| Catalog Number VBJR071002A |
| Device Problems
Complete Blockage (1094); Off-Label Use (1494)
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| Patient Problems
Ischemia (1942); Pain (1994); Skin Discoloration (2074); Cramp(s) (2193); Numbness (2415)
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| Event Date 07/24/2018 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).It should be noted that the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use provide the following intended use / indications: ¿the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 6.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 ¿ 12 mm.The gore® viabahn® endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (av) access grafts.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state: ¿w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral, iliac arteries or the venous anastomosis of the arteriovenous (av) access circuit.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use continue: ¿w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.No device migrations or fractures were detected in 25 devices placed across the antecubital fossa in the avr 06-01 clinical study and patency rates were comparable to those of the entire gore® viabahn® endoprosthesis cohort.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding procedure related complications: ¿as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and / or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and / or death.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding device related complications: ¿complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and / or rupture; false aneurysm; infection; inflammation; fever and / or pain in the absence of infection; deployment failure; migration; and device failure.¿.
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Event Description
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It was reported to gore that on (b)(6) 2018, a patient was treated for a left leg popliteal artery aneurysm using two gore® viabahn® endoprostheses with heparin bioactive surface.The patient reported his leg felt better for a period of time after the (b)(6) procedure, but his leg did not improve as he had hoped.It was reported the swelling in the patient¿s left leg did not decrease, and he experienced a fair amount of discomfort that varied day by day.The patient reported that on (b)(6) 2018, he presented to his local emergency room with leg discoloration, intense cramping, and pain in his left leg, and it was reportedly determined there was no circulation below the patient¿s left knee.It was further reported that imaging showed the two gore® viabahn® endoprostheses were occluded.According to the report, the hospital emergently transferred the patient via air evacuation to (b)(6), where the patient was admitted for treatment of the occlusion.It was reported to the patient that a radiologist attending to the patient during his (b)(6) 2018 visit stated his stents did not occlude all at once, and that the occlusion was a gradual process.It was reported that on (b)(6) 2018, the operating surgeon ¿cleaned out¿ the occluded stents, then relined the stents with additional devices.The patient reported he is currently on home health care and is feeling better, although he is still experiencing a fair amount of discomfort and pain due to swelling.The patient reported he is currently keeping his leg elevated and is not able to mobilize much.Additional details regarding the patient¿s clinical course were ascertained from the gore associate present at the implanting procedure and are as follows: it was reported the (b)(6) 2018 procedure for treatment of the left leg popliteal artery aneurysm was off-label usage of the gore® viabahn® endoprosthesis with heparin.It was reported there were no notable conditions in the patient¿s anatomy during the implant procedure.Additionally, it was reported the (b)(6) 2018 procedure was performed successfully, and final imaging showed the two gore® viabahn® devices were patent.According to the implanting physician, the patient presented to the emergency room on (b)(6) 2018, where imaging reportedly showed occlusion of the gore® viabahn® devices with no run off in the patient¿s feet.It was reported that at some point that night, the patient was transferred to (b)(6), where the patient was admitted.It was reported that as part of the patient¿s overnight stay, the patient was ¿lysed¿, whereby a sheath was advanced and a continuous drip was set up to break down clot in the graft and thin the patient¿s blood.According to the report, additional imaging was performed on (b)(6) 2018, which showed the patient¿s vessels were open with no evidence of occlusion.It was reported that on the same day, the operating surgeon elected to implant an additional stent graft (manufacturer unknown) at the junction of the two previously implanted gore® viabahn® devices as a precautionary measure.No further adverse events were reported.Medical records for the implant procedure, the patient¿s postoperative clinical course, and the reported additional procedures were requested but have not been provided.
