MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ION; CORONARY DRUG-ELUTING STENT

Device Problem Obstruction of Flow (2423)

Patient Problem Reocclusion (1985)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Device is combination product.Event date is unknown and has been estimated.Kajiya, takashi md., et.Al., "in-stent restenosis assessed with frequency domain optical coherence tomography shows smooth coronary arterial healing process in second-generation drug-eluting stents", singapore med j 2019; 60(1): 48-51 https://doi.Org/10.11622/smedj.2018038.

Event Description

It was reported via journal article that in stent restenosis (isr) occurred.First generation drug eluting stents (des), taxus and non-bsc stents, were implanted for 805 lesions from april 2008 to january 2011.Second generation des, promus element and non-bsc stents, were implanted for 1,269 lesions from january 2011 to december 2014.Follow up coronary angiography (cag) was performed at 6-9 months after percutaneous coronary intervention (pci) and the second cag at 18-24 months after pci.All patients had been taking aspirin and clopidogrel for at least one year.Patients who underwent follow-up cag were examined.Isr was defined as lesions of over 50% diameter stenosis at follow-up cag.Frequency domain optical coherence tomography (oct) was performed at the time of revascularisation of isr.Tissue morphology was assessed at minimum lumen area.Oct images of dess at both early, less than or equal to one year, and late, greater than one year) phase follow-up were compared.The incidence of isr among patients for whom second-generation dess were implanted was significantly lower than that for first-generation dess.The study supports previous data that the arterial healing process is smooth and that stent struts are mainly covered with neointima in both early and late phase isr when second-generation dess are used.As a result, stent thrombosis can be expected to be rare in patients with second generation des implantation.Homogeneous tissue morphology was more frequently found for second-generation than first-generation des isr, especially in the late phase.This suggested that neointimal hyperplasia was the main mechanism in second generation des isr, and that the neointima was stabilised, much like in bare metal stent implantation.

• Brand Name: ION
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8456957
• MDR Text Key: 140029045
• Report Number: 2134265-2019-02882
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention