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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 05/27/2020
Event Type  Death  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that cardiac arrest and death occurred.The patient presented with chest pain.Vascular access was obtained via the femoral artery.The 80% stenosed, 3.0 x 55 mm, target lesion was located in the non-tortuous and non-calcified left anterior descending (lad), left main coronary (lm) and left circumflex (lcx) arteries.The physician predilated the lad and deployed the 3 x 38 promus premier select drug-eluting stent (des) in the distal portion of the lad.The 3.5 x 20 promus premier select des was deployed in the proximal portion of the lad and lm.The 3.5 x 24 promus premier select des was deployed in the lcx.During the procedure the patient went into sudden cardiac arrest.The patient died in the critical care unit approximately two hours later.The reason for death is unknown by the physician.
 
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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 Key10184996
MDR Text Key196112259
Report Number2134265-2020-08149
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
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/12/2021
Device Model Number10668
Device Catalogue Number10668
Device Lot Number0023801031
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2020
Initial Date FDA Received06/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
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;
Patient Age57 YR
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