Catalog Number 1234300-23 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis (2100)
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Event Date 11/18/2016 |
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 additional absorb gt1 referenced is being filed under a separate manufacturer report number.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that two absorb gt1 scaffolds were implanted in the proximal left anterior descending artery with moderate calcification.The patient returned 10 days later and scaffold thrombosis was found requiring medical intervention.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 the scaffold remains in the anatomy.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 myocardial infarction and thrombosis, as listed in the absorb gt1 instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, 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 design, manufacture or labeling of the device.
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Event Description
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Updated event description: it was reported that the procedure on (b)(6) 2016 was to treat the proximal to mid left anterior descending artery (lad) with moderate calcification the patient presented with angina and st elevated myocardial infarction (stemi).Pre-dilatation was done with several balloons, reducing the stenosis to less than 40%.Two 3.0 x 23 mm absorb gt1 scaffolds were implanted.The patient returned on 11/18/2016 again with stemi and heavy thrombosis was found in both scaffolds.Two 2.5 x 18 mm absorb gt1 scaffolds were implanted for treatment.It was confirmed that the patient had been compliant with dual antiplatelet drug therapy (dapt).No additional information was provided.
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Search Alerts/Recalls
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