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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 10674
Device Problems Material Rupture (1546); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 24x3.00mm promus elite mr stent was advanced to treat the lesion.However, during deployment at 11 atmospheres, dog bone effect was noted on the balloon and when the physician increased the pressure for 32 seconds, balloon ruptured.The stent was successfully deployed and the device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 24x3.00mm promus elite mr stent was advanced to treat the lesion.However, during deployment at 11 atmospheres, dog bone effect was noted on the balloon and when the physician increased the pressure for 32 seconds, balloon ruptured.The stent was successfully deployed and the device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the target lesion was concentric, containing <45 degrees bend and pre-dilated with nc balloon.
 
Manufacturer Narrative
Device is a combination product.B5 - describe event or problem updated.Device evaluated by mfr: p elite ous mr 24 x 3.00 mm stent delivery system was returned for analysis with the hemostatic valve attached to the manifold hub.A red/brown blood like substance was noted inside the closed hemostatic valve.A visual and microscopic evaluation of the stent could not be performed as the stent of the device was not returned as it was deployed at the lesion site.The balloon was reviewed, and signs of positive pressure were noted.However, the balloon folds were not fully expanded, and crimp markings were still visible on the exposed balloon body which is a sign of only partial pressure being applied to the balloon cones.A red/brown blood like substance was noted on the balloon.A visual and microscopic examination of the bumper tip showed signs of damage on the distal end of the tip.A visual and tactile examination of the hypotube shaft found no issues.A red/brown blood like substance was noted in the manifold hub.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen and found no issues.An inflation/deflation test was attempted using an encore device verified with a druck gauge to 16 atm.Gradual loss of pressure in the inflation device was noted and was due to a leak originating in a pinhole on the proximal balloon cone.A review of the media provided could identify the alleged balloon material deformation as a constriction in the mid stent region was identified but with proximal and distal stent regions (and balloon cones implicitly) expanded.This restriction in the mid region is giving the whole stent a dog bone like appearance hence the alleged complaint.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 Key10278262
MDR Text Key199086434
Report Number2134265-2020-08916
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 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/03/2021
Device Model Number10674
Device Catalogue Number10674
Device Lot Number0024581533
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Date Manufacturer Received08/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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