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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 9388
Device Problems Fracture (1260); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent fracture occurred.Vascular access was obtained via the femoral artery.The 80% stenosed concentric, de novo, target lesion was located in a non-tortuous and non-calcified left anterior descending artery.During delivery, the 3.00x24mm promus element plus drug eluting stent was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
 
Event Description
It was reported that stent fracture occurred.Vascular access was obtained via the femoral artery.The 80% stenosed concentric, de novo, target lesion was located in a non-tortuous and non-calcified left anterior descending artery.During delivery, the 3.00x24mm promus element plus drug eluting stent was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.It was further reported that the distal part of the stent struts was damaged.The device was completely removed from the patient's body.
 
Manufacturer Narrative
Device is a combination product.Describe event or problem updated.
 
Event Description
It was reported that stent fracture occurred.Vascular access was obtained via the femoral artery.The 80% stenosed concentric, de novo, target lesion was located in a non-tortuous and non-calcified left anterior descending artery.During delivery, the 3.00x24mm promus element plus drug eluting stent was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.It was further reported that the distal part of the stent struts was damaged.The device was completely removed from the patient's body.
 
Manufacturer Narrative
Device is a combination product.Describe event or problem updated.Device evaluated by mfr: promus element plus,mr,ous 3.00x24mm 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 was measured using snap gauge 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 tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft, as well as a hypotube break located 37.7cm distal to the distal strain relief.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A visual and microscopic examination of the bumper tip showed no signs of damage.
 
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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 Key9319063
MDR Text Key172006267
Report Number2134265-2019-13704
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/02/2021
Device Model Number9388
Device Catalogue Number9388
Device Lot Number0023450592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Date Manufacturer Received02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
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