Catalog Number EX060603CS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
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Event Date 03/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient or procedural details to bard.
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Event Description
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It was reported that after an unknown period of time post deployment of the stent, the patient experienced pain and swelling of the left leg.Reportedly, the patient would have an allergy to nickel.There was no reported patient injury.
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Manufacturer Narrative
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The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential product and non product related factors which may have caused or contributed to the reported issue have been considered.Allergic reactions may be caused by nickel leaching, however, niti is known as an inert metal composition commonly used in the medical industry.It is unlikely that the patient¿s alleged symptoms (leg pain) would be associated with a nickel allergy; a systemic reaction was not reported.Any concerns regarding the possibility of nickel allergy or other potential complications associated with the stent placement (if any) cannot be evaluated based on the information available and should be discussed directly with the responsible doctor.The patient was recommended to the see the doctor whereupon she confirmed a scheduled appointment.Based on the information available and as a coherence between an allergic reaction of the patient and the implanted nitinol stent could not be verified a definitive root cause for the reported complaint could not be determined.The ifu states that the lifestent vascular stent system is contraindicated for use in patients with a known hypersensitivity to nitinol (nickel, titanium), and tantalum.
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Event Description
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It was reported that after an unknown period of time post deployment of the stent, the patient experienced pain and swelling of the left leg.Reportedly, the patient would have an allergy to nickel.There was no reported patient injury.
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Search Alerts/Recalls
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