Catalog Number UNK ABSORB |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Thrombosis (2100)
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Event Date 04/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.The devices were not returned for evaluation.A review of the lot history records and complaint histories could not be conducted because the part and lot numbers were not provided.The reported patient effects of thrombosis, and myocardial infarction are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu), as known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the reported patient effects could not be determined.The treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents.The other events listed in the article and are filed under other mfr report numbers.
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Event Description
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This report is filed for the serious injuries.It was reported through a research article identifying absorb scaffolds that may be related to the following: cardiac death, thrombosis, myocardial infarction, target lesion re-vascularization, and hospitalization.Additionally, adverse events may be related to malapposition of the scaffold.Specific patient information is documented as unknown.Details are listed in the attached article, titled: "everolimus-eluting bioresorbable scaffoldsversus everolimus-eluting metallic stents.".
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Search Alerts/Recalls
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