|
Model Number 10674 |
Device Problems
Material Rupture (1546); Material Deformation (2976)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/27/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device is a combination product.
|
|
Event Description
|
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 24x3.00mm promus elite mr stent was advanced to treat the lesion.However, during deployment at 11 atmospheres, dog bone effect was noted on the balloon and when the physician increased the pressure for 32 seconds, balloon ruptured.The stent was successfully deployed and the device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.
|
|
Event Description
|
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 24x3.00mm promus elite mr stent was advanced to treat the lesion.However, during deployment at 11 atmospheres, dog bone effect was noted on the balloon and when the physician increased the pressure for 32 seconds, balloon ruptured.The stent was successfully deployed and the device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the target lesion was concentric, containing <45 degrees bend and pre-dilated with nc balloon.
|
|
Manufacturer Narrative
|
Device is a combination product.B5 - describe event or problem updated.Device evaluated by mfr: p elite ous mr 24 x 3.00 mm stent delivery system was returned for analysis with the hemostatic valve attached to the manifold hub.A red/brown blood like substance was noted inside the closed hemostatic valve.A visual and microscopic evaluation of the stent could not be performed as the stent of the device was not returned as it was deployed at the lesion site.The balloon was reviewed, and signs of positive pressure were noted.However, the balloon folds were not fully expanded, and crimp markings were still visible on the exposed balloon body which is a sign of only partial pressure being applied to the balloon cones.A red/brown blood like substance was noted on the balloon.A visual and microscopic examination of the bumper tip showed signs of damage on the distal end of the tip.A visual and tactile examination of the hypotube shaft found no issues.A red/brown blood like substance was noted in the manifold hub.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen and found no issues.An inflation/deflation test was attempted using an encore device verified with a druck gauge to 16 atm.Gradual loss of pressure in the inflation device was noted and was due to a leak originating in a pinhole on the proximal balloon cone.A review of the media provided could identify the alleged balloon material deformation as a constriction in the mid stent region was identified but with proximal and distal stent regions (and balloon cones implicitly) expanded.This restriction in the mid region is giving the whole stent a dog bone like appearance hence the alleged complaint.No other issues were identified during the product analysis.
|
|
Search Alerts/Recalls
|
|
|