Catalog Number 1128350-15 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Ischemia (1942); Cardiogenic Shock (2262)
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Event Date 09/06/2019 |
Event Type
Death
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Manufacturer Narrative
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Exemption number (b)(4).The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xience proa device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.
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Event Description
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It was reported that the procedure was performed to treat a proximal left anterior descending (lad) lesion.The 3.50x15mm xience proa stent was implanted successfully.A few hours later, the patient had cardiac shock and needed to be resuscitated.The patient was returned to the cath lab and it was noted there was reduced blood flow in the distal lad.The lesion was dilated using a non-abbott balloon then a 2.75x33mm xience pro stent was placed.The perfusion was restored successfully but due to the cardiogenic shock the circulation couldn't be fully restored, and the patient died.According to the physician the patient died due to protracted cardiogenic shock.In the physician¿s opinion the death was because of the general condition of the patient and not because of the placed stents.No additional information was provided.
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Manufacturer Narrative
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Exemption number e2019001.The device was not returned for evaluation.The reported patient effects of death and ischemia are listed in the xience pro a everolimus eluting coronary stent systems instructions for use, as a known patient effects of coronary stenting procedures a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 respect to manufacture, design or labeling.
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Event Description
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It was reported that the procedure was performed to treat a proximal left anterior descending (lad) lesion.The 3.50x15mm xience proa stent was implanted successfully.A few hours later, the patient had a cardiac shock and needed to be resuscitated.The patient was returned to the cath lab and it was noted there was reduced blood flow in the distal lad.The lesion was dilated using a non-abbott balloon then a 2.75x33mm xience pro stent was placed.The perfusion was restored successfully but due to the cardiogenic shock the circulation couldn't be fully restored, and the patient died.According to the physician the patient died due to a protracted cardiogenic shock.In the physician¿s opinion the death was because of the general condition of the patient and not because of the placed stents.No additional information was provided.
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Search Alerts/Recalls
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