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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT LONG STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT LONG STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9315
Device Problem Obstruction of Flow (2423)
Patient Problems Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 01/30/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
(b)(6) clinical study. It was reported that stent thrombosis and st segment elevation myocardial infarction (stemi) occurred. In (b)(6) 2014, the patient was referred for cardiac catheterization and the index procedure was performed on the same day. The target lesion was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 38mm long with a reference vessel diameter of 4. 00mm. The lesion was treated with direct placement of a 4. 00x38mm promus element long drug-eluting stent. Following post dilatation, the residual stenosis was 3%. An additional 2. 5x33mm non-bsc stent was implanted to treat the lesion. Three days after the procedure, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, 833 days post index procedure, the patient was diagnosed with stent thrombosis lead to acute stemi and on the same day, the patient was hospitalized for further evaluation. In (b)(6) 2017, 841 days post index procedure, the patient was referred for coronary angiograph which revealed stent thrombosis from the proximal lad (which had previously placed study device) to mid lad which was treated with percutaneous coronary intervention to mid lad. Following intervention, % residual stenosis was unknown. On the next day, the event was considered to be recovered/ resolved and the patient was discharged.
 
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Brand NamePROMUS ELEMENT LONG
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8760374
MDR Text Key150018048
Report Number2134265-2019-07607
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/21/2015
Device Model Number9315
Device Catalogue Number9315
Device Lot Number0017008295
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 Received06/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2014
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: 07/03/2019 Patient Sequence Number: 1
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