MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Reocclusion (1985); Tachycardia (2095); Cardiac Tamponade (2226); Pseudoaneurysm (2605)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Event date was not provided so the date that the articles was published was been used as the event date.N.Pandey et al."right coronary artery pseudoaneurysm post everolimus eluting stent implantation causing tamponade" bmj case rep 2018.Doi: 10.1136/bcr-2018-227714.Initial reporter facility name: department of cardiovascular radiology and endovascular interventions, all india institute of medical sciences.Device is combination product.

Event Description

It was reported via journal article that the patient experienced a pseudoaneurysm.This patient with triple vascular artery disease underwent percutaneous coronary intervention.The right coronary artery (rca) was treated with two platinum chromium everolimus- eluting (promus premier) stents a 3.5x16 mm in proximal rca and 3.5x38 mm in mid-to-distal rca, respectively, with stenting of the left anterior descending (lad) artery and first obtuse marginal artery (om1) as well.The patient was readmitted a month later with chest pain and dyspnea on exertion.On examination, the patient had tachycardia, elevated jugular venous pressures and mild hypotension.A catheter angiogram revealed a small pseudoaneurysm arising from the rca with occluded mid rca stent.In view of disproportionately severe symptoms compared with the size of the pseudoaneurysm and to delineate the anatomy of the pseudoaneurysm for planning management, a coronary ct angiography (cta) was advised.The cta revealed patent proximal rca stent, with near occlusion of the rca just proximal to the mid rca stent.A small pseudoaneurysm was seen arising at the level of proximal 1/3rd of the second stent, with a large surrounding hematoma in the atrioventricular groove.The stent showed in-stent total occlusion, with reformation of distal rca and a good-sized posterior descending artery.Mass effect was noted on the right atrium (ra) and right ventricle with dilated ra and inferior vena cava with flattening of the interventricular septum, indicating localized tamponade.The lad and om1 stents were patent.The patient underwent surgery with repair of the rca pseudoaneurysm using direct pledgeted sutures and had an uneventful post-operative course.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8163858
• MDR Text Key: 130317260
• Report Number: 2134265-2018-63918
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR