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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 9552
Device Problem Fracture
Event Date 01/10/2020
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. Vascular access was obtained via the right radial artery (lad). The 80% stenosed, 3. 5x26mm, concentric, de novo target lesion was located in the non-tortuous and non-calcified left anterior descending artery. The patients ejection fraction was 63%. After a non-bsc guide catheter and a non-bsc guide wire were crossed the lesion, a 28 x 3. 50mm promus premier drug-eluting stent was deployed in the lad. However, angiography revealed type 3 stent fracture. Another 3. 5x24mm promus premier was used to cover the fractured stent and the procedure completed. No patient complications were reported and the patient's status was stable.

 
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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 CORPORATION
ballybrit business park
galway
EI 
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9648332
Report Number2134265-2020-00704
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9552
Device Catalogue Number9552
Device LOT Number0023378379
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/12/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/30/2020 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: 3.5 XB 6F
GUIDEWIRE: BMW
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