Model Number H7493926228350 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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Device is a combination product.(b)(4).
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Event Description
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Same case as mdr id: 2134265-2016-06726.It was reported that the stent was explanted.The target lesion was located in the severely tortuous and moderately calcified left main (lm) artery extending to the left circumflex (lcx) artery.After pre-dilatation and implantation of a 3.50 x 28 synergy⠄rug-eluting stent in the lm, a 2.50 x 38 synergy drug-eluting stent was advanced to treat the lesion in the lcx.However, during crossing attempts, the stent fell off.The device was removed from the patient and intravenous ultrasound (ivus) was performed to check the previously implanted 3.50 x 28 synergy stent in the lm.It was then noted that the stent also fell off.Subsequently, stenting was re-done with a 3.5x32 stent and the procedure was completed.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the complaint device was returned for analysis.The stent had detached from the balloon and was returned for analysis stuck to another stent and without the stent delivery system (sds).The stents were separated during analysis.A visual examination found one stent bunched at one end and remaining struts distorted and stretched.The second stent was bunched and creased together into an oval shape.As the delivery system was not returned with the stent, therefore individual assessment of the device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).
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Event Description
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It was reported that the stent was explanted.The target lesion was located in the severely tortuous and moderately calcified left main (lm) artery extending to the left circumflex (lcx) artery.After pre-dilatation and implantation of a 3.50 x 28 synergy¿ drug-eluting stent in the lm, a 2.50 x 38 synergy¿ drug-eluting stent was advanced to treat the lesion in the lcx.However, during crossing attempts, the stent fell off.The device was removed from the patient and intravenous ultrasound (ivus) was performed to check the previously implanted 3.50 x 28 synergy¿ stent in the lm.It was then noted that the stent also fell off.Subsequently, stenting was re-done with a 3.5x32 stent and the procedure was completed.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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