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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 9390
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2020
Event Type  malfunction  
Event Description
It was reported that stent dislodgement occurred.A 2.25x28mm promus element plus drug-eluing stent was selected for use.However, the stent dislodged during unpacking.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: promus element plus ous mr 2.25 x 28 mm stent delivery system was returned for analysis without the stent.The device was returned without the stent.A review of the manufacturing stent profile data was within max crimped stent profile measurement.The balloon cones were reviewed, and no signs of positive pressure were noted as its wings were folded.Crimp markings are visible on the exposed balloon.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found no issues.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent dislodgement occurred.A 2.25x28mm promus element plus drug-eluing stent was selected for use.However, the stent dislodged during unpacking.The procedure was completed with another of the same device.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 Key10970843
MDR Text Key220429999
Report Number2134265-2020-17110
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 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2022
Device Model Number9390
Device Catalogue Number9390
Device Lot Number0025571552
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Date Manufacturer Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age79 YR
Patient Weight56
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