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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9587
Medical Device Problem Codes Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that shaft break occurred.Following predilitation with a 2.0mmx15mm quantum apex balloon, a 2.25x28mm promus premier stent was advanced for treatment.However, it failed to cross the lesion and the shaft broke.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
PROMUS PREMIER
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8376395
Report Number2134265-2019-01833
Device Sequence Number1599276
Product Code NIQ
UDI-Device Identifier08714729844884
UDI-Public08714729844884
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P110010
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/08/2019
Device Model Number9587
Device Catalogue Number9587
Device Lot Number0021763033
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/06/2019
Initial Report FDA Received Date02/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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