter [status post] afl ablation on (b)(6) 2015, hemochromatosis, positive ppd and left hilar [lymphadenopathy].¿ the (b)(6) 2018 records continue: ¿in summary, [patient] complained of discomfort around mesh perimeter in left chest wall x 1 year.This is exacerbated coughing [sic] which causes tearing sensation in the chest wall.She is a former heavy smoker, 30 pack year history, quit (b)(6) 2018, with ongoing heavy second hand exposure in household.¿ the (b)(6) 2018 records state: ¿since patient¿s last visit, she underwent pulmonary function study in (b)(6) showing fev1 44%, dlco 38%, we referred her for lung transplant evaluation.She states she was seen by transplant surgeon and told she was an appropriate candidate but that her medicare was not sufficient to cover cost of surgery.¿ ¿also states he told her she did not have evidence of [pulmonary artery hypertension] at last visit.States she has contacted mesh company regarding recurrent lung herniation.¿ the (b)(6) 2018 records also state: ¿the patient also states the baseline pain at the chest wall has increased to 4/10 at rest, described as ¿pulling¿ in nature, and that movements like twisting or coughing exacerbate the pain to 7/10 described as ¿sharp¿ pain.¿ ¿she reports ongoing neck and back pain which are chronic conditions¿¿ exam notes from the (b)(6) 2018 visit state: ¿lungs:_diffusely diminished breath sounds posteriorly, o2 nc in [sic], non-labored respiration, no crackles, wheeze or rhonci.Mild peripheral edema, non pitting.¿ assessment notes from the (b)(6) 2018 visit state the patient ¿¿underwent a chamberlain procedure for lymphadenopathy in 2004.The lymph nodes were all negative at that time but a segment of the rib was removed and patch with a gore-tex mesh.Patient has had increasing o2 requirements has had more forceful cough.This likely led to the mesh pulling through its anchoring points.She has felt some ripping along the edges of the bulge.I suspect [the] mesh no longer maintains chest wall integrity and that is why she has a bulge of lung through the previous chamberlain site.I reviewed the reports and personally reviewed the images of her ct scan that shows a bulge of lung and a lung herniation at the site of the chamberlain procedure.¿ plan notes from the (b)(6) 2018 visit state: ¿she is on 5 l of oxygen at this time and fixing this hernia would require sewing the mesh to the sternum and anterior ribs and single lung ventilation which she would have a hard time tolerating.I think her best course of action for the future is to undergo lung transplantation with a can fix [sic] this defect at the same time as a lung transplantation.¿ the (b)(6) 2018 records provide the following results from a ct dated (b)(6) 2017: ¿no axillary or prevascular adenopathy.Small cysts subcentimeter pretracheal lymph node.Stable moderately predominant right hilar lymph node compared to prior study on (b)(6) 2012.Dilatation of the right and left main pulmonary arteries (right measuring 3.3; left measuring 4.2 cm).Status post cholecystectomy.¿ it should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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A patient reported to gore that she had a gore® dualmesh® biomaterial implanted on (b)(6) 2004 to rebuild the chest wall after having a mediastinal mass removed.She stated that about a year ago she started noticing protrusion in the chest area when she coughed.The patient reportedly has copd.She reported she went to a thoracic surgeon due to the protrusion and pain and the surgeon reportedly told her "the mesh is coming off" and the lung is protruding through.The patient also reported "the mesh has failed and needs to be redone." ".I now need a lung transplant.I have had to deal with a lot of pain from this.".
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Manufacturer Narrative
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Other relevant history: added medical and surgical history.Corrected conclusion code.Added supplemental medical record information.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows; however, other than the 10/12/2017 note described below, there is no mention of the dualmesh device in these records: operative records dated on (b)(6) 2004, indicating a gore dualmesh® biomaterial was implanted were submitted on the initial medwatch.Product lot and item numbers have not been provided to gore.In addition, gore has not been provided with medical records for the first 10 years post-implantation.Medical records dated on (b)(6) 2014, indicate the patient was seen for evaluation of pulmonary hypertension, copd, and chronic respiratory failure.¿51-year-old pleasant female who has a history of shortness of breath for last several years, diagnosed with copd, recently had more shortness of breath, underwent extensive workup in (b)(6) texas which included echocardiogram, bilateral heart catheterization, ct chest, sleep study and diagnosed with primary pulmonary hypertension, patient was started on letairis which she took for several months but since then moved to arizona, did not take her medications for last few months, worsening symptoms.Patient has been wheezing, increase her prednisone and now i been asked to evaluate the patient for further recommendation.Patient had been seen by dr.(b)(6), cardiology, echocardiogram is pending at this time.At this time i do not have no records [sic] from (b)(6), being requested at this time.Patient does complain of having the chest pain, no nausea vomiting diarrhea melena hematemesis abdominal pain urinary symptom, no headache or visual disturbance, occasional orthopnea but no pnd.Does complain of having increased weight due to chronic steroid use.No history of valley fever or tuberculosis.Also history of hemochromatosis requiring phlebotomy.Recent ct reviewed.¿ the records indicate the following assessments: pulmonary hypertension, copd, hypoxia, tobacco use, chronic pain syndrome, and obesity.Records for the ct referenced during the on (b)(6) 2014 visit were not provided.Medical records from september 2014 to march 2015 indicate the patient was seen for follow up regarding her copd, respiratory failure, and pulmonary arterial hypertension.The records include recommendations for the patient to cease smoking and decrease weight.Findings from a chest x-ray performed on (b)(6) 2015 state: ¿the lung fields are well-expanded.There is a mild prominence of the interstitium in a pattern similar to the last examination.There is a fullness in the hilar region on the left.This may be a prominence of the central pulmonary artery but a hilar mass is not excluded.There is a mild fullness in the right hilum as well.There areas are unchanged.The heart is not enlarged.There is no pleural effusion.A port-a-cath implant on the right remains with the catheter at the superior vena caval level.There are surgical changes in the left axilla.There is an electrode unchanged in position in the lower thoracic spinal canal.There are surgical changes in the cervical spinal column.¿ impressions from the x-ray state: ¿1.Masslike fullness in the central left hilum, unchanged.2.Mild prominence of interstitial markings persistent in both lung bases.3.No pleural effusion.¿ medical records dated on (b)(6) 2015, indicate the patient was seen for congestive heart failure.Surgical history is noted as cardiac catheterization in 2010, cardiac ablations in 2015 and 2017, partial hysterectomy, laparoscopic cholecystectomy, appendectomy, lumbar laminectomy, cervical laminectomy, left thoracotomy, chest wall reconstruction, tumor removal from thyroid, bladder surgery, and right salivary gland surgery.Medical records dated on (b)(6) 2017, indicate the patient was seen for follow up on chest pain.The records state: ¿55 year old patient with a history of pulmonary arterial hypertension, copd secondary to longstanding history of tobacco use (for which she is maintained on home o2 for sob at baseline), [hypertension], [congestive heart failure], [premature ventricular contractions], and atrial flutter [status post] typical [atrial flutter] ablation on (b)(6) 2015.Her sister has history of [arrhythmogenic right ventricular dysplasia] for which she underwent [transthoracic echocardiogram] on (b)(6)2015.Historically, she has preserved [left ventricular] function, normal valve function, and negative cardiac catheterization.Since her last visit one year ago, she reports palpitations and tachycardia with activity and intermittent chest pain and tightness.She states she is in the process of quitting cigarette use and is being worked up for a possible lung transplant.¿ medical records from july 2015 to february 2017 indicate the patient was seen for follow up on various conditions, including her copd, chronic respiratory failure, pulmonary arterial hypertension, chronic hypoxia, and bronchitis.Medical records dated on (b)(6) 2017, indicate the patient was seen for follow up for copd, pulmonary hypertension, chronic respiratory failure with hypoxia.¿symptoms resolved for 1 week, since returned.Still complaining of worsening shortness of breath despite being on 5l oxygen.Unable to walk short distances without oxygen saturation dropping into 80¿s.Long discussion with patient regarding increase activity, weight loss, diet to improve breathing.Counseled patient on need to quit smoking as it does not help lung disease.¿ medical records dated on (b)(6) 2017, indicate the patient was seen for follow up on severe copd and recurrent bronchitis and is ¿here today in the office because of cough and productive sputum.It is milky in color.She is also complaining of wheezing.She denies hemoptysis.She does have a history of pulmonary hypertension.Her symptoms were getting progressively worse.She had a chest x-ray which suggested no acute disease.She is on diuretics.She is on chronic oxygen.She does have ongoing nicotine use.¿ medical records dated on (b)(6) 2017, indicate the patient was seen for follow up on copd, pulmonary hypertension, and chronic respiratory failure with hypoxia.The records state: ¿still complaining of dyspnea on exertion despite being on 5l oxygen.Counseled patient on need to quit smoking as it does not help worsening lung disease.Long discussion regarding possible transplant candidate and need to stop smoking for 6 months prior to starting evaluation process.¿ medical records dated on (b)(6) 2017, indicate the patient was again seen for follow up on her chest pain.The records state: ¿since patient has symptomatic atrial fibrillation and has been refractory to anti-arrhythmic medication therapy, patient wants to proceed with radiofrequency ablation of atrial fibrillation.¿ medical records dated on (b)(6) 2017, indicate the patient was seen ¿for follow-up on copd, sleep apnea, pulmonary hypertension, chronic respiratory failure with hypoxia.Patient recently underwent ablation procedure.Denies any chest pain pleurisy or hemoptysis, no fever chills or night sweats.Patient still complained dyspnea on exertion, tired and fatigued.¿ ¿still continues to smoke only off for last 4 days.Explained to patient at length, with all the issues she has, also insurance issues etc.Would not be a good candidate for transplant.She also needs to quit smoking for 6 months before we can even proceed.¿ medical records dated on (b)(6) 2017, indicate the patient was seen for follow up on her copd, pulmonary hypertension, chronic respiratory failure with hypoxia.¿has been losing some weight, on my schedule she lost about 12 pounds in last 3 months and 21 pounds in last 6 months.Poor appetite, feels nauseated all the time.¿ records dated on (b)(6) 2017, indicate the patient was seen for atrial fibrillation.Discussion notes from the visit state: ¿patient also reports [history] mediastinal mass [status post] resection in 2004 with subsequent mesh insertion and feels increased prominence over the past year.I recommend she follow up with her ct surgeon for possible incisional hernia.¿ medical records dated on (b)(6) 2018 state: ¿here for follow-up on pulmonary hypertension, copd, chronic respiratory failure with hypoxia, doing remarkably well.Symptoms are under better control.Did quit smoking, now smokes electronic cigarettes.Denies any chest pain pleurisy or hemoptysis, no fever chills or night sweats, no orthopnea or pnd.¿ medical records dated on (b)(6) 2018 state: ¿here for follow-up on copd and chronic respiratory failure.55-year-old pleasant female with history of copd, chronic respiratory failure with hypoxia, chronic rhinitis, pah, was seen by dr.Kuo for left lung hernia evaluation.Felt that patient does not need any surgical intervention per send her for possible transplant evaluation.Extensive workup done, pft report reviewed.No reversibility.Echocardiogram shows normal ejection fraction with rvsp of 36 mmhg, in view of that unable to discontinue orenitram.We will reevaluate by echocardiogram in about 6 months.¿ ¿patient has lost significant weight, which is helping her breathing.No chest pain pleurisy or hemoptysis, no fever chills or night sweats, no cough or sputum production.¿ billing records dated on (b)(6) 2018 regarding the on (b)(6) 2018 indicate the following diagnoses: chronic obstructive pulmonary disease, chronic respiratory failure with hypoxia, tobacco use, chronic pain syndrome, chronic rhinitis, hypothyroidism, weight loss, and mild pulmonary hypertension.Prior billing records from 2014-2017 also indicate bronchitis and obesity.Records dated on (b)(6) 2018, indicate the patient had a ct of the chest performed for an indication of pain.The records state the following: ¿lungs and pleura: moderate pulmonary emphysema.There is evidence of left anterior pulmonary herniation measuring up to 2.6 cm, unchanged since prior study.Increased groundglass attenuation in bilateral upper lobes, similar to prior study which could be related to interstitial lung disease.There is a 7 mm pleural-based pulmonary nodule in the right upper lobe seen on series 3 image 60, unchanged since prior study.¿ impression from the ct states: ¿1.Stable 7 mm pleural-based pulmonary nodule in the right upper lobe.2.Evidence of left anterior pulmonary herniation, unchanged since prior study, likely postoperative.3.Moderate centrilobar and paraseptal emphysema.4.Evidence of pulmonary arterial hypertension.¿ the records indicate this study was compared to a previous study performed on (b)(6) 2013; however, the on (b)(6) 2013 study records were not provided.There is no mention of the gore device in the on (b)(6) 2018 records.