Model Number H7493926016400 |
Device Problem
Defective Component (2292)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/28/2018 |
Event Type
malfunction
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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#: 2134265-2018-02261 and 2134265-2018-03092.It was reported that the balloon looked larger on either side of the stent.The target lesion was located in the circumflex artery.After engaging the lesion with a non-bsc guide catheter and a guidezilla guide extension catheter, a 4.00x12mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device was not placed correctly and the physician then pulled the stent back through both devices.As the physician put the stent back in, the stent got stripped off the balloon at the transition, at the collar of the guidezilla.The stent was removed with the balloon together.Furthermore, a 4.00x16mm synergy ii drug-eluting stent was advanced; however at some point during the procedure, the physician claimed that when the device was removed the balloon looked larger on either side of the stent.Thus, the physician opted not to use the device.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was fine.
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Event Description
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Same case as mdr id#: 2134265-2018-02261 and 2134265-2018-03092.It was reported that the balloon looked larger on either side of the stent.The target lesion was located in the circumflex artery.After engaging the lesion with a non-bsc guide catheter and a guidezilla guide extension catheter, a 4.00x12mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device was not placed correctly and the physician then pulled the stent back through both devices.As the physician put the stent back in, the stent got stripped off the balloon at the transition, at the collar of the guidezilla.The stent was removed with the balloon together.Furthermore, a 4.00x16mm synergy ii drug-eluting stent was advanced; however at some point during the procedure, the physician claimed that when the device was removed the balloon looked larger on either side of the stent.Thus, the physician opted not to use the device.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: synergy ii us mr 4.00 x 16mm stent delivery system was returned for analysis without a stent.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal marker bands.The crimped stent outer diameter was measured and was within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A balloon inflation/deflation test was then performed.The device was inflated to rated burst pressure using an encore inflation device.The balloon was inflated and stent expanded with no issues and when a vacuum was pulled the balloon deflated in 8 seconds this is within deflation time specification.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion found no issues.A visual and microscopic examination of the tip found damage to the tip edge.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Search Alerts/Recalls
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