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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911412250
Device Problem Occlusion Within Device (1423)
Patient Problems Chest Pain (1776); Reocclusion (1985); Dizziness (2194)
Event Date 10/05/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that in (b)(6) 2017, core-lab angiography of mid left anterior descending artery revealed, absence of thrombus as well as aneurysm and absence of in-stent restenosis were noted.
 
Manufacturer Narrative
Device is a combination product. The device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling. (b)(4).
 
Event Description
(b)(4) clinical study. It was reported that chest pain and in-stent restenosis occurred. In (b)(6) 2013, the patient was noted to have silent ischemia, abnormal stress test or imaging stress test indicative of ischemia. Subsequently, coronary angiography and index procedure were performed. The target lesion was located in the mid left anterior descending (lad) artery with 65% stenosis and was 10mm long with a reference vessel diameter of 2. 5mm. The lesion was treated with pre-dilatation and placement of a 2. 50x12mm 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 with the 5 days history of chest pain and dizziness. Subsequently, the patient was hospitalized on the same day for further evaluation. On the following day, coronary angiography was performed and revealed 85% ostial stenosis; 25% in-stent restenosis (isr) in proximal stent; isr of study stent in mid-lad. On the same day, 85% stenosis in the ostial proximal lad was treated with pre-dilatation and placement of 3. 0mmx8mm promus premier stent with 0% residual stenosis. On the following day, the patient was discharged on dual antiplatelet therapy in stable condition.
 
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Brand NamePROMUS ELEMENT¿ PLUS
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 Key7068138
MDR Text Key263075902
Report Number2134265-2017-11606
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,Followup
Report Date 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/09/2013
Device Model NumberH7493911412250
Device Catalogue Number39114-1225
Device Lot Number15609951
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 Received06/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2012
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: 11/29/2017 Patient Sequence Number: 1
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