Model Number S-60-150-120-P6 |
Device Problem
Stretched (1601)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/28/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be user related.Based on the information provided, a definitive cause for the difficulties could not be determined.It may be possible that pre-dilatation was not enough because of heavy calcification, as noted by the physician, in some locations causing the stent to elongate during deployment; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
|
Event Description
|
It was reported that the procedure was to treat a heavily calcified, 95% stenosed, de novo right superficial femoral artery (sfa) lesion.Pre-dilatation was completed with 2 non-abbott cutting balloons that ruptured.The 6x150mm supera peripheral stent system (ses) was advanced to the lesion and during deployment, due to the heavy calcification, the stent elongated approximately 40%, so the ses including the stent were removed.Another, same sized supera was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
|
|
Search Alerts/Recalls
|
|