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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9394
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2020
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent profile problem occurred.The target lesion was located in a coronary artery.A 3.00x38mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent was too long after releasing.The procedure was completed with non-bsc stent with different sizes.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: promus element plus,mr,ous 3.00x38mm 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 stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The stent length was measured and the result was within the stent length specification.The balloon was 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 tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues.No issues were identified during the product analysis.
 
Event Description
It was reported that stent profile problem occurred.The target lesion was located in a coronary artery.A 3.00x38mm promus element plus drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent was too long after releasing.The procedure was completed with non-bsc stent with different sizes.There were no patient complications reported and the patient was stable.
 
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Brand Name
PROMUS ELEMENT PLUS
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10247642
MDR Text Key198020643
Report Number2134265-2020-08272
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 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/23/2021
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0024518121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Initial Date Manufacturer Received 06/16/2020
Initial Date FDA Received07/08/2020
Supplement Dates Manufacturer Received07/24/2020
Supplement Dates FDA Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight66
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