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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493952812220
Medical Device Problem Code Bent (1059)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/25/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
 
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.A 2.25x12mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.The device was removed from the patient and it was noted that a stent strut was lifted up.No patient complications were reported and the patient's status was stable and good.
 
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Brand Name
PROMUS PREMIER¿
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key7059457
Report Number2134265-2017-11691
Device Sequence Number1423468
Product Code NIQ
UDI-Device Identifier08714729844648
UDI-Public08714729844648
Combination Product (Y/N)N
Initial Reporter StateWI
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 Health Professional
Type of Report Initial
Report Date (Section B) 11/09/2017
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 Date01/28/2019
Device Model NumberH7493952812220
Device Catalogue Number39528-1222
Device Lot Number0021008133
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/09/2017
Initial Report FDA Received Date11/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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