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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 10677
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent fracture occurred.The target lesion was located in the left anterior descending artery.After deploying a 38x2.75mm promus elite drug-eluting stent, it was noticed that the mid segment of the stent got fractured.A 2.5x28mm non-bsc stent was then deployed in the same stent segment and the procedure was completed.No patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that stent fracture occurred.The target lesion was located in the left anterior descending artery.After deploying a 38x2.75mm promus elite drug-eluting stent, it was noticed that the mid segment of the stent got fractured.A 2.5x28mm non-bsc stent was then deployed in the same stent segment and the procedure was completed.No patient complications were reported and the patient's status was stable.It was further reported that the target lesion was 95% stenosed, non-calcified and mildly tortuous.
 
Manufacturer Narrative
Device is a combination product.
 
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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 Key9194375
MDR Text Key162518459
Report Number2134265-2019-12206
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 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10677
Device Catalogue Number10677
Device Lot Number0023787542
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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