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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911408250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Occlusion (1984); Dizziness (2194)
Event Date 05/17/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr. : the device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause was unable to be determined. (b)(4).
 
Event Description
(b)(6) clinical study. It was reported that coronary artery restenosis occurred. In (b)(6) 2013, the index procedure was performed. The target lesion was a de novo lesion located in the proximal left circumflex (lcx) artery with 95% stenosis and was 6mm long with a reference vessel diameter of 2. 5mm. The target lesion was treated with pre-dilatation and placement of a 2. 50x8mm study stent with 0% residual stenosis. The following day, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, the patient presented to the hospital with symptoms of shortness of breath and dizziness on exertion that would be relieved by rest. The patient underwent a stress study that was abnormal, revealing ischemia in the anterior and inferior walls suggestive of coronary artery disease. The patient was further referred for cardiac catheterization to rule out obstructive coronary artery disease. The following day, coronary angiography was performed. On the same day, the 99% calcified stenosis located in the proximal lcx was treated with balloon angioplasty and placement of a 3. 5x38mm synergy stent. Post procedure, the stenosis was 0% with timi 3 flow. There were no post procedural complications noted. The following day, the event was considered as resolved.
 
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Brand NamePROMUS ELEMENT¿ PLUS
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6623341
MDR Text Key77212746
Report Number2134265-2017-05972
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 05/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2013
Device Model NumberH7493911408250
Device Catalogue Number39114-0825
Device Lot Number0015373800
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 Received05/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2012
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: 06/08/2017 Patient Sequence Number: 1
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