The product was not returned to abbott vascular for analysis.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 other incidents and/or complaints reported from this lot.In this case, the device was prepped prior to use without any leak noted, which would suggest that the device was not damaged prior to use.The reported patient effect of occlusion and embolism are listed in the instructions for use (ifu) percutaneous transluminal angioplasty (pta), armada 35 / armada 35 long length global, as known patient effects of the procedure.The investigation determined the reported balloon rupture, difficulty to remove and tip separation appear to be related to case circumstances.In this case, it is likely that the balloon outer surface became compromised and/or damaged during advancement and/or inflation against the stenosed anatomy resulting in the balloon rupture.Due to the balloon rupture the balloon was not able to properly refold causing the difficulty to remove.Manipulation against resistance resulted in the tip separation.Additionally, the reported treatment appears to be related to the operational context of the procedure as unsuccessful attempts were made to snare the device tip which caused an occlusion and the tip embolized in the left pulmonary artery; however, the patient is doing well and feeling fine.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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