Catalog Number 1012459-28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bradycardia (1751); Dyspnea (1816); Myocardial Infarction (1969)
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Event Date 12/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
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Event Description
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It was reported that on (b)(6) 2013, the patient was admitted to the hospital and a non-st elevated myocardial infarction (nstemi) was diagnosed.On (b)(6) 2013, following pre-dilatation, a 3.0x28mm absorb bioresorbable vascular scaffold (bvs) was implanted in the proximal right coronary artery (rca) lesion and post-dilatation was performed.Reportedly, device use was successful.On (b)(6) 2017, the patient expressed experiencing difficulty breathing and was admitted to the hospital for symptoms of interstitial pneumonia.During this hospitalization, a decrease in hemoglobin value of 5.2 was noted, therefore, aspirin was discontinued.The patient had become bradycardic and elevated cardiac labs were noted.On (b)(6) 2017, another nstemi was diagnosed and medication was provided as treatment.On (b)(6) 2017, electrocardiogram showed the decrease in the st segment was alleviated.Coronary angiography was not performed.Per physician, as the responsible lesion for the myocardial infarction was not identified, it is unknown if the event is related to the device.There was no additional information provided regarding this issue.
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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 effect of myocardial infarction, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu), is a known adverse event 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 effect 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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