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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 Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the left circumflex artery.A 2.50x38mm promus element plus stent was advanced to treat the lesion.However, the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: promus element plus,mr,ous 2.50x38mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found damage to the stent.The proximal end of the stent was damaged with stent struts pulled distally.The undamaged crimped stent outer diameter was within max 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 multiple kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.The target lesion was located in the left circumflex artery.A 2.50x38mm promus element plus stent was advanced to treat the lesion.However, the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's 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 Key8207321
MDR Text Key131762301
Report Number2134265-2018-64711
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 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/22/2020
Device Model Number9394
Device Catalogue Number9394
Device Lot Number0022050451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2019
Date Manufacturer Received02/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight75
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