Actual Number of Donor Deaths
Confirmation of the specific number of living donor deaths associated with use of the Hem-o-lok clip on the renal artery is challenging without access to the centralized, confidential records that are available only to the manufacturer or regulatory agencies. As noted above, the HRSA-FDA advisory references six deaths, while only four are identifiable in MAUDE. One additional MDR report (1044475-2005-00015) described a nephrectomy that may have been known to be a donor nephrectomy to the FDA, but is not publicly disclosed to be so. Thus, we believe that there are either one or two Hem-o-lok associated donor deaths known to the FDA that have not been reported in MAUDE, but are included in the advisory. An Israeli donor death is documented in the peer review literature, but does not match any of the MAUDE reports. Similarly, a case that occurred in India and was personally reported to one of the authors does not match any of the MAUDE reports. For these reasons, we conclude that at least eight (6 HRSA-FDA deaths + Israeli + Indian) or nine (6 HRSA-FDA deaths + 1 unclassified MAUDE nephrectomy + Israeli + Indian) donor deaths have occurred.