No samples were returned for investigation for these nine (9) summarized events.The product referenced in article is "6-ply cormatrix extracellular matrix" which is currently branded as the aziyo product "vascure for vascular repair." manufacturing review of the vascure for vascular repair device history records for the respective events could not be completed as the lot/serial numbers were not provided.It is noted that per the instructions for use (ifu - art-20708a) provided with the finished vascure for vascular repair device, stenosis is listed as a potential complication associated with the procedure and device.No further information is available for the reported events, should any additional information be received, a follow-up report will be filed.
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During post market surveillance, a published article entitled "long-term results with cormatrix extracellular matrix patches after carotid endarterectomy." j surg res.2021 jun; 262:21-26 was reviewed and summarized as follows: retrospective study of 275 patients who underwent a total of 291 carotid endarterectomy patch repairs with cormatrix 6-ply patches (model #'s: / lot #'s: unknown) between 2011 and 2015.The purpose of the article was to demonstrate utilization of consistent technique using 6-ply graft only including a one minute hydration interval in saline on the rate of formation of pseudoaneurysm at the repair site.The conclusions of the authors was that a truncated period of soaking the patches in saline and the use of 6-ply patches appear to mitigate the risks of pseudoaneurysm formation in the carotid artery position.The authors' experience with cormatrix 6-ply patches was "very favorable".In addition to reporting the incidence rate of pseudoaneurysms, the article also reflects the following outcomes from the 275 patient cohort: reportable outcomes included thirteen (13) events of restenosis requiring reintervention (e.G.Re-do procedure, stent placement or not referenced) and one pseudoaneurysm event.Review of filed mdrs files indicate that five (5) of these events had been previously reported by the authors or institution (mdrs 2014-00047 - 2014-00050 [restenosis], 2015-00001 [pseudoaneurysm]).Of the 13 patients with restenosis, eleven (11) had carotid stents placed and two (2) had repeat carotid endarterectomies.It is not known which patients (of those previously reported) had which intervention to resolve this event.One patient is described as having stenosis above the endarterectomy site.A second patient is described as having a dissection involving the distal common carotid artery.Follow-up with one of the authors was received regarding the recurrent stenosis events, stating "the recurrent stenoses are not unique to the cormatrix patches.They are seen with all patches".An excel spreadsheet with table summarizing the additional nine (9) reports of stenosis has been attached to this filing.No additional information is forthcoming regarding these 9 restenosis events not previously reported, or filed in 2014.As no previous "re-do" procedures were reported in previous filings, a re-operation code has been included in the summary table.
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