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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9388
Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2019
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product.

 
Event Description

It was reported that a stent damage occurred. A 2. 75x24mm promus element plus drug-eluting stent was selected for use. However, the device failed to advanced into the wire and the stent struts were distorted and disrupted. No patient serious injury or adverse event were reported and the patient's status was stable.

 
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Brand NamePROMUS ELEMENT PLUS
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8340046
MDR Text Key136164570
Report Number2134265-2019-01291
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeEG
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 04/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/02/2020
Device MODEL Number9388
Device Catalogue Number9388
Device LOT Number22104601
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated By Manufacturer? Yes
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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