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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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The physician in this case consented to participate in the survey but did not consent to be contacted regarding the information provided and wished to remain anonymous, therefore information for facility and city cannot be provided.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 endeavor resolute rx coronary drug-eluting stent.Survey results from an interventional cardiologist in practice 19 years.In the past 12 months, the physician has used the endeavor resolute stent 130 times.30 of the smallest (2.25 x 8 mm), 50 intermediate (2.25 x 12 mm to 4.00 x 34 mm) and 50 of the largest sizes (4.00 x 38 mm) of these stents were used.It was noted that the device was used in other non-coronary procedures including 40 devices being used to treat the femoral artery.The following device complaints were encountered in procedure when using the endeavor resolute product over the last 12 months: it was reported that the device did not perform as expected in terms of reaching the target lesion in 90 events due to the coronary system being too severely calcified it was reported that the device did not perform as expected in terms of dilation of the target lesion in 20 events due to the system being too busy/challenging.
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Search Alerts/Recalls
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