Model Number H7493926008400 |
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 08/23/2017 |
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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It was reported that stent migration occurred.The target lesion is located in the right coronary artery (rca).A 4.00 x16 synergy drug-eluting stent was deployed in the distal rca to treat the lesion.The lesion required a shorter stent to be placed more proximal, so a 4.00 x 8 synergy drug-eluting stent was deployed just proximal to the 4.00 x 16mm stent.Upon inflation, everything seemed to be in appropriate position and again a cine shot was taken; however, it was recognized that the 4.00 x 8 stent had migrated proximally by about 15mm.So another 4.00 x16 synergy drug-eluting stent was delivered to cover the distance between the first stent and the second stent; however, upon delivery through the 4.00 x 8mm synergy stent, it caught that stent and pushed it down adjacent to the original 4.00 x 16 synergy stent.The physician then chose to take a high pressure balloon, a 4.5 x 20 apex non-compliant and post dilated both the 4.00 x 16mm and the 4.00 x 8mm synergy stents in those exact positions and that completed the procedure.No further patient complications reported and the patient was safe and sound.
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Manufacturer Narrative
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Device evaluated by mfr.: a synergy ii us mr 4.00 x 8mm stent delivery system (sds) was returned for analysis without a stent.No stent returned.The balloon was reviewed.There was no stent on the balloon and the balloon folds were not present.It appeared that positive pressure was applied to the balloon and a vacuum pulled.No damage was noted to the balloon.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found no issues with the tip.No other issues were identified during the product analysis.The most probable root cause was unable to be determined.(b)(4).
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Event Description
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It was reported that stent migration occurred.The target lesion is located in the right coronary artery (rca).A 4.00 x16 synergy drug-eluting stent was deployed in the distal rca to treat the lesion.The lesion required a shorter stent to be placed more proximal, so a 4.00 x 8 synergy drug-eluting stent was deployed just proximal to the 4.00 x 16mm stent.Upon inflation, everything seemed to be in appropriate position and again a cine shot was taken; however, it was recognized that the 4.00 x 8 stent had migrated proximally by about 15mm.So another 4.00 x16 synergy drug-eluting stent was delivered to cover the distance between the first stent and the second stent; however, upon delivery through the 4.00 x 8mm synergy stent, it caught that stent and pushed it down adjacent to the original 4.00 x 16 synergy stent.The physician then chose to take a high pressure balloon, a 4.5 x 20 apex non-compliant and post dilated both the 4.00 x 16mm and the 4.00 x 8mm synergy stents in those exact positions and that completed the procedure.No further patient complications reported and the patient was safe and sound.
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Search Alerts/Recalls
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