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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 10663
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that shaft break occurred.The target lesion was located in right coronary artery.After the non-boston scientific (bsc) guide catheter was hooked up and non-bsc wire crossed the lesion, pre-dilation was performed with 2.5mm balloon catheter.A 16 x 4.00 promus premier select drug-eluting stent was advanced for treatment.However, during the procedure while advancing further, the hypo tube was broken.The device was then removed, and the procedure was completed with another 4.00 x 20 promus premier select stent.There were no patient complications reported.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in right coronary artery.After the non-boston scientific (bsc) guide catheter was hooked up and non-bsc wire crossed the lesion, pre-dilation was performed with 2.5mm balloon catheter.A 16 x 4.00 promus premier select drug-eluting stent was advanced for treatment.However, during the procedure while advancing further, the hypo tube was broken.The device was then removed, and the procedure was completed with another 4.00 x 20 promus premier select stent.There were no patient complications reported.
 
Manufacturer Narrative
E1- initial reporter address 1: (b)(6).Device evaluated by manufacturer: a promus premier 16/4.00mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.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 a shaft break 19.5cm distal to the distal end of the strain relief and 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 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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16063289
MDR Text Key308024556
Report Number2124215-2022-55351
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 03/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2023
Device Model Number10663
Device Catalogue Number10663
Device Lot Number0027735471
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2021
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
GUIDE CATHETER USED: JR; GUIDE CATHETER USED: JR
Patient SexMale
Patient RaceAsian
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