Catalog Number 1012464-23 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Angina (1710); Dyspnea (1816); Stenosis (2263)
|
Event Date 12/01/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(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 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.
|
|
Event Description
|
It was reported that on (b)(6) 2015, the patient underwent a coronary procedure.A 3.5 x 23 mm absorb bioresorbable vascular scaffold (bvs) and a 3.5 x 12 mm absorb bvs were implanted in the distal left anterior descending (lad) artery.On (b)(6) 2017, the patient began to experience exertional angina and dyspnea.A myocardial perfusion scan was performed and there was no inducible ischemia.Coronary angiography was performed on (b)(6) 2018 and noted restenosis in the lad.Medication was administered and percutaneous coronary intervention was performed in the lad, with placement of a stent.No additional information was provided.
|
|
Manufacturer Narrative
|
(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 stenosis as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 the design, manufacture or labeling of the device.
|
|
Search Alerts/Recalls
|