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

Model Number UNK717

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Dyspnea (1816); Reocclusion (1985)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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 case as mdr id 2134265-2018-02388 and 2134265-2018-02390.(b)(4) clinical study.It was reported that restenosis occurred.In (b)(6) 2013, the patient was presented due to myocardial infarction (mi) and unstable angina, and was referred for cardiac catheterization.The index procedure was performed on the same day.Target lesion was a de novo and culprit lesion for st-elevation myocardial infarction located in the mid right coronary artery (rca) with 100% stenosis and was 20 mm long with a reference vessel diameter of 3.5 mm.The lesion was treated with thrombectomy, pre-dilatation and placement of a 3.50x24mm promus element¿ plus stent, with 10% residual stenosis.Five days after, the patient discharged on aspirin and prasugrel.In (b)(6) 2015, the patient presented with apical ischemia.A 4.00 x 20 mm promus element¿ plus stent was implanted in the mid rca and a 4.00 x 32 mm promus element¿ plus stent was implanted in the distal rca.In (b)(6) 2017, the patient presented with the complaints of chest pain and exertional dyspnea and was referred for cardiac catheterization which revealed 60% restenosis of mid rca and moderate rca stenosis.On the same day, the patient underwent fluoroscopy which demonstrated normal cardiac silhouette with visible coronary calcification and visible stent in rca.Subsequently, the patient was recommended for coronary artery bypass graft (cabg).In (b)(6) 2017, the patient presented for planned cabg and the patient was hospitalized on the same day.The patient underwent cabg including reverse saphenous vein graft to distal rca.On the same day, the patient underwent aortic valve replacement.Eleven days later, the events were considered resolved and the patient was discharged on the same day.

• Brand Name: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7374256
• MDR Text Key: 103585498
• Report Number: 2134265-2018-02389
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2018

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: UNK717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/27/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR