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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 Problems Positioning Problem (3009); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2024
Event Type  malfunction  
Event Description
It was reported that stent placement and balloon deflation issues occurred.A 12 x 3.00 promus elite stent balloon expandable was selected for treatment.During the procedure, the promus elite stent could not be correctly placed and subsequently could not be deflated.The procedure was completed with a different device and no patient complications were reported.
 
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Brand Name
PROMUS ELITE
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18932825
MDR Text Key338318369
Report Number2124215-2024-15537
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10671
Device Catalogue Number10671
Device Lot Number0031992698
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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