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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 H7493952824220
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 10/05/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event or Problem Description
It was reported that vessel dissection occurred.The target lesion was located in a coronary artery.A 2.25x24mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.However, a vessel dissection was noted.The procedure was completed using a different device.No further patient complications were reported.
 
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Brand Name
PROMUS PREMIER¿
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key6976473
Report Number2134265-2017-10495
Device Sequence Number1156889
Product Code NIQ
UDI-Device Identifier08714729844822
UDI-Public08714729844822
Combination Product (Y/N)N
Initial Reporter StateCA
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) 10/06/2017
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 Date06/26/2018
Device Model NumberH7493952824220
Device Catalogue Number39528-2422
Device Lot Number0020125004
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/06/2017
Initial Report FDA Received Date10/25/2017
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 Other;
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