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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 9384
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem Perforation (2001)
Event Date 10/14/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that vessel perforation occurred.The eccentric target lesion was located in the moderately calcified left circumflex artery.A 2.25x16mm promus element plus drug-eluting stent was advanced but failed to cross.It was noted that the stent got damaged and vessel perforation was observed.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that vessel perforation occurred.The eccentric target lesion was located in the moderately calcified left circumflex artery.A 2.25x16mm promus element plus drug-eluting stent was advanced but failed to cross.It was noted that the stent got damaged and vessel perforation was observed.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.It was further reported that a balloon was inflated at the site of perforation and was held for a long time.
 
Manufacturer Narrative
Device is a combination product.
 
Manufacturer Narrative
Device is a combination product.A promus element plus 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 crimped stent outer diameter was measured 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 a kink measured at 153 mm distal to the distal end of the strain relief.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.
 
Event Description
It was reported that vessel perforation occurred.The eccentric target lesion was located in the moderately calcified left circumflex artery.A 2.25x16mm promus element plus drug-eluting stent was advanced but failed to cross.It was noted that the stent got damaged and vessel perforation was observed.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.It was further reported that a balloon was inflated at the site of perforation and was held for a long time.
 
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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 Key9354278
MDR Text Key167377300
Report Number2134265-2019-14243
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 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/02/2020
Device Model Number9384
Device Catalogue Number9384
Device Lot Number0022626440
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Date Manufacturer Received12/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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