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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 10666
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Obstruction/Occlusion (2422); Electric Shock (2554)
Event Date 10/24/2020
Event Type  Death  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that obstruction and patient death occurred.The patient presented to the hospital with chest pain.Vascular access was obtained via the femoral artery.The 80% stenosed, 50 x 2.50mm target lesion was located in the moderately calcified left anterior descending artery (lad).Following predilitation, a 28 x 2.50 promus premier select device was deployed in the proximal mid lad.During the procedure, the patient had slow flow and no reflow in the lad.The patient went into ventricular tachycardia and ventricular fibrillation (vt/vf).The patient was given medications but died in the coronary care unit (ccu) in half an hour.
 
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that obstruction and patient death occurred.The patient presented to the hospital with chest pain.Vascular access was obtained via the femoral artery.The 80% stenosed, 50 x 2.50mm target lesion was located in the moderately calcified left anterior descending artery (lad).Following predilatation, a 28 x 2.50 promus premier select device was deployed in the proximal mid lad.During the procedure, the patient had slow flow and no reflow in the lad.The patient went into ventricular tachycardia and ventricular fibrillation (vt/vf).The patient was given medications but died in the coronary care unit (ccu) in half an hour.It was later reported that the patient was experiencing chest pain a few days prior to admission in the hospital for the diagnosis of further treatment.Angiography revealed that the lad had significant disease n the proximal mid segment.After deployment of the stent, the artery had slow flow no reflow.During the management of the event, the patient had vt/vf.Shock was given to the patient with defibrillator to bring the patient back from vt/vf, but the condition of the patient was not improved, and with cpr, the patient was transferred to the intensive care unit (icu).The timeframe between the discovery of the issue to the corrective action and death was approximately one hour.The cause of death was due to slow flow in the artery followed by vt/vf.An autopsy was not performed.
 
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Brand Name
PROMUS PREMIER SELECT
Type of Device
STENT, 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 Key10780453
MDR Text Key214421557
Report Number2134265-2020-15227
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/19/2022
Device Model Number10666
Device Catalogue Number10666
Device Lot Number0025142050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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