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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 Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred and the procedure was not completed.Vascular access was obtained via the radial artery.The 80% stenosed, 3.50x36mm de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.There was a significant bend between 45 and 90 degrees.A 3.50x38mm promus element plus drug-eluting stent was advanced for treatment but resistance was encountered and the stent was stuck due to calcification.After several attempts to advance the stent, the physician withdrew the device to perform pre-dilatation with a bigger balloon and upon removal, it was noted that the stent was damaged.Significant resistance had been encountered during repositioning and withdrawal of the device.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status was stable.
 
Manufacturer Narrative
Patient code corrected.
 
Event Description
It was reported that stent damage occurred and the procedure was not completed.Vascular access was obtained via the radial artery.The 80% stenosed, 3.50x36mm de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.There was a significant bend between 45 and 90 degrees.A 3.50x38mm promus element plus drug-eluting stent was advanced for treatment but resistance was encountered and the stent was stuck due to calcification.After several attempts to advance the stent, the physician withdrew the device to perform pre-dilatation with a bigger balloon and upon removal, it was noted that the stent was damaged.Significant resistance had been encountered during repositioning and withdrawal of the device.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status was stable.
 
Manufacturer Narrative
The promus element plus, mr, ous 3.50 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage with the struts on proximal end bunched distally.The undamaged crimped stent outer diameter was measured within maximum crimped stent profile measurement.The balloon body was reviewed; no issues were noted on the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.This device was loaded onto 0.014 guidewire without issue.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred and the procedure was not completed.Vascular access was obtained via the radial artery.The 80% stenosed, 3.50x36mm de novo target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.There was a significant bend between 45 and 90 degrees.A 3.50x38mm promus element plus drug-eluting stent was advanced for treatment but resistance was encountered and the stent was stuck due to calcification.After several attempts to advance the stent, the physician withdrew the device to perform pre-dilatation with a bigger balloon and upon removal, it was noted that the stent was damaged.Significant resistance had been encountered during repositioning and withdrawal of the device.The procedure was not completed due to this event.There were no patient complications nor injuries reported and the patient status 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 Key10080543
MDR Text Key191861491
Report Number2134265-2020-05835
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2020
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0022064550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2021
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age84 YR
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