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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 Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/12/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that stent dislodgment occurred.Vascular access was obtained via the radial artery.The target lesion was located in a moderately tortuous and heavy calcified left circumflex artery.A 3.00x12mm promus premier drug-eluting stent was advanced for treatment.However, the stent came off the balloon and lodged in the arm which was then retrieved by snaring.The procedure was completed with a different stent.There were no patient complications reported and the patient was fine.
 
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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 Key8487155
Report Number2134265-2019-03502
Device Sequence Number1928156
Product Code NIQ
UDI-Device Identifier08714729844679
UDI-Public08714729844679
Combination Product (Y/N)N
Initial Reporter StateTN
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 Physician
Type of Report Initial
Report Date (Section B) 04/05/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date05/04/2020
Device Model Number9583
Device Catalogue Number9583
Device Lot Number0022964500
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/14/2019
Initial Report FDA Received Date04/05/2019
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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