Catalog Number 1012464-18 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problems
Angina (1710); Thrombosis (2100); Stenosis (2263)
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Event Date 06/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the procedure on (b)(6) 2016 was to treat a heavily calcified lesion in the distal right coronary artery (rca).The patient presented with st elevated myocardial infarction (stemi).Pre-dilatation was performed with a 3.0 x 12 mm non-compliant balloon.A 3.5 x 18 mm absorb scaffold was implanted and post-dilated with a 4.0 x 15 non-compliant balloon.Final angiographic residual stenosis was less than 10%.On (b)(6) 2017, the patient returned with mild chest pain.The patient had stopped their dual antiplatelet drug therapy (dapt) 48 hours prior.Optical coherence tomography (oct) was performed which identified thrombosis at the proximal end of the scaffold, which appeared under-expanded.Restenosis was observed the length of the scaffold.There were malapposed struts at the distal end of the scaffold.A 3.5 x 38 mm non-abbott drug eluting stent (des) was implanted and post-dilated at high pressure.Oct was performed which showed good apposition of the des, but also showed that some struts appeared to have been sheered off and were now located in the distal rca.The patient is asymptomatic.No additional intervention was performed; however, the decision was made to keep the patient on long term dapt.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Correction: patient code (b)(4) was removed.The product was not returned as the scaffold remains in the patient.Cine films and optical coherence tomography (oct) were received and reviewed by an abbott vascular physician.The reviewer concluded the following: there was satisfactory initial index implantation of the absorb scaffold with adequate size device and adequate size post-dilatation balloon.The restenosis approximately 9 months post-implant is a combination of under-expanded scaffold and neointimal hyperplasia, but is focal and flow was well-preserved with no thrombosis.The restenosis was successfully treated with metallic stents.Oct images show the restenosis and intra-luminal disrupted struts distal to the metallic stents after they were placed for the restenosis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effects of angina and restenosis, 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.The investigation determined the reported difficulties and patient effects appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Event Description
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A cine of the procedures was returned and reviewed by an abbott vascular physician.The reviewer confirmed restenosis; however, there was no evidence of thrombosis.
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Search Alerts/Recalls
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