Date of event: date estimated.
The device was not returned for evaluation.
A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.
A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.
There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
The additional device is filed under a separate medwatch report number.
|
It was reported that (b)(6) 2021, a procedure was performed to treat the obtuse marginal artery without issues.
A xience sierra stent was successfully implanted without issues.
Approximately one week later, the patient experience contact dermatitis.
On (b)(6) 2021, the patient underwent an additional procedure to treat the left anterior descending artery.
A xience sierra stent was successfully implanted.
However, after the procedure, the contact dermatitis worsened.
The physician did not know what caused the allergic reaction.
No additional information was provided.
|