Catalog Number RSINT40038UX |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During a procedure a resolute integrity rx coronary, drug eluting stent was used to treat a lesion in the mid left anterior descending(lad) artery.The device was inspected with no issues noted.Negative prep was not performed.It is reported that an expired stent was implanted in the patient.The product expired on the 25th of may 2019.The patient is alive with no injury.
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Manufacturer Narrative
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Additional information: no intervention as a result of expired product.However it was reported that the patient also received a rsint40038ux also in the mid lad.The patient was noted to have a perforation of the artery after second stent deployment.Two non-medtronic covered stents were placed in the mid lad during this case.Pt remained in the hospital over the weekend and returned to cath lab for repeat angiography.Patient was noted to have inadequate sealing of perforation.A 4.0 non-medtronic stent was placed, patient left lab in stable condition.Patient reported to be doing well post procedure.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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