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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Cardiomyopathy (1764); Reocclusion (1985)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) study.It was reported that in-stent restenosis and angina occurred.In (b)(6) 2014, the clinical assessment indicated that the patient's qualifying conditions were: aortic valve area of 0.89cm^2 with a 21mm annulus diameter.The mean aortic pressure gradient was 35 mmhg and the left ventricular ejection fraction was 43%.Mild aortic regurgitation was noted.In (b)(6) 2014, the index procedure was performed.Heparin or other anticoagulant was given prior to procedure.A 2.5x38mm promus element plus stent was implanted in the proximal to mid left anterior descending artery (lad).On the next day, the patient was discharged on clopidogrel and warfarin.In (b)(6) 2016, the patient presented with angina and a stress test was performed.Stress test showed left ventricular enlargement, significant evidence of ischemia involving large volume of myocardium inferolaterally, abnormal wall motion, hence cardiac catheterization was performed and revealed high-grade in-stent restenosis in the proximal position and severe de novo lesion distal to the stented segment.On the following day, a non-bsc stent was placed in the proximal lad covering the area of stent stenosis and another 2.5 x 18 mm non-bsc drug-eluting stent in mid to distal lad along with an overlapping 2.25x18 non-bsc stent in distal lad.Post-procedure final angiogram showed no evidence of perforation or dissection with residual stenosis of 0 % and timi 3 flow.The patient was recommended to for dual antiplatelet therapy with aspirin and plavix.The event was considered to be 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: 6258040
• MDR Text Key: 64996655
• Report Number: 2134265-2016-12599
• 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: 12/22/2016

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: 12/22/2016
• Initial Date FDA Received: 01/17/2017
• 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
• Patient Age: 90 YR