Catalog Number 1500400-23 |
Device Problems
Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
|
Event Date 12/04/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Exemption number e2019001.The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that the procedure was performed to treat a moderately calcified, mildly tortuous de novo proximal right coronary artery that was 90% stenosed.Pre-dilatation was performed with an unspecified balloon.A 4.0x23mmxience sierra stent was deployed and despite full dilatation of the balloon, it was noted via optical coherence tomography (oct) imaging that the stent had poorly apposed to the vessel wall as the vessel was wide.Therefore, a 5.0x12mm rx nc trek balloon dilatation catheter was attempted to be used for post-dilatation, but the balloon ruptured at 6 atmospheres.The balloon catheter was replaced with a same size non-abbott balloon to successfully complete the procedure.Oct imaging confirmed the stent had fully apposed to the wall.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
Based on the additional information received stating the stent used in the case was determined to be a non-abbott stent (ultimaster) and not a xience sierra stent as initially reported, no investigation was performed.There is no indication of a product quality issue with respect to manufacture, design or labeling.Device code 2577 was removed patient code 2199 was removed.
|
|
Event Description
|
It was reported that the procedure was performed to treat a moderately calcified, mildly tortuous de novo proximal right coronary artery that was 90% stenosed.Pre-dilatation was performed with an unspecified balloon.A 4.0x23mmxience sierra stent was deployed and despite full dilatation of the balloon, it was noted via optical coherence tomography (oct) imaging that the stent had poorly apposed to the vessel wall as the vessel was wide.Therefore, a 5.0x12mm rx nc trek balloon dilatation catheter was attempted to be used for post-dilatation, but the balloon ruptured at 6 atmospheres.The balloon catheter was replaced with a same size non-abbott balloon to successfully complete the procedure.Oct imaging confirmed the stent had fully apposed to the wall.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Additional information was received: the stent used in this case was determined to be a non-abbott stent (ultimaster) and not a xience sierra stent as initially reported.
|
|
Search Alerts/Recalls
|