Catalog Number 123FPP |
Device Problem
Difficult or Delayed Activation (2577)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/17/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned.
|
|
Event Description
|
It was reported that during the procedure, the subject stent was partially deployed when advanced through the catheter.No patient consequences were reported due to this event.
|
|
Event Description
|
It was reported that during the procedure, the subject stent was partially deployed when advanced through the catheter.No patient consequences were reported due to this event.
|
|
Manufacturer Narrative
|
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was returned for analysis and visual inspection revealed the flow diverter was contained in the delivery catheter.There were no anomalies noted to the deployed flow diverter.Functional testing did not reveal any anomalies during analysis.Information available indicated that the device was confirmed to be in good condition prior to use.The reported event is covered in the device directions for use (dfu).The risk of the reported event has been addressed in the risk documentation and there are current controls in place to mitigate the risk of the as reported event.The reported issue could not be confirmed through the investigation however it is likely the stent was re-captured into the delivery catheter prior to the product return, therefore, a cause of procedural factors will be assigned to the investigation.
|
|
Manufacturer Narrative
|
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the additional information indicated that the device was in good condition during preparation/prior to use on the patient.The patient¿s anatomy was severely tortuous.It is probable that the severe tortuosity of the patient¿s anatomy caused the reported event.A probable cause of procedural factor was assigned to the as reported event of sent partial deployment, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the direction for use (dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.
|
|
Event Description
|
It was reported that during the procedure, the subject stent was partially deployed when advanced through the catheter.No patient consequences were reported due to this event.
|
|
Search Alerts/Recalls
|