It was reported that the procedure was to treat a lesion located in the diagonal branch.Predilatation was performed with a 2.5 mm balloon at 12-14 atmospheres (atm).A 2.5x18mm implant delivery system was prepped.There were no issues encountered while removing the protective sheath.The device was advanced without resistance and positioned into the target lesion; however, the balloon would not inflate during attempted deployment.While inflating the balloon the pressure could not be raised above 6-7 atm without the balloon leaking.The implant was deployed; however, there was significant resistance in withdrawing the balloon from the implant.After withdrawing the balloon a tiny hole was noted.The patient began experiencing transient chest pain and transient no reflow due to spilling of the balloon content (most probably some air bubble) which was treated with nitrates.The flow got better after 1-2 minutes.Another balloon catheter was advanced and successfully deployed the implant.The final patient outcome was good.No additional information was provided.
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(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported inflation difficulty was confirmed.The reported balloon rupture was not tested due to balloon separation.The reported resistance during removal and implant wall apposition could not be replicated in a testing environment as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The reported patient effects of air embolism, occlusion and angina, as listed in the instructions for use (ifu), are known adverse events associated with the use of a coronary implant in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded the following: patient has unusual anatomical variant of the coronary vasculature.Implant placement in the first diagonal and in the lad after predilatation followed by post dilatation.No evidence seen on angio of leak with implant #1 as reported.Based on the information reviewed and analysis of the returned device, it is likely the reported inflation issue/balloon leak were due to the damage (balloon break) in the proximal balloon seal; however a conclusive cause for the proximal seal damage cannot be determined.The reported implant wall apposition and resistance during removal appears to be related to the circumstances of the procedure.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.
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