|
Model Number 9390 |
Device Problem
Positioning Problem (3009)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/23/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device is a combination product.Device evaluated by mfr.: promus element plus, mr, ous 2.25 x 28 mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with struts along the proximal end lifted and pulled distally.The undamaged crimped stent outer diameter was measured within maximum crimped stent profile measurement.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 microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
|
|
Event Description
|
Reportable based on device analysis completed on 29jul2020.It was reported that stent positioning difficulties were encountered.The diffusely stenosed target lesion was located in the severely tortuous left anterior descending artery.After a guidewire crossed the lesion and pre-dilatation was performed, a 2.25x28mm promus element plus drug-eluting stent was advanced for treatment.However, the stent could not be placed accurately despite several attempts due to tortuousity.The stent was retrieved and the procedure was completed with another of the same device.There were no patient's complications nor injuries reported and the patient status was stable.However, returned device analysis revealed stent damage.
|
|
Search Alerts/Recalls
|
|
|