MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING

Model Number UNK634

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985); ST Segment Elevation (2059); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Literature citation: hamshere, stephen et al.(2018).Randomised trial of the comparison of drug-eluting stents in patients with diabetes: oct des trial.Open heart 2018;5:e000705.Doi: 10.1136/openhrt-2017-000705.Device evaluated by mfr: the device was 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 literature article as 2134265-2018-05337.Reported vial journal article it was reported that myocardial infarction, thrombosis and in-stent restenosis (isr) occurred.The aim of the study was to assess the degree of neointimal stent coverage in second generation drug eluting stents (des) in a diabetic population and to assess the clinical and angiographic outcomes of second generation des.Patients were randomized to receive either a promus element drug eluting stent or another manufacturers drug eluting stent.Intracoronary oct (optical coherence tomography) was performed 6 months post-procedure.Significant isr by oct was defined by >50% of the diameter stenosis in the stented region.Analysis included stent mal-apposition defined as struts with detachment from the vessel.At six months post procedure oct was performed and significant isr was seen in 15% (9) patients with no significant difference seen in rates of significant isr or symptoms between the two stent types.The overall incidence of mace rates was 8.2% with the cause being non-st elevation myocardial infarction requiring reintervention.One incidence was st-elevation myocardial infarction secondary to incomplete stent expansion that resulted in stent thrombosis 3 days post stent deployment.Mal-apposed stent struts were observed in both stent types.

• Brand Name: PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 7590802
• MDR Text Key: 110721928
• Report Number: 2134265-2018-04979
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: UNK634
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention