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Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the resolute integrity rx coronary drug-eluting stent.Survey results from an interventional cardiologist in practice 20 years.In the past 12 months, the physician has used the resolute integrity stent 200 times.190 intermediate (2.25 x 12 mm to 4.00 x 34 mm) and 10 of the largest sizes (4.00 x 38 mm) of these stents were used.The following device complaints were encountered when using the resolute integrity product over the last 12 months: positioning difficulties were encountered in two cases, both of which had no clinical/patient impact.It was also reported that in two cases the device did not perform as expected in terms of dilation of the target lesion.It was stated that this was due to calcification and torquing of the vessel with the longer stent being unable to pass the first stent.No patient injury reported.
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Search Alerts/Recalls
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