It was reported that the procedure was performed to treat a 90% stenosed, moderately tortuous, heavily calcified, and chronic totally occluded lesion in the first and second diagonal artery and a 90% stenosed, heavily tortuous, heavily calcified, and chronic totally occluded lesion in the obtuse marginal artery.Following thrombus aspiration, pre-dilatation was performed with a 2.5x20mm nc trek balloon dilatation catheter (bdc) and a 2.5x48mm xience stent was deployed without issues.A 2.5x15mm nc trek bdc was advanced to the second diagonal artery and a 2.5x20mm nc trek bdc was advanced to the anterior descending artery to perform kissing balloon angioplasty; however, the 2.5x15mm bdc was inflated to 12 atmospheres (atms) and the balloon ruptured.The bdc was removed and new unspecified device was used successfully.A 2.25x15mm balloon was advanced to the first diagonal artery, but the balloon ruptured when inflated to 12 atms.The bdc was removed and new unspecified device was used successfully.A 2.5x20mm nc trek bdc was advanced to the obtuse marginal artery and inflated to 12 atms, but again the balloon ruptured.The bdc was removed and a 3.0x20 non-abbott balloon was used successfully.The procedure was successfully completed with the deployment of a 3.0x33mm xience stent and post-dilatation with a non-abbott 3.5x12 bdc.Final timi iii flow was achieved.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation determined the reported complaint appears to be related to operational context.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the moderately tortuous, heavily calcified, and chronic totally occluded lesion such that the balloon became damaged and subsequently ruptured during inflation.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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