Catalog Number UNK ABSORB |
Device Problems
Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 08/01/2014 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Estimated date of event.Estimated date of implant.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The adverse events referenced are being filed under a separate medwatch report number.The additional xience referenced being filed under a separate medwatch report number.Literature : the relationship of pre-procedural dmax based sizing to lesion level outcomes in absorb bvs and xience ees treated patients in the aida trialna.
|
|
Event Description
|
It was reported through a research presentation identifying absorb bvs and xience stents that may be related to the following: myocardial infarction, thrombosis, revascularization, rehospitalization.Deployment difficulty was also noted for both absorb bvs and xience stents.This article summarizes clinical outcomes of (b)(4) patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "the relationship of pre-procedural dmax based sizing to lesion level outcomes in absorb bvs and xience ees treated patients in the aida trial.".
|
|
Manufacturer Narrative
|
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 part and lot numbers were not provided.It should be noted that the ifu states: size the reference target lesion diameter appropriately to avoid over expanding the scaffold to ensure adequate scaffold apposition.This will reduce the risk of causing scaffold damage.It is unknown if the ifu deviation contributed to the reported difficulty.Based on the information reviewed, a conclusive cause for the reported difficulties could not be determined.The treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|