Model Number H74939238601510 |
Device Problems
Bent (1059); Break (1069); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Device is a combination product.(b)(4).
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Event Description
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Same case as mdr id 2134265-2016-09409.(b)(6).The subject was enrolled and the index procedure was performed on (b)(6) 2016.The target lesion located in the right mid superior femoral artery (sfa) with 100% stenosis and was 190 mm long with a reference vessel diameter (proximal 5.0 mm; distal 4.5 mm) and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation and placement of two 6.0 x 150mm eluvia drug-eluting vascular stents.Following post-dilatation, residual stenosis was 10%.The 6.0 x 150 mm eluvia drug-eluting vascular stents (lot 18822230) was advanced to the distal target lesion and was noted that the stent was kinked or deformed stent.The delivery system was attempted to be removed and was pulled forcibly.The stent was noted to be fractured.The second 6.0 x 150 mm study stent with (lot 18822232) was advanced to the target lesion and was noted that the stent was kinked or deformed stent.The delivery system was attempted to be removed and was pulled forcibly.The stent was noted to be fractured and the deployment wheel was broken.The procedure did not lead to a serious adverse event.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of an eluvia stent delivery system (sds) with a non-bsc guide sheath.The sds was in the lumen of the guide sheath, the guide sheath was 2.5cm from nose cone and 2.5 cm from distal end.The tip of the guide sheath was damaged.The handle of the sds was not returned.The middle shaft was detached from the clip.There was 120mm of stent in the sheath.The distal end of the returned stent had stretched stent struts and was separated.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The reported stent separation was confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was further reported that during deployment of second stent (18822232), a non-bsc.014 guide wire was advanced from distal using wire rendez-vous technique and became entrapped in the fractured stent.A 5mm portion of the guide wire remained in the vessel.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that the stent fracture was noted only for stent (18822232) and not for stent (18822230).
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that both stents (b)(4) and (b)(4) appeared fractured during six month follow up visit.
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Search Alerts/Recalls
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