Complications of Carotid Artery Patches: Insight from the MAUDE Database
Wayne Tse, MD, Michael F. Amendola, MD.
VA Medical Center/VCU Health System, Richmond, VA, USA.
OBJECTIVES
The Manufacturer and User Facility Device Experience (MAUDE) Database was established to allow for voluntarily reporting of adverse medical devices outcomes. CorMatrix (CorMatrix Cardiovascular) is a biologic extracellular patch derived from porcine small intestinal mucosa designed to provide a biologic scaffold for cellular ingrowth and eventual tissue regeneration. Pseudoaneurysm formation with this type of biological patch has been described in the carotid and femoral repairs. It is not known the characteristics of carotid repairs complications of this patch type compared to prosthetic grafts in the MAUDE Database.
METHODS
The MAUDE Database was access from January 1, 2008 to July 1, 2018 for entries related to the search term “carotid and patch.” The following variables were obtained: type of graft, physician reporter, days to MAUDE report, adverse events, if the explant was available for evaluation, if the explant was evaluated by manufacturer, mortality, thrombosis complication, aneurysmal degeneration, seroma, infection and if cultures were reported. Fisher’s Exact* and two-tail t-test** were utilized.
RESULTS
A total of 144 entries had complete records. Comparing the CorMatrix to Prosthetic Patch:
| CorMatrix (n=66) | Prosthetic Patch (n=79) | p value | |
| Time to Reporting (days± SD) | 22.7 ± 39.8 | 82.4 ± 110.8 | 0.0001** |
| Patch Explanted (%) | 42.4% | 13.9% | 0.0001* |
| Mortality Reported (%) | 0% | 7.6% | 0.03* |
| Devices Returned (%) | 61.1% | 16.8% | 0.0001* |
| Physician Reporter (%) | 84.8% | 43.0% | 0.0001* |
Of the other entries: if an adverse event occurred (89.4% v. 82.3%; p=0.24**), if the explant was evaluated by manufacturer (9% v. 7.6%;p=0.77), thrombosis complication (9.1% v. 21.5%;p=0.06**), aneurysmal degeneration (21.2% v. 16.4%;p=0.52**), if seroma occurred (1.5% v. 1.2%;p=1.0**), if infection was reported (10.6% v. 17.7%;p=0.24**) and if culture were obtained (1.5% v. 1.2%;p=1.0**) there were no significant different between the CorMatrix and Prosthetic Patch groups respectively.
CONCLUSIONS
In our examination, CorMatrix compared to Prosthetic Patch was found to have an earlier reporting time, more patch explants, more patches returned to manufacturer, fewer deaths and more physician reporters. Interestingly, the rate of aneurysm degeneration as previously described by case report in the literature was not found in the reports from this database. We recommend more uniform and consistent reporting to this quality database to improve an understanding of complications of this and other surgical implants.
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