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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT LONG STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9315
Device Problem Fracture
Event Date 08/03/2018
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. Vascular access was obtained via femoral artery. The 90% stenosed, 38mm x 3. 00mm, concentric, de novo target lesion was located in the mildly calcified left anterior descending artery. After a non-bsc guide wire crossed the lesion and pre-dilatation was performed with a non-bsc balloon catheter, a 3. 00x38mm promus element long stent was advanced for treatment and successfully implanted. On fluoro-shoot, following post-dilatation performed with a non-bsc balloon catheter at 16atm for 20 seconds, the physician observed via stent boost that the mid-segment of stent was fractured. To cover up the stent fracture, a 3. 50x12mm promus element stent was deployed and the procedure was completed. No further 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 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 Key7851107
Report Number2134265-2018-60713
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/22/2019
Device MODEL Number9315
Device Catalogue Number9315
Device LOT Number0020951770
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 Received08/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2017
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: 09/06/2018 Patient Sequence Number: 1
Treatment
BALLOON CATHETERS: SPRINTER AND NC EUHORA
GUIDE WIRE: RUNTHROUGH
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