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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B7: added surgical history.H6: conclusion code remains unchanged.H10/11: added supplemental medical record information.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records.There is no mention of the dualmesh device in these records.There is a (b)(6) 2018 note in which the patient describes a "biomesh" to her provider, but no further product specific information is provided.The additional details are as follows: records dated (b)(6) 2013 indicate a surgical history of appendectomy, gall bladder removal, knee surgery, laparoscopy, spinal fusion, thyroidectomy, and tonsillectomy.Records dated (b)(6) 2013 indicate the patient was seen by a pain specialist for evaluation and consultation of neck, low back pain, and chest wall pain.A new patient intake form completed by the patient for the visit states: ¿medial [illegible] mass removed in 04 rebuilt chest wall [left] side.Removed low [left] lobe lung, lymph nodes from [left] underarm removed, [left] side neck lymph nodes.Neck surgery, have had 3 different surgeries to remove tumors in chest.¿ the pain specialist¿s notes from the (b)(6) 2013 visit states: ¿she describes her pain as aching and burning with numbness, pins/needles into the hands and feet.She has a history of anterior cervical fusion and lumbar fusion.She has had multiple chest surgeries to remove a tumor of chest wall and multiple cysts.She has a history of partial left lobectomy.¿ diagnoses were noted as lumbar postlaminectomy syndrome, chronic pain syndrome, nerve root and plexus disorders, neuralgia, neuritis, and radiculitis.The records indicate the patient was prescribed with opioids.Medical record dated (b)(6) 2014 indicates lab results identify temazepam and oxazepam as ¿inconsistent results ¿ analyte detected but no corresponding prescription reported¿.Medical records dated (b)(6) 2015 state: ¿the patient did follow up with a surgeon who will be explanting her spinal column stimulator, updating her imaging and most likely moving forward with surgical correction for her cervical spine.¿ medical records dated (b)(6) 2015 state: ¿she also let us know that she did have her spinal column stimulator removed.She does have some postoperative discomfort, but is doing well.She is pending an mri of the cervical spine with consideration towards surgical correction.¿ medical records dated (b)(6) 2015 state: ¿the patient feels that she is doing well status post cervical revision of her fusion.¿ records dated (b)(6) 2016 indicate the patient was seen by a pain specialist for follow up on her neck and low back pain.The records state; ¿she was diagnosed with pulmonary arterial hypertension and given 6 months to live per patient.She now states she will live up to 7 years.Chronic o2 use.She is being considered for a heart transplant.¿ records dated (b)(6) 2017 state ¿she is having chest surgery and we will increase her short-acting opiod.¿ records dated (b)(6) 2017 indicate the patient was seen for follow up by her pain specialist on chronic diffuse pain involving the neck, thoracic spine, low back as well as the hips, chest, and lower extremities.The records state: ¿patient has a history of lumbar postlaminectomy syndrome as well as multiple other severe medical comorbidities.Patient has a history of copd and is on supplemental oxygen, patient also has a history of pulmonary artery hypertension which has been refractory to management requiring patient to be placed on a lung transplant list.Patient states that at her last evaluation, she was informed by her pulmonologist that she was developing signs of worsening heart failure.Patient also informs me that she has been losing weight without explanation.She has discussed this with her primary care doctor as well as her pulmonologist, and they are looking into potential etiologies.¿ drug test lab results dated (b)(6) 2018 from the pain specialist¿s office indicate the patient tested positive for methamphetamines.Records dated (b)(6) 2018 indicate the patient was seen by her pain specialist for follow up for ongoing issues of neck, low back, and hip pain.¿the patient is here noting a continued and persistent increase in neck pain.She wishes to undergo updated investigatory studies to better delineate any soft tissue pathology that would account for this pain.She also feels that the biomesh in her anterior chest wall may have moved or possibly there is a problem with scar tissue growth.As a result we will proceed with ct investigatory studies with contrast of the chest.