Catalog Number UNK ABSORB |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Ischemia (1942); Myocardial Infarction (1969); Perforation of Vessels (2135); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)
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Event Date 09/19/2016 |
Event Type
Injury
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Manufacturer Narrative
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Estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional adverse patient effect of death referenced is filed under a separate medwatch report number.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.Literature attachment.Article title: procedural and long-term outcomes of bioresorbable scaffolds versus drug-eluting stents in chronic total occlusions the bonito registry (bioresorbable scaffolds versus drug-eluting stents in chronic total occlusions).
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Event Description
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It was reported in a research article that absorb bioresorbable scaffolds (brs) may be related to death, target vessel failure, scaffold thrombosis, myocardial infarction, revascularization, hospitalization, perforation with intervention, tamponade with pericardiocentesis, and femoral hematoma.Additional information can be found in the attached article "procedural and long-term outcomes of bioresorbable scaffolds versus drug-eluting stents in chronic total occlusions".
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Manufacturer Narrative
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D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Product performance engineering reviewed the incident information; however, 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 and complaint history could not be conducted because the part and lot number were not provided.The reported patient effects of myocardial infarction, cardiac tamponade, ischemia, perforation and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Search Alerts/Recalls
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