(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis with the distal shaft of the sds separated and a strand of balloon peeling was noted on the distal taper.Follow-up with the site determined that the device issues with the sds occurred outside the patient anatomy.The reported difficulty to insert was unable to be tested due to the condition the device was returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to insert.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a moderately calcified and moderately tortuous proximal left anterior descending artery.A 2.5 x 33 mm xience xpedition stent delivery system (sds) was advanced in the anatomy.However, an unspecified whisper guide wire was unable to be inserted through the sds.Therefore, another unspecified xience xpedition sds was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Returned device analysis revealed that the distal shaft of the sds was separated and a strand of balloon peeling was noted on the distal taper.
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