Age at time of event: 18 years or older.(b)(4). device evaluated by mfr.: synergy ous mr 2.75 x 28mm returned for analysis; the stent delivery system was not returned for analysis.A damaged stent (severely stretched), was returned caught of the distal end of a non-bsc balloon catheter.Per the hub of this returned catheter (2.75/12), the balloon of this returned catheter was broken into two sections - the returned stent was caught on the distal section of the bunched balloon.A synergy stent delivery catheter was not returned.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 operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
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Reportable based on device analysis completed on 29jun2018.It was reported that balloon inflation issues occurred.Vascular access was obtained via femoral artery.The 95% stenosed, 28mm x 2.75mm, eccentric, de novo target lesion with a bend of more than 45 degrees and less than 90 degrees was located in the mildly tortuous and mildly calcified coronary artery.A 2.75 x 28 synergy¿ stent was advanced for treatment.However, stent system balloon failed to inflate.The device was removed and the procedure was complete with another 2.75 x 28 synergy¿ stent.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed detached/separated stent and stent damage.
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