Model Number H7493918438250 |
Device Problem
Bent (1059)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/08/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Age at time of event: 18 years or older.Device is a combination product.(b)(4).
|
|
Event Description
|
It was reported that stent damage occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.A 2.50x38mm promus element¿ plus drug-eluting stent was advanced but failed to cross the target lesion.The device was removed and it was noted that the stent was deformed.Another 2.50x38mm promus element¿ plus drug-eluting stent was advanced but also failed to cross the lesion.The procedure was completed with two shorter stents.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Event date corrected from (b)(6) 2016.Device evaluated by mfr: f/g, promus element plus, mr,ous 2.50x38mmmm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found proximal stent damage.The most proximal stent strut was lifted from the stent profile and bent back distally.The crimped stent od(outer diameter) of the undamaged portion of the stent was measured and was 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 tactile examination found no issues with the hypotube.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues.The bi-component bond showed no signs of damage or strain.A visual examination found no damage to the tip.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
|
|
Event Description
|
It was reported that stent damage occurred.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.A 2.50x38mm promus element¿ plus drug-eluting stent was advanced but failed to cross the target lesion.The device was removed and it was noted that the stent was deformed.Another 2.50x38mm promus element¿ plus drug-eluting stent was advanced but also failed to cross the lesion.The procedure was completed with two shorter stents.No patient complications were reported and the patient's status was stable.
|
|
Search Alerts/Recalls
|