It was reported that the procedure was performed to treat an 80% stenosed, moderately tortuous, and moderately calcified de novo lesion in the right coronary artery.A 3.5x38mm xience alpine stent delivery system (sds) was advanced; however, during the first inflation the balloon ruptured at 4 atmospheres.The sds was removed with the undeployed stent still intact.The procedure was successfully completed with a 3.5x38mm xience alpine stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
The device was returned for analysis.The reported material (balloon) rupture and activation failure were unable to be confirmed.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 material rupture as the reported difficulty was not confirmed during return evaluation.It should be noted that a tear to the outer member was identified, which the account likely misidentified as the reported material rupture and likely caused the reported activation failure.Factors that may contribute to torn outer member include, but are not limited to, interactions with other devices, interaction with lesion calcification and/or lesion tortuosity and user handling.Additionally, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|