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.The reported patient effects of pain, edema, headache and hypersensitivity listed in the xience skypoint everolimus eluting coronary stent systems instructions for use 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.The additional xience skypoint stent referenced in b5 and d10 is captured under a separate medwatch #.Attachment: medwatch report # mw5148623.
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A medwatch was received which states: had two cardiac stents implanted on (b)(6) 2023, by dr.(b)(6) at (b)(6) hospital.The description of stents is as follows: stent xience skypoint 2.75mmx23mm rapid exchange everolimus eluting coronary, manufacturer abbott laboratories.Model number 1804275-23; lot number 110184b; description lad 2 (left anterior descending, type 2); stent xience skypoint 2.25mmx12mmrapid exchange everolimus eluting coronary, manufacturer abbott laboratories.Model number 1804225-12; lot number 3011941; description lad (left anterior descending).A few days after the procedure, i started getting swelling on my scalp.The swelling then progressively extended to eyes, face, ears, neck, chest, and hand, and to less extent on other parts of the body.I also feel swelling in internal organs like heart and lungs, etc.Later, i started getting headache, pain in my back and waist as well.I visited the er (emergency room) at (b)(6) on (b)(6) 2023, with severe swelling on my scalp, face, eyes and shoulders.I was prescribed prednisone, diphenhydramine and amoxicillin-clavulanate.I was advised to meet with my cardiologist and allergy specialist which i did.After completing the course of drugs prescribed by er, i started taking cetirizine 20 mg twice daily as recommended by dr.(b)(6) (allergy specialist).After two weeks of taking cetirizine 20 mg bd (twice per day), the swelling is reduced.However, i continue to have swelling occurring in different parts of the upper body at different times (it comes and goes in eyes, face, scalp, arms, ear lobes, thigh etc.).The pain in back and waist and headache continues.Due to swelling in eyes my vision is also impacted.Overall, this has adversely impacted my life.I also have another cardiac stent which was implanted on (b)(6) 2023.The description of the stent is as follows: stent coronary 3x26mm onyx frontier rx drug eluting.Model: onyxng30026ux; lot: 0011654032.Description: rca (right coronary artery).I did not get an allergic reaction after this stent was implanted.Reference report: mw5148624.Subsequent to receiving the medwatch form, additional information was provided: the non-abbott stent was implanted on (b)(6) 2023.The patient was hospitalized for one day on (b)(6) 2023 due to the symptoms.The symptoms have not resolved and the patient is receiving treatment for the allergic reaction symptoms.No additional information was provided.
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