MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number UNK776

Device Problem Occlusion Within Device (1423)

Patient Problems Inflammation (1932); Myocardial Infarction (1969); Reocclusion (1985)

Event Type  Injury  

Manufacturer Narrative

Device is combination product.Sato, takao, et.Al., 'comparison of clinical outcomes of coronary artery stent implantation in patients with end-state chronic kidney disease including hemodialysis for three everolimus eluting (ees) stent designs: bioresorbablye polymer-ees, platinum chromium-ees, ad cobalt chrome-ees', j interven cardiol.2018;31:170-176.Https//doi.Org/10.1111/joic.12469 "effectiveness study of cocr-dp-ees, ptcr-dp-ees and bp-ees in cases with end-stage ckd including dialysis patients", coronary intervention vol.14, no.1, 2018:129-132 device evaluated by mfr: the devices were not returned for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same journal articles as mdr# 2134265-2018-05600.It was reported via journal article that in-stent restenosis and major adverse cardiac event (mace: defined as death, myocardial infarction, repeat percutaneous coronary intervention or coronary artery bypass graft surgery) occurred.Patients presented to the emergency room with suspected acute coronary syndrome.One-hundred-forty-one consecutive stents from three stent groups, including 44 synergy stents, were implanted in 104 patients with chronic kidney disease (ckd).The following outcome variables were compared among the three stent groups after implantation and the 12-month follow-up: target lesion revascularization (tlr), stent thrombosis (st), and mace.Minimal stent diameter and percentage of diameter-stenosis were measured using quantitative coronary angiography.Immediately after implantation, the minimal stent diameter and percentage of diameter-stenosis were equivalent among the three groups.At follow-up, a tendency towards higher tlr was observed for the synergy group compared with the other groups.Late loss in lumen diameter was also significantly greater for the synergy group.There was no incidence of stent thrombosis.It was concluded that synergy might increase the risk of in-stent restenosis in patients with late stage ckd or the need for hemodialysis (hd).It is possible that the biodegradation of the polymer coat of the synergy stent after implantation might cause a greater inflammation than fluoropolymer, such as the inflammation caused by bio­resorbable vascular scaffolds.Several studies have reported that greater inflammation correlates with greater neointimal prolifera­tion in bare metal stents and drug eluting stents (des).In the synergy design, the polymer coat is applied only to the abluminal surface of the stent, unlike the other two des groups included in the study in which the polymer is applied to the entire surface of the stent.It is possible that delamination of abluminal bioabsorbable polymer may occur more easily and severely when it is delivered through a calcified coronary artery, resulting in the attenuation of medicine effectiveness, which likely explains the greater late lumen loss for the synergy stent.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7592642
• MDR Text Key: 110787109
• Report Number: 2134265-2018-05050
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/12/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention