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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10671
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that stent profile problem occurred. The 90% stenosed target lesion was located in the middle of left anterior descending artery, with a bend of >45 and <90. A 12 x 2. 75 promus elite drug-eluting stent was advanced for treatment. However, during procedure, it was noted that the stent was seen parked at the target lesion under angio and showed geographical miss after stent was deployed. The device was removed and the procedure was completed with the original device. There were no patient complications and the patient was stable.
 
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Brand NamePROMUS ELITE
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 Key12456325
MDR Text Key270918143
Report Number2134265-2021-11515
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10671
Device Catalogue Number10671
Device Lot Number0026782992
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 Received09/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2021
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: 09/10/2021 Patient Sequence Number: 1
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