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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 9394
Device Problem Fracture
Event Date 10/19/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent damage occurred. Vascular access was obtained via the right femoral artery. The chronic total occlusion target lesion with reference vessel diameter of 2. 5-3. 00mm was located in the severely calcified and non tortuous right coronary artery. A 2. 75x38mm promus element plus drug-eluting stent was advanced for treatment. However, the device was fractured when deploying it in the vessel. The device was completely removed without any medical interventions. No patient serious injury or adverse event were reported and the patient 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 Key8143857
Report Number2134265-2018-63197
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/10/2019
Device MODEL Number9394
Device Catalogue Number9394
Device LOT Number0020878637
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/03/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2017
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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