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W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Device Problems
Off-Label Use (1494); Patient-Device Incompatibility (2682)
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| Patient Problem
Unspecified Vascular Problem (4441)
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| Event Date 11/04/2021 |
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Event Type
Injury
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Event Description
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The following literature publication was reviewed: palm, e., valtola, a., manninen, h.And saari, p., 2022.A modified candy-plug technique to occlude false lumen in aortic dissection.Cvir endovascular, 5(1), p.57.The article is a single case study of a 28-year-old male patient who presented with a type a dissection of the ascending aorta in september 2013 and who was treated with emergency repair using a bentall technique, replacing the hemiarch and proximal part of brachiocephalic trunk with tubular prostheses.The patient tolerated the procedure.Six days following the procedure, the patient presented with a dissection distal to the left subclavian artery (lsa) with a narrow true lumen.This dissection was resolved without a reintervention.In (b)(6) 2021, the patient was treated with aortic arch reconstruction using a thoraflex¿ hybrid device in a frozen elephant trunk technique.The mitral and tricuspid valve were also repaired.The lsa was untreated.Five days after the (b)(6) 2021 reintervention, ct imaging showed backflow into the false lumen.On the next day, the patient was treated with thoracic endovascular repair (tevar) using a gore® tag® conformable thoracic stent graft with active control system (ctag).Two pairs of intercostal arteries at the level and 15 mm proximal to the ostium of the truncus celiacus were left uncovered to reduce the risk of spinal ischemia.The patient tolerated the procedure.In (b)(6) 2021, ct imaging showed continued growth of the false lumen likely due to a tear at the level of the renal arteries.The proximal descending aorta increased to a maximum diameter of 60 mm.In (b)(6) 2021, the diameter had grown to 69 mm, and it was decided to treat the patient with a custom candy plug device.An additional ctag device was implanted above the original device with the distal end landing near the celiac trunk.A candy-plug device was created using a gore® excluder® aaa endoprosthesis and an amplatzer¿ vascular plug and implanted into the false lumen adjacent to the existing tevar.The patient tolerated the procedure.The above information was reported with gore reference (b)(4).Three days post-operatively, ct imaging showed that the candy-plug had expanded correctly but backflow into the false lumen was still observed (present event).The patient was treated with an additional coil embolization.One month later, backflow to the false lumen disappeared.The maximum aortic diameter reduced from 69 to 66 mm.
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Manufacturer Narrative
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It was reported "in (b)(6) 2021, the patient was treated with aortic arch reconstruction using a thoraflex¿ hybrid device in a frozen elephant trunk technique.The mitral and tricuspid valve were also repaired.The lsa was untreated.Five days after the (b)(6) 2021 reintervention, ct imaging showed backflow into the false lumen.On the next day, the patient was treated with thoracic endovascular repair (tevar) using a gore® tag® conformable thoracic stent graft with active control system (ctag)." therefore (b)(6) 2021 was used as the date of implantation as a best estimate.It was reported that "three days post-operatively, ct imaging showed that the candy-plug had expanded correctly but backflow into the false lumen was still observed." therefore (b)(6) 2021 was used as the onset date of the event as a best estimate.Within this literature two events have been reported.They are reported with gore reference numbers (b)(4) and (b)(4).The investigation is ongoing.Preliminary results or conclusions are not yet available.A request was emailed to the author to clarify device information and the cause of false lumen perfusion following the tevar procedure.Further more patients outcome and dicom imaging dataset have been asked to be shared with gore for evaluation.The answer is pending.H3-other: the device remains implanted in the patient.Therefore a device evaluation could not be performed.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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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Cause investigation and conclusion a request was emailed to the corresponding author to clarify device information and the cause of false lumen perfusion following the tevar procedure.Furthermore, patients outcome and dicom imaging dataset have been asked to be shared with gore for evaluation.The description was updated with additional information provided within the article and by the author.A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Based on the event description and the subsequent investigation we are unable to determine the cause of this incident and assign a root cause.However, the corresponding author responded to gore that "the most likely reason behind the rapid growth of the aneurysm was undoubtedly the large re-entries in the visceral segment of the descending aorta and the process itself had nothing to do with gore products per se.When we modified the excluder into the candy-plug, the continued contrast medium flow into the false lumen, however significantly reduced, was because of the gutters which remained between the candy-plug and the aortic wall which was the reason behind additional coiling.In follow-up, the aortic dimension reduced, and we do observe now a stable situation with the patient where the aneurysm has reduced a little furthermore in diameter." there is intentional