As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 02/2024).Device not returned.
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It was reported through the results of a clinical trial that approximately seven months and four days post index procedure using a drug-coated balloon catheter, restenosis of the target lesion occurred and was successfully treated with standard pta.The target lesion required re-intervention, the re-intervention was successful and the patient recovered.The current status of the patient was not provided.
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