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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 10664
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Vascular Dissection (3160)
Event Date 12/28/2021
Event Type  Injury  
Event Description
It was reported that a dissection occurred. The target lesion was located in a 100% occluded moderately tortuous right coronary artery (rca). Following predilatation, a 24 x 4. 00 promus premier select was deployed in the rca. Following deployment, stent strut damage was noted from the mid to distal edge of the drug eluting stent. Another 24 x 4. 00 promus premier select was deployed to cover the previously placed damaged stent. Following the second stent deployment, a distal edge dissection was noted. A 3. 00 x 20 promus premier select was deployed to cover the dissection and complete the procedure. No further patient complications resulted in relation to this event.
 
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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 Key13237944
MDR Text Key283753904
Report Number2134265-2021-16685
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,Followup,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/10/2022
Device Model Number10664
Device Catalogue Number10664
Device Lot Number0025612431
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2022 Patient Sequence Number: 1
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