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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 10668
Device Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that stent fracture and additional intervention occurred.The patient was diagnosed with coronary artery disease (cad).A percutaneous transluminal coronary angioplasty was performed on a de novo lesion in the right coronary artery (rca).A 38 x 3.00 promus premier select stent was deployed in the rca.After deployment, the lesion was post dilated with a 12 x 3.5 nc balloon at 16 atmospheres.After post dilation, while taking orthogonal views of the deployed stent, a stent fracture was observed.A 12 x 3.5 promus premier select was deployed to cover the stent fracture.No further patient complications were reported in relation to this event and the patient was reported to be stable at the end of the procedure and stable following the procedure.
 
Event Description
It was reported that stent fracture and additional intervention occurred.The patient was diagnosed with coronary artery disease (cad).A percutaneous transluminal coronary angioplasty was performed on a de novo lesion in the right coronary artery (rca).A 38 x 3.00 promus premier select stent was deployed in the rca.After deployment, the lesion was post dilated with a 12 x 3.5 nc balloon at 16 atmospheres.After post dilation, while taking orthogonal views of the deployed stent, a stent fracture was observed.A 12 x 3.5 promus premier select was deployed to cover the stent fracture.No further patient complications were reported in relation to this event and the patient was reported to be stable at the end of the procedure and stable following the procedure.It was further reported that the lesion was 85-90% stenosed and the rca was moderately tortuous and mildly calcified.The lesion was pre-dilated with 2.00x12 and 2.50x12 nc balloons at 14 atmospheres.There where no issues noted during stent deployment.
 
Manufacturer Narrative
Age at time of event: 18 years or older.
 
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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
MDR Report Key11123714
MDR Text Key225289558
Report Number2134265-2020-18273
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/24/2022
Device Model Number10668
Device Catalogue Number10668
Device Lot Number0025822573
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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