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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9305
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 06/12/2020
Event Type  Injury  
Event Description
(b)(6). It was reported that restenosis occurred. On (b)(6) 2014, the mid left anterior descending artery (lad) was treated with a 3. 50 x 16mm promus element stent. On (b)(6) 2020, the subject presented with current ccs class 1 stable angina and the index procedure was performed on the same day. The 99% stenosed target lesion was located in the mid left anterior descending artery (lad) and was 25. 00 mm long, with a reference vessel diameter of 2. 75mm. The lesion was predilated with a 2. 75mm x 10mm balloon. Post predilation, a grade c dissection was noted, however no further intervention was required other than the planned index procedure. Following predilation, the target lesion was treated with the study device, resulting in 25% residual stenosis and timi flow 3. Post dilation was not performed. On (b)(6) 2020, the subject was discharged on aspirin and clopidogrel.
 
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Brand NamePROMUS ELEMENT
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13638566
MDR Text Key286644995
Report Number2134265-2022-02292
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9305
Device Catalogue Number9305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/01/2022 Patient Sequence Number: 1
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