Catalog Number 1012462-28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Angina (1710)
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Event Date 06/02/2016 |
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 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) 2014, the patient underwent a coronary procedure, with implantation of a 2.5 x 28 mm absorb bioresorbable vascular scaffold (bvs) and a 3.5 x 28 mm absorb bvs in the proximal left anterior descending (lad) artery.On (b)(6) 2016, the patient was re-hospitalized with troponin-negative non-cardiac chest pain.Medication was administered on (b)(6) 2016.The patient condition resolved and the patient was discharged on (b)(6) 2016.The patient was referred for outpatient stress echocardiogram; however, the echo window was poor and the physician was unable to see the left ventricle segments.The patient was then referred for cardiac magnetic resonance imaging (mr), which noted normal biventricular size and function and no regional wall motion abnormality.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Subsequent to the initial 30-day medwatch report, it was noted that this event occurred prior to absorb bioresorbable vascular scaffold (bvs) gt1 approval.At the time of the event, this device was not the same or similar to an approved product; however, this event was filed; therefore, it remains reportable.No investigation is required.
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Event Description
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Subsequent to the initial 30-day medwatch report, it was noted that this event occurred prior to absorb bioresorbable vascular scaffold (bvs) gt1 approval.At the time of the event, this device was not the same or similar to an approved product; however, this event was filed; therefore, it remains reportable.No additional information was provided.
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Search Alerts/Recalls
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