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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9548
Device Problem Fracture
Event Date 01/26/2019
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. Vascular access was obtained in the femoral artery. The 85% stenosed, 3x28mm, concentric target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery. The lesion contained >45 and <90 degrees bend. Following pre-dilation with a 2. 0x20mm balloon, a 12 x 3. 00mm promus premier drug-eluting stent was advanced for treatment. However, the stent was fractured and found hanging in the lumen. The procedure was completed with a different device and no patient complications were reported.

 
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Brand NamePROMUS PREMIER
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 Key8345254
Report Number2134265-2019-01222
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 02/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/29/2019
Device MODEL Number9548
Device Catalogue Number9548
Device LOT Number0021462449
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/29/2017
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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