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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 Chest Pain (1776); Ischemia (1942); Myocardial Infarction (1969)
Event Date 01/18/2022
Event Type  Death  
Event Description
It was reported that a patient death occurred. Vascular access was obtained via the radial artery. A percutaneous coronary intervention was performed on a left circumflex (lcx) to a long lesion located in the left anterior descending artery (lad). A 6f guide catheter and a bare metal wire (bmw) were used. A 28 x 2. 75 promus premier select stent was advanced to the lcx for spot stenting. To cover the long lesion in the lad, a 2. 5 x 38 synergy stent was deployed. Following stent deployment, a 2. 5 x 12 non compliant balloon (nc) was advanced to post dilate the lesion. The procedure was completed with these devices. Immediately following the procedure, the patient experienced chest pain, and the vessel was noted to be totally occluded. The patient had experienced a myocardial infarction and ischemia, and the patient passed away.
 
Event Description
It was reported that a patient death occurred. Vascular access was obtained via the radial artery. A percutaneous coronary intervention was performed on a left circumflex (lcx) to a long lesion located in the left anterior descending artery (lad). A 6f guide catheter and a bare metal wire (bmw) were used. A 28 x 2. 75 promus premier select stent was advanced to the lcx for spot stenting. To cover the long lesion in the lad, a 2. 5 x 38 synergy stent was deployed. Following stent deployment, a 2. 5 x 12 non compliant balloon (nc) was advanced to post dilate the lesion. The procedure was completed with these devices. Immediately following the procedure, the patient experienced chest pain, and the vessel was noted to be totally occluded. The patient had experienced a myocardial infarction and ischemia, and the patient passed away.
 
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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 Key13486602
MDR Text Key285316913
Report Number2134265-2022-01303
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10666
Device Catalogue Number10666
Device Lot Number0027365195
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/08/2022 Patient Sequence Number: 1
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