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Manufacturer Narrative
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B7: added patient medical and surgical history.D11: added patient medications - acetaminophen, albuterol, azelastine, digoxin, simvastatin, verapamil, warfarin.G4: corrected date.H6: conclusion code remains unchanged.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: records dated 5/14/2018 state: ¿patient is in clinic for evaluation of popliteal artery aneurysms.Apparently the patient had acute right popliteal artery aneurysm thrombosis that necessitated a bypass from the sfa i artery to the below-knee popliteal artery segment.It appears that the patient had vein harvested from the left lower extremity.He also has a history of firm hypercoagulable state though he was not completely investigated for it in the past.He shouldn¿t also had [sic] a history of for [sic] deep venous thrombosis atrial fibrillation.He has a history of remote history [sic] of cervical spine fracture.He is in clinic for a second opinion regarding the management of popliteal artery aneurysm.Patient denies claudication.His activity is limited by the copd symptoms.His wife has other health issues and she requires support from him for her daily activities.The patient also has swelling involving the right mid thigh that is pulsatile.He denies rest pain he has no tissue loss in both lower extremities.¿ assessment/plan notes from the 5/14/2018 visit state: ¿overall the patient has bilateral popliteal artery aneurysms.On the left side based on the ct angio evaluation the popliteal aneurysm is approximately 3.9 cm and appears to be suitable for endovascular reconstruction.Similarly on the right side patient has a patent bypass graft however the patient has a more proximal aneurysmal degeneration of the femoral artery and will also require corrective procedures.I will proceed with treating the left side given the fact that he has a fairly large aneurysm and acute thrombosis would mean he would require an emergent procedure.Given the fact that he has significant the [sic] pulmonary issues as well as him having to support his wife for her daily activities endovascular therapy would be ideal in this situation given the early recovery.We also discussed about the potential for the stent thrombosis as well as the open bypass procedure and the overall recovery associated with a major extensive open reconstruction.¿ operative records dated 5/24/2018 indicate the patient underwent: ¿1.Left popliteal artery aneurysm repair using stent grafts with an endovascular approach, 9 mm x 15 cm, plus a 7 mm x 10 cm viabahn.2.Left common femoral artery endarterectomy patch angioplasty for delivery of endoprosthesis.3.Placement of closure device in the right groin.¿ the 5/24/2018 operative report states: ¿subsequently, we made the access into the right common femoral artery.Using ultrasound guidance, a 6-french introducer sheath was placed using an ultrasound guidance.The patient was heparinized.We placed a catheter in the distal abdominal aorta and performed an up-and-over maneuver.We were able to advance the wire, however, we had a significant resistance and difficulty to track a 4-french catheter over the aortic bifurcation.We used multiple combinations of wires to facilitate the easy traversal of the catheter as well as subsequently a sheath placement.Given the fact that we had difficulty to advance the catheter even beyond iliac bifurcation and into the femoral artery.We felt at this point in time that the patient would have significant difficulty with the endovascular approach through the retrograde approach and hence, we plan for an antegrade approach.We made an incision then in the left groin.The incision was carried down to divide the skin, subcutaneous tissue, deep fascia.Later, we controlled the common femoral artery, superficial and deep femoral artery.As noted, we had difficulty to even retract the catheter out of the aortic bifurcation, i was concerned about the potential for sharing the aortic bifurcation and hence, we removed the catheter through the left femoral artery through the surgical cutdown.The patient was adequately heparinized for the entirety of the procedure.Upon clamping the artery, we then proceeded to make an arteriotomy in the left common femoral artery, that was later converted to a vertical arteriotomy.The 5/24/2018 operative report continues: ¿the omniflush catheter was removed through the left groin as we had difficulty to retract the catheter over the aortic bifurcation from the right side.Once the catheters were completely retracted, the 6-french sheath was left inside the right femoral artery till the end of the procedure, and ultimately the sheath was removed and access site in the right groin was closed using a mynx closure device.Meanwhile, we turned our attention to repair the left popliteal artery aneurysm to the antegrade approach.There was extensive amount of calcification and heavily calcified plaque within the common femoral artery that necessitated an endarterectomy extending into the superficial femoral artery.The distal flaps were tacked using a 6-0 prolene suture.The artery was reconstructed with a bovine pericardial patch.Prior to the completion of the pericardial patch closure, we placed a 9-french introducer sheath into the left superficial femoral artery.Angiographic evaluation was performed.Subsequently, the distal tibial arteries were cannulated for wire placement.Angiographic evaluation demonstrated there were a diffusely diseased popliteal artery and distal superficial femoral artery.