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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10676
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.
 
Event Description
It was reported that shaft break occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 2.75 mm x 30 mm, concentric, de novo target lesion with a significant bend of >=90 degrees was located in the severly tortuous and calcified right coronary artery.The lesion was engaged coaxially with a 7f jr guide catheter and was crossed with a non-bsc guide wire.After pre-dilatation was performed with a maverick 2 balloon catheter, a 32x2.50mm promus elite drug-eluting stent (des) was advanced but failed to track the lesion.The device was withdrawn and further dilatation was performed with a 2.5x12mm maverick balloon catheter.After dilatation, the stent was re-inserted however, the hypotube was cut in the distal end.The device was removed and a new 32x2.50mm promus elite des was used and completed the procedure.Post procedure, the outcome was good and the patient was stable.
 
Event Description
It was reported that shaft break occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, 2.75 mm x 30 mm, concentric, de novo target lesion with a significant bend of >=90 degrees was located in the severly tortuous and calcified right coronary artery.The lesion was engaged coaxially with a 7f jr guide catheter and was crossed with a non-bsc guide wire.After pre-dilatation was performed with a maverick 2 balloon catheter, a 32x2.50mm promus elite drug-eluting stent (des) was advanced but failed to track the lesion.The device was withdrawn and further dilatation was performed with a 2.5x12mm maverick balloon catheter.After dilatation, the stent was re-inserted however, the hypotube was cut in the distal end.The device was removed and a new 32x2.50mm promus elite des was used and completed the procedure.Post procedure, the outcome was good and the paitent was stable.
 
Manufacturer Narrative
(a2) age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr.:promus elite ous mr 32 x 2.50 mm 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 marker bands.The crimped stent outer diameter was measured and the result is 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 signs of damage.A visual and tactile examination of the hypotube found multiple kinks and no evidence of a break.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
 
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Brand Name
PROMUS ELITE
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9642017
MDR Text Key178640813
Report Number2134265-2020-00643
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,foreig
Type of Report Initial,Followup
Report Date 03/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/09/2021
Device Model Number10676
Device Catalogue Number10676
Device Lot Number0024120380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Date Manufacturer Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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