off-label use reported in the literature indicating massive manipulation of the device before it was implanted: "we prepared the candy-plug (cp) device from tubular 36¿45 mm aortic extender endoprosthesis (gore excluder, w.L.Gore & associates, inc.Flagstaff, usa).A tight surgical knot with standard surgical knot technique using thick braided nylon suture to minimize the risk of knot tear (surgilon®, braided nylon) was made in-between the centermost stent struts (fig.1a).After that the tip of the delivery catheter was bent so that the wiring was visible and cut (fig.1b).Then the deployment wire was cut from the proximal end after opening the stent graft handle (fig.1c).The graft with the wire was removed from the device (fig.1d).The stent graft was then placed within the 18f sheath (dryseal, w.L.Gore & associates, inc.Flagstaff, usa) at the distal end.Both the 18f and 22f dilator tips were cut (fig.1e).The 18f dilator was placed back into the 18f sheath, in contact with the stent graft leaving the deployment wire outside the sheath (fig.1f).The 18f sheath, dilator and stent graft were then inserted as a package into the 22f sheath which is already positioned into the fl (fig.1g).The stent graft was pushed into the 22f sheath with the 18f dilator and sheath which were then removed and replaced by the 22f cut dilator.The cp was advanced under fluoroscopy control close to the tip of the 22f sheath and opened by pulling from the deployment wire (fig.2a and b).The cp was then advanced within the sheath into the proper place and opened by retracting the 22f sheath accordingly (figs.1h, 2c and d)." the instructions for use was reviewed and the following statements were identified: warnings and precautions: any modifications made to the device may cause serious surgical consequences or injury to the patient.Potential device or procedure-related adverse events adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak product section d1 was corrected based on additional information.
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Event Description
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The following literature publication was reviewed: palm, e., valtola, a., manninen, h.And saari, p., 2022.A modified candy-plug technique to occlude false lumen in aortic dissection.Cvir endovascular, 5(1), p.57.The article is a single case study of a 28-year-old male patient who presented with a type a dissection of the ascending aorta in september 2013 and who was treated with emergency repair using a bentall technique, replacing the hemiarch and proximal part of brachiocephalic trunk with tubular prostheses.The patient tolerated the procedure.Genetic testing revealed no other hereditary disorders than myh11 gene mutation (ehlers danlos syndrome).Six days following the procedure, the patient presented with a dissection distal to the left subclavian artery (lsa) with a narrow true lumen.This dissection was resolved without a reintervention.In december 2020, mra imaging showed a maximum proximal descending aortic diameter of 58 mm, indicating an increase of 2.5 mm per year since the original intervention.The true lumen diameter measured 9 mm and the false lumen measured 49 mm.The patient also presented with a grade iii/iv mitral valve regurgitation and the left ventricle of the heart had begun to dilate.In march 2021, the patient was treated with aortic arch reconstruction using a thoraflex¿ hybrid device in a frozen elephant trunk technique.The mitral and tricuspid valve were also repaired.The lsa was untreated.Five days after this surgery, cta imaging showed backflow into the false lumen.On the next day, the patient was treated with thoracic endovascular repair (tevar) using two gore® tag® conformable thoracic stent graft with active control system (ctag device, proximal 40¿40-200 mm, distal 37¿37-100 mm).Two pairs of intercostal arteries at the level and 15 mm proximal to the ostium of the truncus celiacus were left uncovered to reduce the risk of spinal ischemia.The patient tolerated the procedure.This event was reported with manufacturer report 2017233-2023-03896 in april 2021, cta imaging showed continued growth of the false lumen likely due to a tear at the level of the renal arteries.The proximal descending aorta increased to a maximum diameter of 60 mm.In november 2021, the diameter had grown to 69 mm, and it was decided to treat the patient with a custom candy plug device.An additional ctag device was placed as a continuation from the previous aortic stent graft and the distal end landed close to coeliac trunk.Then a candy-plug device was created using a gore® excluder® aaa endoprosthesis aortic extender endoprosthesis (pla device) and implanted.Along the waist of the candy-plug some coils (non-gore devices) were placed to enhance thrombosis of the false lumen and to resolve the gutter endoleaks around the candy-plug.The patient tolerated the procedure.Three days post-operatively, cta imaging showed that the candy-plug had expanded correctly but backflow into the false lumen was still observed.The patient was treated with an additional coil embolization.One month later, backflow to the false lumen disappeared.The maximum aortic diameter reduced from 69 to 66 mm.In communications with the corresponding he reported the following to gore: "the most likely reason behind the rapid growth of the aneurysm was undoubtedly the large re-entries in the visceral segment of the descending aorta and the process itself had nothing to do with gore products per se.When we modified the excluder into the candy-plug, the continued contrast medium flow into the false lumen, however significantly reduced, was because of the gutters which remained between the candy-plug and the aortic wall which was the reason behind additional coiling.In follow-up, the aortic dimension reduced, and we do observe now a stable situation with the patient where the aneurysm has reduced a little furthermore in diameter.".
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