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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10671
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 06/23/2020
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the right coronary artery.A 12 x 3.00 promus elite was advanced for treatment.However, a stent deformation from the proximal edge was noted.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the right coronary artery.A 12 x 3.00 promus elite was advanced for treatment.However, a stent deformation from the proximal edge was noted.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.It was further reported that the lesion was 80-90% stenosed, non-calcified and mildly tortuous.Another stent was used and overlapped to mitigate the issue of the implanted and deformed stent.
 
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Brand Name
PROMUS ELITE
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10255797
MDR Text Key198290705
Report Number2134265-2020-09183
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2022
Device Model Number10671
Device Catalogue Number10671
Device Lot Number0025221580
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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