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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 H7493911408250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Nausea (1970); ST Segment Elevation (2059); Vomiting (2144); Chest Tightness/Pressure (2463)
Event Date 10/06/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr. : the complaint device was not returned for analysis. 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
Same case as mdr id: 2134265-2017-117964. (b)(6) clinical study. It was reported that myocardial infarction (mi) occurred. In (b)(6) 2012, the patient presented due to mi and unstable angina and was referred for cardiac catheterization. Subsequently, index procedure was performed on the same day. Target lesion #1 was a de novo lesion located in the mid left anterior descending artery with 99% stenosis and was 8 mm long with a reference vessel diameter of 2. 55 mm. Target lesion #1 was treated with pre-dilatation and placement of 2. 50x12mm and 2. 50x8. 00mm promus element¿ plus stents in overlapping manner to cover the entire lesion. Following post-dilatation, residual stenosis was 0%. Target lesion #2 was located in the proximal right coronary artery with 80% stenosis and was 5 mm long with a reference vessel diameter of 3. 00 mm. Target lesion #2 was treated with direct placement of 3. 00 x 12. 00 mm promus element¿ plus stent with 0% residual stenosis. The following day, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, the patient was found down at her home. It was reported that the patient was trying to look for her stuff while seated at the floor, but later could not get up. The reported that she also had complaints of back pain since her last fall. It was also reported that the patient intermittently experienced nausea and vomiting for 2 weeks. On the same day, the patient was presented to the emergency department (ed). At the ed, the patient also developed burning type chest discomfort on her left side, which was not radiating. Electrocardiogram showed anterioseptal st elevation myocardial infarction. However, the subject declined any interventions, hence the patient was admitted to the hospital on the same day for further care. The patient received medication in response to the event. During the hospital course, an echocardiogram revealed a left ventricular ejection fraction of 25%, grade 2 diastolic dysfunction and the physician felt that it was a poor prognosis. However, the patient chose not to undergo any intervention (cardiac catheterization). The patient had requested code status to be do not resuscitate (dnr/ dni). Four days later, outcome of the event was considered as resolved. On the same day the patient was discharged from the hospital to a hospice care.
 
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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 - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7081908
MDR Text Key93681281
Report Number2134265-2017-11796
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 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2017
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 Number15373800
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 Received11/10/2017
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: 12/05/2017 Patient Sequence Number: 1
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