Advice
Summary of medical device reports
Selection criteria and categorisation
A search of the FDA MAUDE database identified 307 MDRs relating to use of the PROPATEN vascular graft in 332 procedures.
Initially, records of 140 procedures were excluded for the following reasons:
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42 suspected duplicates
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84 procedures with clinical indications that were outside of the scope (such as paediatric shunt or arteriovenous access for dialysis)
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14 procedures carried out in an anatomical location not typically associated with peripheral arterial disease.
The remaining 234 procedures were allocated into these 4 categories:
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Known clinical indication associated with peripheral arterial disease (such as claudication), in the lower limb (n=57)
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Relevant clinical indication but unreported anatomical location (n=4)
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No indication reported (other than "bypass" in some cases) but known lower limb procedure (n=141)
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Neither indication nor anatomical location reported (n=32)
Figure 1 illustrates the above MDR selection process.
