Model Number 500 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/03/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Product analysis: the product specimen was discarded by the user facility.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information that during implant of this aortic mechanical valve, the device dislodged due to the physician using the wrong suture needle.The device was explanted and replaced.No other adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Conclusion: the instructions for use for the open pivot mechanical heart valve has a warning that states ¿it is suggested that only taper point needles be used for suturing the cuff as taper cut or other cutting needles may cut the cuff fibers.¿ this investigation revealed no intrinsic evidence to suggest a root cause related to product quality/performance or manufacturing process.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|