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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 9583
Medical Device Problem Code Failure to Advance (2524)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 11/14/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(6).
 
Event or Problem Description
It was reported that artery dissection occurred.The target lesion was located in the left anterior descending artery.A 2.25x12mm promus premier drug-eluting stent was used for treatment, but failed to cross the lesion.When the physician tried to remove the device the artery a non flow limiting dissection occurred.The physician used a different device to overlap the dissected artery.No serious injury and no further 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 Key8157611
Report Number2134265-2018-63745
Device Sequence Number13527013
Product Code NIQ
UDI-Device Identifier08714729844648
UDI-Public08714729844648
Combination Product (Y/N)N
Initial Reporter StateTX
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/20/2019
Device Model Number9583
Device Catalogue Number9583
Device Lot Number0022211916
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/21/2018
Initial Report FDA Received Date12/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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