Catalog Number UNK XIENCE PROA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Pain (1994)
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Event Date 02/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant: estimated.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of hypertension, angina, pain and hypersensitivity are listed in the xience pro a everolimus eluting coronary stent systems instructions for use (ifu) as 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.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 in 2018, a xience pro a stent, and a non-abbott stent were implanted.Months after the implantation of the stents, the patient developed hypertension, headache, chest pain, pain in the shoulder joint and pain in the cervical spine.The patient¿s cardiologist assumed that the symptoms could be triggered by a metal allergy.No additional information was provided.
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Search Alerts/Recalls
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