¿ the 5/24/2018 operative report states: ¿we used the 7 mmx 10 cm viabahn that was placed just behind the knee segment of the popliteal artery and later the telescope another 9 mm viabahn stent of 15 cm.The overlapping zone of approximately 3 to 4 cm.The stents were post dilated with a 7 mm balloon as well as a 9 mm balloon.Completion angiographic evaluation demonstrates a successful exclusion of the aneurysm.There was type 2 leak identified.However, there was no type i or type 3 leaks visualized from the popliteal artery aneurysm /stents.¿ ¿the patient was stable throughout the procedure.I spoke with patient's family at the completion of the procedure.He had a good doppler tone at the ankle.¿ the 5/24/2018 operative records confirm two gore® viabahn® endoprostheses with heparin bioactive surface were implanted from the left femoral to popliteal artery during the procedure.The records indicate the patient was discharged home on 5/25/2018.Records between 5/24/2018 and 7/24/2018 were not provided.Records dated 7/24/2018 state the patient presented to the emergency department.¿the patient presents with 80 year old male presents to the ed for sudden onset leg cramping in his left lower extremity onset 4 hours ago (~1300).His left leg is cooler and paler than the right.Motor function is intact, but patient is complaining of paresthesias distal to the knee.The leg is not swollen.He took norco without relief.Patient is on coumadin.He says his inr was between 2-3 last week.He denies pain anywhere else.Continues to smoke.¿ radiology results from the 7/24/2018 emergency room visit state: ¿reported at 07/24/18 18:06:00, lower extremity arterial physiologic report: the right lower extremity is normal per waveforms and abi indices.The left lower extremity has severe arterial occlusive disease with no flow detected in the pta and ata.The fem-pop waveform obtained is abnormal and is most likely collateral flow.The left fem-pop stent graft is possibly occluded.The left lower extremity great toe waveform is absent.¿ ¿notes: #acute leg ischemia due occluded popliteal stent.Pain meds prn, heparin bolus/gtt, transfer to methodist.¿ the 7/24/2018 records continue: ¿time: 07/24/18 17:37:00.Notes: ¿arterial doppler shows no flow from stent distally.Good triphasic waveform in common femoral artery.Distal femory artery occluded just before stent.No flow distal to stent.No posterior tibial or dorsalis pedis flow.Questionable popliteal collateral flow.Notes: [patient] having increased difficulty moving lle, was able to wiggle toes easily before now is difficult, still can plantar/dorsiflex but decreased compared to prior.¿ impression and plan notes from the 7/24/2018 er visit state: ¿left leg ischemia.Left popliteal artery stent occlusion.¿ the records indicate the patient was transferred by air evacuation to iu health methodist hospital.Results of a ct taken 7/24/2018 at iu health methodist state: ¿left: calcified and noncalcified plaques of the left common iliac, internal iliac and external iliac arteries.Calcified and noncalcified plaque involving the left common femoral artery and superficial femoral artery.Diminutive caliber and flow of the left deep femoral arteries.Just proximal to the level of the adductor hiatus at the proximal extent of the left sfa stent, there is abrupt cut off of opacification.At this level, there is a 3.0 x 2.7 cm aneurysm.Just distal to this, an irregularly-shaped lobular aneurysm involving the distal sfa just proximal to the popliteal artery, which measures approximately 3.8 x 3.3 cm, similar to slightly decreased in size compared to 4/26/2018.The entire extent of the left sfa and popliteal artery stent is thrombosed.The trifurcation, anterior tibial, posterior tibial and peroneal arteries are not opacified an demonstrate diffuse vascular calcifications.¿ ¿impression: 1.Unopacified/thrombosed left sfa/popliteal stent with lack of opacification of the left lower extremity distal runoff.2.Patent right sfa-popliteal artery bypass graft.Anterior tibialartery is unopacified, though the posterior tibial and peronealarteries are patent.There is reconstitution of dorsalis pedis at thelevel of the ankle joint.¿ operative records dated 7/24/2018 indicate the patient underwent left lower extremity arteriogram and initiation of catheter directed thrombolysis.Indications for the procedure state: ¿2 months status post elective repair of left popliteal artery aneurysm using overlapping 7 and 9 mm viabahn stentgrafts.Acute thrombosis of the stent grafts resulting in a cold leg.The left foot is insensate, although motor function is largely preserved and he is having calf pain.The lower leg and foot are cold and pale with no dopplerable signals.¿ findings from the 7/24/2018 procedure state: ¿there is complete occlusion of the left popliteal artery and all 3 runoff vessels down into the foot by acute thrombus.Despite large bolus arteriography and delayed imaging, there is no significant reconstitution of the runoff vessels identified.There is abrupt occlusion of the above-knee popliteal artery at the proximal margin of the stents.[there] is minimal reconstitution of peroneal and posterior tibial arteries which are seen to contain thrombus throughout.A glidewire was advanced into the stents.A 4 french berenstein catheter was advanced.The catheter was advanced over the wire into the posterior tibial artery.The catheter was exchanged over an amplatz wire for a 5 french, 50 cm infusion length with the sidehole infusion catheter.The catheter was positioned with the proximal sidehole beginning at the proximal extent of the thrombus extending into the mid posterior tibial artery.Tpa was initiated at a rate of 0.5 mg per hour.Heparin infusion is continued through the sidearm of the left arterial femoral sheath.¿ impression from the 7/24/2018 procedure states: ¿complete thrombotic occlusion from the proximal popliteal artery into the foot of all named arteries.Catheter directed thrombolysis was initiated, as described above.¿ records dated 7/24/2018 state: ¿80 yr old male [prior medical history of] copd, pad, htn, hld, and a-fib presented to methodist hospital from iu bloomington hospital with lle ischemia.Per report [patient] began to have pain/cramping in left foot around 1300, nothing he did would relieve the pain/cramps.He then attempted to help the pain by taking a couple of norco's.He reports that they did help take the edge off of the pain, however around 1400 he noticed that his left leg was a different color and temperature from the right.At 1500 he began to notice his foot was numb.At that time he went to iu bloomington where he received a cta that showed his left popliteal stent was thrombosed.He was transferred to iu methodist with vascular surgery for higher level of care.Upon arrival to ed [patient] was seen by vascular who also consulted ir, and felt the best option would be to attempt a thrombolysis.[patient] then went to ir and had lytic catheters placed.[patient] was tranferred to critical care and icu was asked to consult.¿ records dated 7/25/2018 state: ¿patient is [status post] lytic catheter placement through left femoral artery.He reports still having numbness and sharp, aching pain in left foot.Endorses medication adherence with is home warfarin (started for a-fib) and states that his inrs have always been therapeutic or higher.However on chart review inr was subtherapeutic on admission and was ~1 in 3/2018.Of note, patient does his own inr checks and follows with roache inr company.¿ exam notes state: ¿extremities: purplish discoloration of distal foot l>r, tenderness to palpation of l foot, pain with dorsiflexion and plantar flexion.No swelling of foot or calf; l foot warm, dp pulse palpable.¿ operative records dated 7/25/2018 indicate the patient underwent ¿left lower extremity arteriography for thrombolysis follow-up, mechanical thrombectomy and balloon angioplasty and repeat stenting of the left popliteal artery stent.¿ indication for the procedure states: ¿15 hours status post initiation of catheter directed thrombolysis for acute thrombosis of the left popliteal and tibial arteries 2 months status post elective endograft repair of left popliteal artery aneurysm.Overnight, the patient's foot has gone from cold and insensate to warm with normal sensation.Dopplerable signals have returned to the foot, as well.¿ findings from the 7/25/2018 procedure state: ¿contrast was injected through the antegrade left femoral sheath and an arteriogram was performed.This showed markedly improvement in perfusion compared to the arteriogram from last night.The left popliteal artery stent grafts are now largely patent.There is linear filling defect in the proximal-mid portion of the stents presumed to be residual thrombus.The below-knee popliteal stent portion is patent.The tibial peroneal trunk is patent.All 3 runoff vessels are patent into the foot.The pedal arteries are widely patent.Overall the degree of thrombolysis is remarkably successful.¿ the 7/25/2018 procedure findings continue: ¿in order to deal with the presumed residual thrombus within the stents, a 7 mm spider filter wire was positioned in the bottom of the stents.A 6 french angiojet catheter was introduced and mechanical thrombectomy of the proximal and midportion of the stents was performed.A post thrombectomy arterial gram was performed which showed no improvement, although the linear filling defect has changed configuration.8mm low pressure balloon angioplasty was then performed within the area of the stents with the filling defect.Another arteriogram shows decreased rate of flow through the stents.The filling defect now appears to be, not linear thrombus but rather actual dehiscent fabric from the covered stents in intraluminal location.This appears to be confined to the 9 mm more proximal stent and extends abruptly up to the margin of the 7 mm stent.There is also a small filling defect within the filter wire.¿ the 7/25/2018 procedure findings state: ¿an 8 x 150 mm viabahn was then deployed extending the proximal edge of the stent 1 cm an overlapping the proximal 14 cm of the prior stent, covering the unusual appearing filling defect.A post aborted arteriogram showed excellent flow through the stents and no further filling defects.Completion runoff images show patent popliteal, tp trunk and three-vessel runoff with small segmental occlusions from embolism to the foot.However, the foot remains well perfused with now palpable pt and dp pulses.The sheath was removed and manual compression providing hemostasis.¿ impression notes from the 7/25/2018 procedure state: ¿impression: unremarkable successful overnight thrombolysis of the popliteal artery and all 3 runoff vessels and pedal arteries.Flow-limiting filling defects within the proximal portion of the stents appear to represent the dehiscence of the stent fabric from the metal, rather than residual thrombus.In retrospect, reviewing the images of the initial placement 2 months ago, this is apparent on the immediate post placement images with wasting of the contrast column and frank narrowing of the contrast column away from the metallic portions of the stent in a spiraling pattern.I am reasonably certain that this is the reason for the early thrombosis.Any case, it appears to be repaired by the newly placed covered stent, as described above.¿ the records indicate a ¿clot w/i filter wire vs gortex [sic] from the stent¿ specimen was collected during the procedure and sent to surgical pathology.The 7/25/2018 records indicate a gore® viabahn® endoprosthesis (vbjr081502a/15822077) was used during the procedure.A surgical pathology report regarding the specimens collected 7/25/2018 states: ¿clinical information: covered stents placed two months ago, arteriogram after thrombolysis, looked like cortex [sic] had been torn free from metal stent, small clot or other retrieved.Specimen received: left popliteal artery stent.¿ the surgical pathology report provides the following gross description of the 7/25/2018 specimen: ¿received without fixative labeled [patient¿s name] is a 0.3 x 0.3 by less than 0.1 cm aggregate of tan, irregular possible soft tissue, submitted in toto in one cassette.¿ ¿final pathologic diagnosis: left popliteal artery stent soft tissue, excision: organizing blood and fibrin consistent with clot.¿ there is no gross description of a ¿left popliteal artery stent¿ in the surgical pathology report.Records dated 7/26/2018 state: ¿80 [year old] male [status post] l popliteal artery stenting [status post] cdt and relining of stent.Doing very well, leg no longer appears threatened.- no evidence of complication from the lysis.- improving physical exam, lle/foot appears near-normal.- ok for [discharge] from ir perspective.¿ discharge records dated 7/26/2018 state: ¿the patient is an 80-year-old male with a history of bilateral popliteal aneurysms, most recently receiving a left popliteal stent in may of this year.The patient emergently began to experience left lower extremity leg cramping with motor and sensation issues and went to his local hospital emergency department at iu bloomington.It was there that it was confirmed that the patient did have a left lower extremity ischemia.He was started on a heparin drip.He remained pulseless and was transferred up here to methodist.¿ the 7/26/2018 discharge summary records continue: ¿the patient was then admitted to methodist on the 24th of july 2018.He did remain on heparin drip during this time and was able to undergo ct angiography of his lower extremity, which did reveal a thrombosis of his left popliteal stent.During this time, interventional radiology was consulted for lysis procedure.He underwent multiple stages of lysis of his thrombosed left popliteal stent on the 24th to 25th and also underwent a repeat stenting and angioplasty as well.After his procedures and take backs were completed, he did have a successful 3-vessel runoff with return to sensorium and motor function to his lower extremity.During this time, the patient continued to remain in the intensive care unit and remained hemodynamically stable.He did complain of having some mild hematuria during this time, which was emphasized as normal for lysis procedure.However, he continued to remain asymptomatic.He continued to remain on a little bit of oxygen therapy, which was slowly being weaned and he was started on plavix and therapeutic lovenox for bridging to coumadin for his atrial fibrillation.It did appear also that his inr levels were slightly decreased upon admission as well.He then continued to progress towards discharge home, which eventually occurred on the 26th of july 2018.¿ the 7/26/2018 discharge records provide the following discharge diagnoses: ¿1.Peripheral vascular disease.2.Bilateral popliteal aneurysms with recent left popliteal thrombosed stent.3.Hypertension.4.Hyperlipidemia.5.Atrial fibrillation.6.Chronic obstructive pulmonary disease.7.Tobacco use disorder.¿ images and the specimens collected during the 7/25/2018 procedure have been requested for evaluation.It should be noted that the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use provide the following intended use / indications: ¿the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 6.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 ¿ 12 mm.The gore® viabahn® endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (av) access grafts.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding sizing and selection: ¿when overlapping (telescoping) multiple devices, the following are suggested: ¿ balloon touch-up (post-dilatation) should be performed on the first device prior to placing the second device.¿ to ensure proper seating, at least 1 cm of overlap between devices is suggested.¿ overlapping devices should not differ by more than 1 mm in diameter.¿ if unequal device diameters are used, the smaller device should be placed first and then the larger device should be placed inside of the smaller device.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state: ¿w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral, iliac arteries or the venous anastomosis of the arteriovenous (av) access circuit.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use continue: ¿w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.No device migrations or fractures were detected in 25 devices placed across the antecubital fossa in the avr 06-01 clinical study and patency rates were comparable to those of the entire gore® viabahn® endoprosthesis cohort.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding procedure related complications: ¿as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and / or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and / or death.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding device related complications: ¿complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and / or rupture; false aneurysm; infection; inflammation; fever and / or pain in the absence of infection; deployment failure; migration; and device failure.¿ 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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Event Description
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The patient reported he is doing well.He stated he had duplex imaging done recently and ¿leg looks great.¿.
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Manufacturer Narrative
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B5: added patient update.H6: added two additional patient codes.H6: added method codes.H6: added results code 4247 for the imaging evaluation.Code 4247 is being used for "distal occlusion of the viabahn." h6: updated conclusion codes.Code 4315 is being used for "dehiscence of the stent fabric from the metal." h10/11: added specimen and imaging evaluation information.Operative records dated (b)(6)2018 indicate specimens were collected during the procedure.The hospital was contacted regarding the specimens, and it was reported that only tissue samples from around the gore devices were collected during the (b)(6)2018 procedure.It was reported no devices were removed from the patient during the (b)(6)2018 procedure, and there was no gross description of a "left popliteal artery stent" in the surgical pathology report.The(b)(6)2018 tissue specimens were not retained by the hospital and were unavailable for evaluation.Images were returned to gore and an imaging evaluation was performed.The imaging evaluation found the following: angiogram dated (b)(6)2018 illustrates what appears to be two (2) patent viabahn devices.3d reconstruction from ct dated (b)(6)2018 illustrates that the distal viabahn appears to be occluded.Axial image from ct dated (b)(6)2018 illustrates that the distal viabahn appears to be occluded.Angiographic image dated (b)(6)2018 illustrates a distal occlusion of the viabahn.Angiographic image dated (b)(6)2018 illustrates a distal occlusion of the viabahn and what also appears to be poor distal runoff.Post thrombolysis angiographic image dated (b)(6)2018 illustrates that the viabahn appears to be patent.Post thrombolysis angiographic image dated (b)(6)2018 illustrates what appears to be good runoff with patent distal vessels.Per the radiological notes of the complainant¿s interventional procedure performed on (b)(6) 2018 the following was stated: ¿flow-limiting filling defects within the proximal portion of the stents appear to represent the dehiscence of the stent fabric from the metal, rather than residual thrombus.In retrospect, reviewing the images of the initial placement 2 months ago, this is apparent on the immediate post placement images with wasting of the contrast column and frank narrowing of the contrast column away from the metallic portions of the stent in a spiraling pattern.I am reasonably certain that this is the reason for the early thrombosis.Any case, it appears to be repaired by the newly placed covered stent, as described above.¿ due to this review of images provided by the radiology team at iuh methodist hospital, a multi-disciplinary gore team performed additional reviews of the images.The images viewed were from the index procedure in which the gore® viabahn® endoprotheses were initially placed on (b)(6) 2018, and from the reintervention on (b)(6)2018.After reviewing the images, the gore team was unable to reach a conclusion that confirmed or refuted the observation described by the radiologist of the stent material allegedly delaminated or that confirmed another reason for the observations in the imaging.It should be noted that the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use provide the following intended use / indications: ¿the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 ¿ 6.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 ¿ 12 mm.The gore® viabahn® endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (av) access grafts.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding sizing and selection: ¿when overlapping (telescoping) multiple devices, the following are suggested: balloon touch-up (post-dilatation) should be performed on the first device prior to placing the second device.To ensure proper seating, at least 1 cm of overlap between devices is suggested.Overlapping devices should not differ by more than 1 mm in diameter.If unequal device diameters are used, the smaller device should be placed first and then the larger device should be placed inside of the smaller device.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state: ¿w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral, iliac arteries or the venous anastomosis of the arteriovenous (av) access circuit.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use continue: ¿w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.No device migrations or fractures were detected in 25 devices placed across the antecubital fossa in the avr 06-01 clinical study and patency rates were comparable to those of the entire gore® viabahn® endoprosthesis cohort.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding procedure related complications: ¿as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and / or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and / or death.¿ the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use state regarding device related complications: ¿complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and / or rupture; false aneurysm; infection; inflammation; fever and / or pain in the absence of infection; deployment failure; migration; and device failure.¿ 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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