Catalog Number 1074400-12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 04/06/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that immediately after implantation of two rx xience xpedition drug-eluting stents (des) (4.0x33mm and 4.0x12mm) in the right coronary artery (rca) on (b)(6) 2014, the patient began experiencing a constant rash on the back, side, thighs, and underarm areas of the body; the rash is worse than usual every winter.The patient is under the care of an allergist who is treating the rash with a prescription topical ointment, but the rash is only slightly reduced with the ointment.The patient is not experiencing any other adverse effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).There was no reported device malfunction and the product was not returned as it remains implanted in the patient.Subsequent information received confirmed that the patient hypersensitivity was not caused by this device.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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Subsequent to the initial filed medwatch report, additional information received indicated that an allergy test was performed by an allergist using a sample rx xience xpedition drug-eluting stent; the stent was taped to patient arm for 5 days and result for hypersensitivity is negative.The test was repeated with another same type of this stent with the same result.No additional information was provided.
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Search Alerts/Recalls
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