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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10668
Device Problems Fracture; Difficult to Advance
Event Date 12/10/2019
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. A percutaneous coronary intervention was being performed on a moderately calcified and moderately tortuous lesion in the left anterior descending (lad) coronary artery. The left main coronary artery was engaged with 6f 3. 5 guiding catheter and the lesion was crossed with a wire. The lad was pre dilated with a 2. 5 x 13mm balloon at 16 atmospheres. A 3. 5 x 38mm promus premier select stent was advanced with significant resistance encountered and deployed at 12 atmospheres. Post dilatation was done with a 3. 5 x 12mm balloon at 20atmospheres. Final check confirmed there was timi iii flow with no dissection and a good result. The patient returned complaining of chest discomfort. An angiogram confirmed a stent fracture. A 3. 5 x 12mm promus premier select stent was implanted to obtain revascularization.

 
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Brand NamePROMUS PREMIER SELECT
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 Key9468288
Report Number2134265-2019-15776
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10668
Device Catalogue Number10668
Device LOT Number0023227428
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 Received12/31/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2019
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: 12/13/2019 Patient Sequence Number: 1
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