Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906); Activation Problem (4042)
|
Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 08/24/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
|
|
Event Description
|
On (b)(6) 2021, the patient underwent treatment of an unknown etiology using a gore® viabahn® endoprosthesis with heparin bioactive surface.The physician stated he could not fully deploy the stent graft as the deployment line shredded and broke off during deployment.
|
|
Manufacturer Narrative
|
Engineering evaluation: evaluation of the returned product indicates the deployment line is broken.No cause of for the broken deployment line could be confirmed.
|
|
Search Alerts/Recalls
|