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

Model Number H7493911412350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Fatigue (1849)

Event Date 05/22/2017

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 the patient experienced dyspnea and atrial fibrillation.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was myocardial infarction (mi) and stable angina.Elevated biomarkers indicated ischemia prior to procedure.Subsequently, index procedure was performed.The target lesion #1 was located in the 1st obtuse marginal (om) with 80% stenosis and was 9mm long with a reference vessel diameter of 3.7mm.The lesion #1 was treated with pre-dilatation and placement of a 3.50x12mm study stent with 0% residual stenosis.The target lesion #2 was located in the distal right coronary artery (rca) with 99% stenosis and was 7mm long with a reference vessel diameter of 3.1mm.The lesion #2 was treated with pre-dilatation and placement of a 3.00x12mm study stent with 0% residual stenosis.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient presented to the hospital due to shortness of breath, worsening dyspnea on exertion, fatigue and chest pain.The patient had an exercise echocardiogram (stress test) which was negative for ischemia with no wall motion abnormalities.Since the patient's symptoms were concerning, the patient was referred for cardiac catheterization.Thirteen days later, the patient was presented to the hospital for an elective coronary artery bypass graft (cabg) and a left atrial appendage ligation.On the same day, the patient underwent coronary artery bypass graft (cabg) procedure from saphenous vein graft (svg) to right posterolateral artery (rpla) and svg to om.Additionally the patient also underwent cabg procedure from left internal mammary artery (lima) to left anterior descending artery (lad), and svg to diagonal.The patient was transferred to the cardiovascular intensive care unit (cvicu) post operation for recovery, acute intensive care unit (icu) and ventilator management.During the course of hospitalization, the patient developed atrial fibrillation with rapid ventricular rate (rvr) and was transferred back to the icu for possible cardioversion.Cardiac electrophysiology was consulted and since the patient was asymptomatic atrial fibrillation was treated medically.The patient was started on amiodarone and lopressor and atrial fibrillation was controlled.Eight days post-procedure, the patient was transferred back to the geriatric psychiatric unit (gpu) in stable condition.The following day the patient underwent successful direct current cardioversion (dccv) x 1 to sinus rhythm (sr) with electrophysiology (ep).Av wires were removed after 24 hours without complications.In (b)(6) 2017, the patient was discharged in stable condition on aspirin, lopressor and statin.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 6649234
• MDR Text Key: 77821994
• Report Number: 2134265-2017-06250
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2013
• Device Model Number: H7493911412350
• Device Catalogue Number: 39114-1235
• Device Lot Number: 15601126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2012
• 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: 65 YR