Model Number H7493918424400 |
Device Problems
Premature Activation (1484); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/09/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
|
|
Event Description
|
It was reported that the stent was deployed prematurely and dislodgment occurred.Vascular access was obtained via the femoral artery.The 4.0 x 22mm in length, de novo target lesion was located in the non tortuous and severely calcified left anterior descending artery.A 4.00 x 24mm promus element¿ plus drug-eluting stent was advanced to treat the lesion.However, it was noted that the half of the stent was deployed in the catheter.The whole stent delivery system was removed.Stent came out with the catheter, but the stent is not intact in the balloon system.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable and doing good.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: promus element plus,mr,ous 4.00x24mm stent delivery system (sds) was returned for analysis with the stent detached from the device.Stent detached from sds.One end of the stent was damaged with stent struts squashed.Minimal damage received on the other end of the stent.The undamaged stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon was reviewed.There was no stent on the balloon.The balloon folds were present but were not tightly wrapped; it did not appear that the balloon had been subjected to positive pressure.Crimp markings were evident on the balloon indicating correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found no damage.No other issues were identified during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
|
|
Event Description
|
It was reported that the stent was deployed prematurely and dislodgment occurred.Vascular access was obtained via the femoral artery.The 4.0 x 22mm in length, de novo target lesion was located in the non tortuous and severely calcified left anterior descending artery.A 4.00 x 24mm promus element plus drug-eluting stent was advanced to treat the lesion.However, it was noted that the half of the stent was deployed in the catheter.The whole stent delivery system was removed.Stent came out with the catheter, but the stent is not intact in the balloon system.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable and doing good.
|
|
Search Alerts/Recalls
|