Exemption number e2019001.The device was not returned for evaluation.A review of the electronic lot history record (elhr) revealed no nonconforming material records (ncmr).Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with r espect to manufacture, design or labeling.
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It was reported that the procedure was performed to treat a lesion in the biliary duct artery.It was noted that other non-abbott devices were used in the procedure.An 8.0x19mm omnilink balloon-expandable stent (bes) was advanced to the target lesion, and the stent was successfully deployed.However, the patient experienced cardiac and respiratory failure and the patient went into anaphylactic shock.The patient was successfully treated with adrenaline medication.The physician stated that the stent or a non-abbott device used in the procedure caused the anaphylactic shock.The patient is stable and remains hospitalized.There was no clinically significant delay in the procedure.No additional information was provided.
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