Catalog Number 1012463-28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Stenosis (2263)
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Event Date 10/05/2016 |
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 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.The two additional absorb devices referenced in describe event or problem are filed under separate manufacturer report numbers.
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Event Description
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It was reported that on (b)(6) 2014, a 2.5 x 12 mm, 3.0 x 23 mm, and a 3.5 x 28 mm absorb bioresorbable vascular scaffold (bvs)s were successfully implanted in the proximal circumflex (cx) coronary artery lesion.On (b)(6) 2015, the patient was admitted for a staged, planned procedure to the left anterior descending (lad) coronary artery.Unspecified stents were implanted.On (b)(6) 2016, the patient was admitted to the hospital due to chest tightness, diagnosed as stable angina.A coronary angiogram was performed.The previously implanted lad stents reportedly looked good with mid disease beyond the stented segment in the lad.The cx had stenosis within the scaffold segment.On ivus, the stenosis could not be differentiated between scaffold sites.There was some positive (clinically positive) vessel remodeling in the proximal scaffold segment where the scaffold had expanded.On the contrary however, there was some negative (clinically negative) vessel remodeling in a short scaffold segment, with a loss of radial strength, and low attenuation intimal thickening, with some neo-atherosclerosis associated with potential neo-vessel formation.Per physician, another revascularization was not required and was not performed.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 effects of angina and restenosis, 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 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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Subsequent to the previous report submitted, additional information indicates that the absorb bioresorbable vascular scaffold implanted in the proximal circumflex coronary artery lesion was a 3.0x28mm (not 3.0x23mm as previously reported).
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Manufacturer Narrative
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(b)(4).
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Event Description
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Subsequent to the previous medwatch report filed, the additional information was received: on (b)(6) 2016, restenosis was located at the 2.5x12 and 3.0x28 scaffold sites.Prolonged dual antiplatelet therapy (dapt) medications were prescribed due to the event.There was no stenosis in the 3.5x28 scaffold.
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Search Alerts/Recalls
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