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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 H7493911412300
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); ST Segment Depression (2487)
Event Date 09/03/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specifications. The most probable root cause is anticipated procedural complication as the reported event is due to a known physiological effect of the procedure noted within the product directions for use (dfu) and/or device labeling. (b)(4).
 
Event Description
(b)(6) clinical study. It was reported that following a coronary artery drug eluting stenting treatment procedure, the patient had myocardial infarction (mi). In (b)(6) 2012, the patient was diagnosed with stable angina (ccs classification: 3) and was referred for cardiac catheterization. The de novo target lesion was located in the proximal right coronary artery (prox rca) with 80% stenosis and was 10 mm long with a reference vessel diameter of 3. 0 mm. The target lesion was treated with direct placement of a 3. 00 x 12 mm promus element plus stent. Following post-dilatation, residual stenosis was 0%. The patient was discharged on aspirin and ticagrelor the next day. In (b)(6) 2017, the patient was presented to emergency department with shortness of breath and chest discomfort and the patient was referred for further evaluation. During the course at emergency department, the patient¿s pain returned. The patient¿s cardiac enzymes were noted to be elevated and the site reported an event of non st-elevation myocardial infarction (nstemi). Baseline enzymes were not withdrawn. Hence, the patient was admitted to the hospital for further diagnosis. During hospitalization the patient¿s shortness of breath worsened and the patient was diagnosed with acute exacerbation of chronic obstructive pulmonary disease (copd), anemia and thrombocytopenia. Further, the patient was referred for cardiac catheterization and possible intervention. Two days later, the 90% stenosis located in distal rca was treated with pre-dilatation and placement of a 2. 75 x 28 mm non-bsc drug-eluting stent. Following post-dilatation, completion angiogram showed excellent results without thrombosis, perforation or dissection. The event was considered resolved and was recommended for cardiac rehabilitation. Two days later, the patient was discharged on aspirin and ticagrelor.
 
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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 Key6930245
MDR Text Key89026842
Report Number2134265-2017-09889
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 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/13/2013
Device Model NumberH7493911412300
Device Catalogue Number39114-1230
Device Lot Number0015337131
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 Received09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2012
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: 10/09/2017 Patient Sequence Number: 1
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