The device was not returned 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 did not indicate a lot specific quality issue.It was reported that the graftmaster was deployed with a maximum pressure of 19 atmospheres (atm).It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use, specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.It is unknown if the ifu deviation contributed to the reported event.The reported patient effect of death, as listed in the graftmaster rx coronary stent graft system, instructions for use, is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.The patient health was already declining toward death as soon as the lesion perforated.The patient then went into asystole and cardiopulmonary resuscitation (cpr) was performed for 45 minutes but the patient died due to the perforation.In the opinion of the physician, the use of the graftmaster did not cause or contribute to patient's asystole or death in any way.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak; however, the subsequent unexpected medical intervention (additional therapy/non-surgical treatment) appears to be related to the operational context of the procedure.The reported patient effect of unrelated death was due to the perforation and not related to the device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect - clinical code 1762 removed; 4582 added.
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