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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 10667
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that stent damage occurred.Vascular access was obtained via right femoral artery.The 80% stenosed, 28mm x 3mm, concentric, de novo target lesion containing >45 and <90 degrees bend was located in the severely tortuous and mildly calcified left anterior descending artery.Following pre-dilation with a 15 x 2.50 maverick balloon, a 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, during the procedure the stent did not track and resistance was felt.Upon removal it was observed that the stent strut was lifted in the middle portion.The procedure was completed another of the same device.There were no complications reported and the patient was stable.
 
Event Description
It was reported that stent damage occurred.Vascular access was obtained via right femoral artery.The 80% stenosed, 28mm x 3mm, concentric, de novo target lesion containing >45 and <90 degrees bend was located in the severely tortuous and mildly calcified left anterior descending artery.Following pre-dilation with a 15 x 2.50 maverick balloon, a 32 x 3.00 promus premier select drug-eluting stent was advanced for treatment.However, during the procedure the stent did not track and resistance was felt.Upon removal it was observed that the stent strut was lifted in the middle portion.The procedure was completed another of the same device.There were no complications reported and the patient was stable.
 
Manufacturer Narrative
E1 initial reporter first name: (b)(6).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 mid-stent damage.The undamaged crimped stent outer diameter was measured using snap gauge and the result is within maximum 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 damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
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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 Key13076448
MDR Text Key282716387
Report Number2134265-2021-16167
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 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/03/2023
Device Model Number10667
Device Catalogue Number10667
Device Lot Number0026815576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RUNTHROUGH NS WIRE; RUNTHROUGH NS WIRE
Patient Age68 YR
Patient SexMale
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