Catalog Number 1017350-48 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/15/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The two xience sierra stents referenced are filed under separate medwatch report numbers.The xience pro is currently not commercially available in the us; however, it is similar to a device sold in the us.
|
|
Event Description
|
It was reported that the procedure was performed to treat a lesion in the proximal right coronary artery.A 3.0 x 12 mm xience sierra stent, a 3.5 x 48 mm xience pro stent and a 4.0 x 18 mm xience sierra stent were implanted in the distal right coronary artery (rca) to proximal rca, in overlapping fashion.It was noted that the stents were underexpanded and additional post dilatation was performed.After additional post dilatation was performed, all stents were noted to be well apposed to the vessel wall.There was no reported adverse patient effect or a clinically significant delay in procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
Internal file number: (b)(4) the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported difficult to deploy (wall apposition); however, the subsequent treatment appears to be related to the circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
|
|
Search Alerts/Recalls
|