MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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

Patient Problems Myocardial Infarction (1969); Obstruction/Occlusion (2422)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

(b)(6).It was reported that abrupt closure and myocardial infarction occurred.On (b)(6) 2021, the subject was enrolled in the study and the index procedure was performed.The 85% stenosed, 4.00 x 20mm, target lesion was located in the proximal left circumflex (lcx).The lesion was treated with predilatation and placement of a 3.50 mm x 32 mm study stent.Post dilation was performed using a 5 mm x 12 mm nc emerge balloon with residual stenosis of 0%.Post procedure, loss of the obtuse marginal (om) and atrioventricular (av) groove circumflex with abrupt closure of the posterior descending artery (pda) was noted resulting in inferior st elevation myocardial infarction (mi) with timi flow of 3.No perforation and thrombus were noted.Multiple guide wires failed before one was able to pass into the av groove.Two emerge mr balloons, 2.0 mm x 12 mm and 1.2 mm x 20 mm, were unable to pass into the av groove.It was determined after a lengthy attempt to end the procedure since the proximal portion of the circumflex was revascularized.Two days later the subject was brought back for a physiology fractional flow reserve (ffr) test of the left anterior descending artery (lad), which resulted in a negative value.The subject was discharged.On (b)(6) 2021, the subject visited the hospital with symptoms related to cardiac arrest and was hospitalized on the same day.The subject underwent diagnostic test of echocardiogram (ecg) which revealed: atrial fibrillation with ventricular tachycardia, age indeterminate un-sustained anteroseptal infarct.Repeat ecg performed revealed: atrial fibrillation with paired ventricular premature complexes and age indeterminate anterior infarct.Follow up ecg performed additionally revealed: atrial fibrillation with ventricular bigeminy.On (b)(6) 2021, ecg performed revealed: atrial flutter with age indeterminate probable anterior infarct and the subject was diagnosed with new cardiomyopathy, inferior wall mi and ventricular tachycardia.On the same day, subject underwent right heart catherization, coronary angiography and intra-aortic balloon pump (iabp) placement.Post operative diagnostic results revealed: elevated left and right heart filling pressures, moderate pulmonary hypertension, low cardiac output/ index and iabp sewed in right common femoral artery for cardiogenic shock.On (b)(6) 2021, the subject expired due to cardiac arrest with pulseless electrical activity (pea).An autopsy was not performed and a death certificate is not available.It was noted this was out of proportion response caused by abrupt closure of a small side branch, which may or may not have been a major contributing factor to cardiac arrest.The study stent was not believed to have high correlation to the patient death.It was suspected that co morbidities more relevant to cardiac arrest was sustained ventricular tachycardia.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12516029
• MDR Text Key: 272889358
• Report Number: 2134265-2021-11968
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• 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: 62 YR