204 | Chapter 8 Table 2. Device lifetime of the PVHP Subject Device lifetime (days) Reason for replacement Visual inspection VP Acceptance after ending study 1 31 Transprosthetic leakage Biofilm formed on silicone parts. Small leakage detected. No 2 101 Transprosthetic leakage Some residues on sealing surface that came off after cleaning. No leakage detected. No 3 120 Transprosthetic leakage Fungus ingrowth on all silicone surfaces exposed to the esophageal side. Small leakage detected. Yes 4 27 Lost VP during brushing No damages or leakage detected No 5 52 Transprosthetic leakage Residue on sealing surface No 6 370 End of study Residues on sealing surface. Small leakage detected. Yes 7 26 Transprosthetic leakage Difficult to clean, residues on sealing surface close to hinge. Small leakage detected. No 8 64 Periprosthetic leakage Residues on sealing surface that came off after cleaning. No leakage detected. No 9 § 22 Periprosthetic leakage No damages or anomalies No 10 151 Lost VP during brushing N/a Yes, but prefers ActiValve Light 11 367 End of study Residues on sealing surface. Small leakage detected. Yes 12 § 14 Periprosthetic leakage Biofilm on silicone parts. No 13 91 Transprosthetic leakage VP not returned Yes 14 343 End of study Small leakage detected. Leakage stopped after cleaning Yes 15 27 Periprosthetic leakage Residues on sealing surface that came off after cleaning. No leakage detected. No § Did not participate in long-term study
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