¿ it should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: conclusion code remains unchanged.H10/11: added additional medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: a postoperative ct scan dated (b)(6) 2004 states: ¿there is now pulmonary vascular congestion.A small left pleural effusion cannot be excluded.There has been replacement of a left thoracotomy tube.A tiny volume left apical pneumothorax is noted.The mediastinum is midline.Bilateral hilar prominence, left greater than right is redemonstrated.Impression: pulmonary vascular congestion and a small left pleural effusion.New left-sided chest tube with tiny left apical pneumothorax.¿ records dated (b)(6) 2004 indicate a chest x-ray was performed to ¿check tube.¿ findings from the x-ray state: ¿study of the chest, single view, dated 07/30/04 at 0929 hours is reviewed.Left-sided chest tube remains in place with basal atelectasis/infiltrate.Right lung is clear.No pneumothorax visualized.The cardiac silhouette size is unchanged.The patient has now been extubated.¿ ¿impression: 1.Patient extubated.2.Left chest tube remains in place.No pneumothorax visualized.¿ records dated (b)(6) 2004 state an x-ray was performed for left base consolidation.¿there is no significant pneumothorax identified by plain radiography.Again noted is the previously described prominent left lower lobe consolidation with most likely pleural fluid.There is the suggestion of some degree of vascular redistribution without diagnostic findings for pulmonary edema at this point.Interstitial markings toward the right base are slightly more prominent.¿ ct scan records dated (b)(6) 2004 state: ¿impression: 1.Moderate-sized, left pleural effusion surrounding considerable left lower lobe atelectasis.2.Mild, but fairly widespread pneumonia involving right mid and lower lung.There is also likely mild pneumonia at the anterior portion of the left base.3.Mild mediastinal adenopathy without any dominant central mass appreciated¿¿ records dated (b)(6) 2004 state a ct scan was performed for an effusion recheck.¿there is perhaps a slight decrease in the left pleural effusion.What appears to be pulmonary edema remains.The mediastinal and cardiac borders are unchanged.¿ records dated (b)(6) 2004 state a ct scan was performed for an indication of pneumonia and bronchitis.¿cardiac silhouette size remains generous.Clips are noted from prior surgery in the left mid lung.There is elevation of the left hemidiaphragm, with pleural effusion, consolidation at the left lung base, and interstitial prominence throughout.A mild component of interstitial edema is not excluded, and overall, aside from removal of the picc line, no interval change is seen from the previous examination.¿ records dated (b)(6) 2004 state a ct scan was performed for an indication of shortness of breath.¿view of the chest demonstrates elevation of the left hemidiaphragm.There does appear to be some associated compressive atelectasis and perhaps a small left pleural effusion.The rest of the lungs appear clear.The cardiac silhouette is in the upper limits of normal.Pulmonary vascularity is unremarkable.Cervical clips are noted in the left hilum.Impression: elevated left hemidiaphragm with probable compressive atelectasis and small effusion.¿ pertinent records between (b)(6) 2004 and (b)(6) 2007 were not provided.Records dated(b)(6) 2007 state a ct of the chest was performed for an indication of chest, abdominal, and pelvic pain.¿no axillary, hilar, mediastinal, or rectocrural enlarged adenopathy is identified.Subcentimeter nonenlarged lymph nodes are noted adjacent to the thoracic aortic arch.There are no acute infiltrates, consolidations, or pleural effusions.Mild emphysematous change is present.The bone windows demonstrate no acute abnormalities.Nonenlarged 9-mm lymph node is noted in the precarinal region seen¿no focal liver lesions are identified.There is minimal prominence of the left-sided intrahepatic biliary ducts.The patient is status post cholecystectomy.The pancreas, spleen, adrenal glands, and both kidneys are unremarkable.There is no lymphadenopathy or loculated fluid collection.Atherosclerotic calcification is present in the abdominal aorta which is normal in caliber.There is no evidence of bowel obstruction or free air.There is no lymphadenopathy or loculated fluid collection.Low attenuation material within the cervix/uterus is present, nonspecific but may represent fluid.Impression: no acute abnormalities are identified within the chest, abdomen, and pelvis.¿ records between (b)(6) 2007 and (b)(6) 2013 were not provided.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 includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated patient codes.H6: additional patient codes: 2011; 2012; 2020; 3191: no code available for "atelectasis" "bulge" and "lung herniation".H6: updated conclusion codes.H6: additional conclusion codes: 4311; 4315.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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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