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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 08/09/2018
Event Type  Injury  
Event Description
It was reported that chest pain, st elevation, stent thrombosis, vessel no-flow, and cardiac arrest occurred. The target lesions were located in the proximal left anterior descending artery (p-lad) and proximal right coronary artery (p-rca). Patient was given plavix, aspirin and 10,000 units of heparin during the procedure. Activated clotting time was in the therapeutic range to 78. A 3. 00 x 38 synergy ii stent was successfully implanted in the p-lad and post-dilatation was performed by a 3. 25 x 15 nc emerge balloon catheter. Post-angiogram was performed and results were great. Subsequently, a 3. 0 x 16 synergy ii stent was advanced and implanted in the p-rca. However, within the hour the patient was in the post-recovery unit, patient complained of chest pain and st elevation was noted. Angiogram was performed in the stented area where the stents were implanted and stent thrombosis was noted. The whole vessel had closed and thrombolysis in myocardial infarction(timi) flow was down to zero and patient had arrested code blue. Patient was placed on a non-bsc support device, followed by extracorporeal membrane oxygenation (ecmo). The clot within the stent was removed with an angiojet catheter and was post-dilated. No further complications were reported and the patient's status was finally stable and ambulatory.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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 Key7838572
MDR Text Key118943349
Report Number2134265-2018-60612
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2018 Patient Sequence Number: 1
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