Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 10667
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 44mm x 3.00 mm, de novo target lesion was located in the mildly tortuous and moderately calcified right coronary artery.Following pre-dilation, a 3.00 x 48mm synergy drug-eluting stent (des) and a 32 x 3.00mm promus premier select des were advanced for treatment.However, both devices failed to cross the lesion and the stent struts got damaged.Both devices were removed and the procedure was successfully completed with a 2.50x24mm and 3.00x24mm promus premier select des.No patient complications were reported and the patient status was stable.
 
Event Description
It was reported that stent damage occurred.Vascular access was obtained via the femoral artery.The 90% stenosed, 44mm x 3.00 mm, de novo target lesion was located in the mildly tortuous and moderately calcified right coronary artery.Following pre-dilation, a 3.00 x 48mm synergy drug-eluting stent (des) and a 32 x 3.00mm promus premier select des were advanced for treatment.However, both devices failed to cross the lesion and the stent struts got damaged.Both devices were removed and the procedure was successfully completed with a 2.50x24mm and 3.00x24mm promus premier select des.No patient complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: promus premier select ous mr 32 x 3.00mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with the proximal struts misaligned.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured using snap gauge within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13120260
MDR Text Key283151235
Report Number2134265-2021-16355
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 Physician
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/29/2023
Device Model Number10667
Device Catalogue Number10667
Device Lot Number0027666162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
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 Age52 YR
Patient SexMale
-
-