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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 Problems Premature Activation (1484); Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 02/14/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that premature deployment occurred.A 2.25x28mm promus element plus drug-eluting stent was selected for use.However, during preparation, it was noted that the stent was released before it entered into the patient's body.The procedure was completed with a different device and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.It was reported that premature deployment occurred was initially reported.The correct statement should have been: it was reported that stent dislodgement occurred.Device code description: premature activation was initially reported.The correct code should have been device dislodged or dislocated.(2923).
 
Event Description
It was reported that stent dislodgement occurred.A 2.25x28mm promus element plus drug-eluting stent was selected for use.However, during preparation, it was noted that the stent was released before it entered into the patient's body.The procedure was completed with a different device and the patient's status was stable.
 
Event Description
It was reported that stent dislodgement occurred.A 2.25x28mm promus element plus drug-eluting stent was selected for use.However, during preparation, it was noted that the stent was released before it entered into the patient's body.The procedure was completed with a different device and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.Corrections: (b5) describe event or problem: it was reported that premature deployment occurred was initially reported.The correct statement should have been: it was reported that stent dislodgement occurred.(h6) device code description: premature activation was initially reported.The correct code should have been device dislodged or dislocated.(2923).Device evaluated by mfr: promus element plus, mr, ous 2.25x28mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts from the proximal end of the stent bunched distally.The undamaged stent was measured and the result was within maximum crimped stent profile measurement.The balloon cones were 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 microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube 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 along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
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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 Key9913689
MDR Text Key186097243
Report Number2134265-2020-03894
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,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/10/2021
Device Model Number9390
Device Catalogue Number9390
Device Lot Number0023670251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Date Manufacturer Received06/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
Patient Weight49
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