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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number UNK717
Device Problem Occlusion Within Device (1423)
Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Reocclusion (1985); Obstruction/Occlusion (2422)
Event Date 04/18/2015
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. The device was not received for analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-00300. (b)(4) clinical study. It was reported that in-stent restenosis (isr) and non-st segment elevation myocardial infarction (nstemi) occurred. In (b)(6) 2013, index procedure was performed. Target lesion was a de novo lesion located in the mid left anterior descending artery (lad) with 80% stenosis and was 22 mm long with a reference vessel diameter of 2. 75 mm. Target lesion was treated with pre-dilatation and placement of a 2. 50 mm x 16 mm and 2. 50 mm x 8 mm promus element¿ plus drug-eluting stents (des) in overlapping manner. Following post dilatation residual stenosis was 0%. The following day, the patient was discharged on aspirin and prasugrel. In (b)(6) 2015, the patient presented to the emergency department (ed) with the complaint of chest pain. The patient described the pain as a tight sub sternal pressure that radiates to both shoulders with associated shortness of breath. Electrocardiogram (ecg) revealed atrial fibrillation with rapid ventricular response; anterolateral st-t changes are nonspecific. On the same day, cardiac enzymes were noted to be elevated. The elevated level of cardiac enzyme along with ecg changes suggested acute ischemia and the site has reported an event of nstemi. The patient was started on iv heparin and nitroglycerin drip for nstemi and was referred for cardiac catheterization. The next day, a 99% isr of the middle of the stents in the mid portion with a very sluggish flow and a mild 30% stenosis in the mid segment of the 2nd diagonal were noted. The 99% isr located in mid lad was treated with pre-dilatation and placement of 2. 5 mm x 26 mm, 3. 00 mm x 22 mm and 3. 00 mm x 22 mm non-bsc des in overlapping manner with 0% residual stenosis. The following day, the event was considered as resolved and the patient was discharged on aspirin and prasugrel.
 
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Brand NamePROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of DeviceSTENT, 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 Key6278660
MDR Text Key65767431
Report Number2134265-2017-00299
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110010
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 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK717
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 Received01/06/2017
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 Treatment Data
Date Received: 01/26/2017 Patient Sequence Number: 1
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