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This follow up report is being submitted due to the completion of the investigation of this event.Initial description submitted as follows: "global study 12-004 site 101 patient (b)(6) original procedure date (b)(6) 2014.Right distal sfa was treated with one zilver ptx study stent, discharged same day.Adverse event reported worsened claudication/rest pain.Physician indicated "possibly related to study product".(b)(6) 2014 (133 days post procedure) re-intervention in study lesion (balloon/stenting), patient discharged same day.No further adverse effects to the patient have been reported as occurring.".
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The (b)(4) device involved in this complaint was not available for evaluation (the stent remains implanted in the patient).With the information provided a document based investigation was carried out.Additional information was requested in order to determine if the reported event (worsen claudication/rest pain) was the symptom of underlying issue such as restenosis or thrombosis.This could not be determined however the following additional information was provided.On the ae form, the question, "did a pre-existing condition cause or contribute to the event" was answered as "yes - atherosclerosis".The question, "did the device malfunction or deteriorate in characteristics or performance" was answered as "no".In addition to the above, angiographic images were available and were reviewed as follows."the ptx stent was placed inferior a long linear dissection with residual 50% diameter stenosis (3mm residual lumen) over 6cm that was left untreated.This coupled with the patient's continued tobacco abuse were significant reasons for recurrent/progressive disease".Based on the image review and customer testimony the complaint was confirmed.From the available complaint information and based on the image review, it can be stated that it is unlikely that the reported event occurred zilver ptx stent due to malfunction.Worsened claudication /rest pain are the symptoms of progressing peripheral artery disease atherosclerosis, untreated lesion as well as continued tobacco abuse most likely caused or contributed to this event.However, as the conditions of use cannot be replicated in the laboratory settings a definitive root cause of this event cannot be determined.It may be noted that as per instruction for use worsened claudication / rest pain are noted as a potential adverse events associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.According to information provided, re-intervention in study lesion was performed and the patient was discharged same day.No further adverse effects to the patient have been reported as occurring.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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The ziv6-35-125-6-80-ptx device involved in this complaint was not available for evaluation (the stent remains implanted in the patient).With the information provided a document based investigation was carried out.Additional information was requested in order to determine if the reported event (worsen claudication/rest pain) was the symptom of underlying issue such as restenosis or thrombosis this could not be determined however the following additional information was provided: on the ae form, the question, ¿did a pre-existing condition cause or contribute to the event¿ was answered as ¿yes ¿ atherosclerosis¿.The question, ¿did the device malfunction or deteriorate in characteristics or performance¿ was answered as ¿no¿.In addition to the above, angiographic images were available and these were reviewed by med institute.The following impression from this review was provided by the independent reviewer: ¿the ptx stent was placed inferior a long linear dissection with residual 50% diameter stenosis (3mm residual lumen) over 6cm that was left untreated.This coupled with the patient's continued tobacco abuse were significant reasons for recurrent/progressive disease.¿ a subsequent complaint was raised (b)(4) capturing worsened claudication of right lower extremity 757 days post-procedure.Additional imaging and review was provided related to (b)(4)through cook research inc.(cri) and the following comments were provided by the independent reviewer: findings: implantation angiography is provided.Three month follow up ultrasound just prior to a secondary intervention is provided however the secondary intervention angiography is not provided.One year follow up x-rays and ultrasound is provided.Two year follow up ultrasound is provided.The target lesion was a 12cm long heavily calcified severe mid and distal sfa stenosis.The sfa proximal and distal the stenosis was moderately to severely narrowed secondary to collapse from reduced perfusion pressure and atherosclerotic plaque.The stenosis was angioplastied and then only the distal 8cm was stented.This left a proximal long deep post angioplasty dissection with residual stenosis greater than 30% and a distal mild stenosis.Inflow was significantly limited by a 50% right external iliac artery (eia) origin stenosis.Complete imaging of the runoff into the right foot was not provided.The right posterior tibial artery was widely patent to the mid distal calf.The anterior tibial and posterior tibial arteries occluded in the proximal calf.The three month post implantation ultrasound demonstrated a hemodynamically significant stenosis at the distal right common iliac artery (cia) extending into the eia origin.Peak systolic velocities (psv) were elevated to 297cm/sec indicating a 50-99% stenosis.At the stent distal end, a long mild to moderate 25- 50% stenosis was present on duplex ultrasound.No pulse wave doppler interrogation of the stenosis was provided.Although imaging of the subsequent intervention was not provided, the year follow up x-ray demonstrated that during this intervention a second 6x80mm zilver ptx stent had been implanted.It overlapped the distal stent by 20mm extending an additional 60mm distally.It presumably covered the long mild to moderate stenosis demonstrated by ultrasound.The year follow up ultrasound demonstrated no stenosis greater than 50% from the distal right eia through both stents to the popliteal artery.Two year follow up ultrasound demonstrated focal increased psv on pulsewave doppler in the distal stented segment to 308cm/sec.However if this stenosis had been severe as a psv of 308cm/sec suggested, a significantly narrowed appearance and turbulence on duplex doppler (gray scale and color flow doppler combined) would have been expected.Instead no gray scale abnormality was present and the color flow doppler turbulence is minimal.Consequently, whether a severe stenosis was present is questionable.Even a web-like stenosis typically produces a greater disturbance on color flow doppler.No imaging of the cia or eia was provided to determine the status of the inflow limitation.Abi with waveforms at two years demonstrated claudication range pressures on the right and moderate waveform degradation compared to the left.This indicated a significant right stenosis.However, the left was also abnormal although less so.Given the bilateral symptoms and the reported persistent tobacco abuse, an aorta iliac lesion may have developed.Impression: a stenosis in the distal stented segment was present on pulsewave doppler ultrasound at two years.Whether the stenosis was greater than 50% and responsible for the patient's recurrent claudication and abnormal abi cannot be determined.First, the stenosis was much less severe on duplex ultrasound.Second, recurrence or persistence of the right iliac inflow limitation cannot be excluded.Third, the presence of bilateral symptoms could reflect a new proximal aortic iliac lesion particularly given the history of continued tobacco abuse.The complaint event (b)(4) likely occurred in the zilver ptx stent implanted at the secondary intervention and not the original study stent.(b)(4) was related to the secondary intervention and occurred before (b)(4).It was a long mild to moderate stenosis beginning at the original study stent distal end.Because the stenosis was stented, it likely had progressed to an angiographically significant stenosis.This stenosis occurred downstream a significant iliac artery stenosis and a significant residual dissection proximal the study stent.Although the proximal dissection healed, before healing it may have contributed to the worsening distal stenosis.The iliac stenosis likely worsened and would have contributed to the worsening distal stenosis.Whether the iliac stenosis was treated during the secondary intervention cannot be determined.Significant findings relative to the patient's anatomy were not observed.Significant findings relative to the disease state were observed.Atherosclerotic stenosis progressed as expected with ongoing tobacco abuse.The stenosis distal the original study stent likely progressed.Significant findings relative to the use of the device were observed.The original study stent was implanted in the middle of a long sfa stenosis with limited iliac inflow, significant post angioplasty dissection proximally, and mild stenosis distally.Significant findings relative to the design or performance of the device listed in (b)(4) and (b)(4) were not observed.Significant findings relative to the design or performance of a 6x80mm zilver ptx stent implanted during the secondary intervention were observed.This stent was not identified in the complaint reports but was present on the imaging.This stent developed an in-stent stenosis of indeterminate severity.Cause of adverse events was not observed.The independent reviewer was contacted to clarify the sequence of events outlined above, and the following was received: "the facts of the case are as follows: a 6x80 zilver ptx stent was implanted at the index procedure.Three months later, a stenosis at the distal stent end was observed.This stenosis subsequently was stented during the secondary intervention.No imaging of this intervention was provided.The secondary intervention stent was also a 6x80 zilver ptx.This stent was implanted more distal but overlapping the index stent.At two years, the second stent implanted had developed in-stent stenosis not the index stent.Consequently, there is no pr number for the stent implanted at the secondary intervention.Because both complaints did not involve the index stent, the index stent in a sense is exonerated as the cause of each complaint.The only caveat is the possibility of new index stent involvement by the time secondary intervention was performed.This can only be excluded by evaluation of the secondary intervention imaging.Based on the additional image review finding: ¿(b)(4) (this complaint) was related to the secondary intervention and occurred before (b)(4).It was a long mild to moderate stenosis beginning at the original study stent distal end¿ and the input from the independent reviewer: ¿both complaints did not involve the index stent, the index stent in a sense is exonerated as the cause of each complaint¿ the customer complaint is not confirmed.Worsened claudication /rest pain are the symptoms of progressing peripheral artery disease.Atherosclerosis, untreated lesion as well as continued tobacco abuse most likely caused or contributed to this event.It may be noted that as per instruction for use (ifu0093-4) worsened claudication / rest pain are noted as a potential adverse events associated with the placement of this device.For complaints where it has been determined either through the manufacturer or through clinical opinion that the device functionality did not contribute to the issue, a limited investigation may be completed.Therefore no document review is required.Based on the additional image review received, and based on the input from the independent reviewer, this customer complaint is not confirmed.
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This follow up mdr is being submitted due to the receipt and review of images relating to this event.Initial description submitted as follows: "global study 12-004 site 101 patient (b)(6).Original procedure date: (b)(6) 2014 right distal sfa was treated with one zilver ptx study stent, discharged same day.Adverse event reported: worsened claudication/rest pain.Physician indicated ¿possibly related to study product".(b)(6) 2014 (133 days post procedure) re-intervention in study lesion (balloon/stenting), patient discharged same day.No further adverse effects to the patient have been reported as occurring.".
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