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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911338300
Device Problems Stent (515); Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. (b)(4).

 
Event Description

It was reported that stent damage occurred. The stenosed target lesion was located in the right coronary artery. A 3. 00x38mm promus element ¿ long drug-eluting stent was advanced for treatment. However, it was noted that the stent was lifted. The device was removed and the procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.

 
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Brand NamePROMUS ELEMENT ¿ LONG
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 Key7661283
MDR Text Key113189758
Report Number2134265-2018-06133
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberSIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/02/2019
Device MODEL NumberH7493911338300
Device Catalogue Number39113-3830
Device LOT Number0021222522
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2017
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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