Model Number 500FA25 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/05/2014 |
Event Type
Injury
|
Event Description
|
Medtronic received information that during the attempted implant of this mechanical heart valve, the suturing ring separated from the valve body.The valve was removed and successfully replaced by another valve.Additional information was received that the suturing ring separated during the suturing process.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).
|
|
Manufacturer Narrative
|
Review of the device history record showed that this device was built to specification and met all inspection and acceptance criteria.There were no non-conformances or reworks/deviations noted that would have impacted this event.Specifically, no anomalies were noted with regard to the sewing cuff assembly process.
|
|
Manufacturer Narrative
|
The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.It was reported that a cutting needle was used during the procedure and that the suturing ring separated during the suturing process.The instructions for use for this device have a warning that states: ¿when securing the valve in place, suture needles should be passed through the outer half of the sewing cuff and suture ends should be cut short after the knots are tied.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.¿ however, the valve was not returned for analysis, therefore a conclusive cause of the reported event could not be determined.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|