• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10663
Device Problem Activation Failure (3270)
Patient Problem Ischemia (1942)
Event Date 03/29/2022
Event Type  Injury  
Event Description
It was reported that inadequate apposition occurred. The 85% stenosed target lesion was located in the non-tortuous and severely calcified left anterior descending artery. Following predilation with a 2. 00 x 8mm semi compliant balloon, the 2. 50 x 16mm promus premier select drug eluting stent was implanted to treat the target lesion. The stent did not open completely with the stent balloon so an attempt was made to inflate the stent with a 2. 75 x 12mm non compliant balloon at 22 atmospheres. The stent still did not open completely and was not well apposed. The desired timi 3 flow was not achieved and the patient was sent for coronary artery bypass graft surgery for complete revascularization.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14121444
MDR Text Key289422331
Report Number2134265-2022-04166
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,Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10663
Device Catalogue Number10663
Device Lot Number0027864224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2021
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: 04/15/2022 Patient Sequence Number: 1
-
-