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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 H7493952816400
Device Problems Stent (515); Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device is a combination product. (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 from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that the stent damage occurred. The target lesion was located in a coronary vessel. A 4. 00x16mm promus premier¿ drug-eluting stent was advanced to treat the target lesion. However, the device was unable to cross and the stent raised off the balloon. No patient complications were reported.

 
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Brand NamePROMUS PREMIER¿
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7662433
MDR Text Key113170647
Report Number2134265-2018-06021
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/08/2019
Device MODEL NumberH7493952816400
Device Catalogue Number39528-1640
Device LOT Number0021754521
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/09/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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