Model Number H74939054088020 |
Device Problem
Bent (1059)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/14/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Age at time of event: 18 years or older.(b)(4). device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed. bsc id: (b)(4).Tw: (b)(4).
|
|
Event Description
|
It was reported that stent damage occurred.The target lesion was located in the iliac vessel.A 8x80x120mm epic¿ stent was advanced and deployed in the lesion.However, it was noted that the stent was deformed.Three additional epic stents were deployed to cover the deformed stent and the procedure was completed.No patient complications were reported and the patient's status was stable.
|
|
Search Alerts/Recalls
|