Model Number H7493911328220 |
Device Problem
Bent (1059)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/19/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device is a combination product.(b)(4).
|
|
Event Description
|
It was reported that stent damage occurred.The 88% stenosed target lesion was located in the distal left circumflex artery.A 2.25x28mm promus element ¿ drug-eluting stent was advanced but failed to cross the lesion.During withdrawal, the stent struts were noted to be lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: promus element mr ous 2.25 x 28mm stent delivery system was returned for analysis.A visual examination of the stent identified damage.The first distal strut row was lifted and pulled proximally.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The bumper tip of the device was examined and damage was noted.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube revealed no issues.An examination of the shaft polymer extrusion identified no issues.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
|
|
Event Description
|
It was reported that stent damage occurred.The 88% stenosed target lesion was located in the distal left circumflex artery.A 2.25x28mm promus element drug-eluting stent was advanced but failed to cross the lesion.During withdrawal, the stent struts were noted to be lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
|
|
Search Alerts/Recalls
|