Age at the time of the event: 18 years or older (b)(4).Device evaluated by mfr: returned product consisted of an innova¿ stent for damage.Visual examination showed a kink at the nosecone.The mid-shaft showed multiple areas of kinks and twists.The stent was returned in the device.With the damage on the mid-shaft which houses the stent, most likely the stent would suffer damage due to the damage on the mid-shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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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