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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 9392
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. Device evaluated by mfr. : promus element plus, mr, ous 2. 50x32mm stent delivery system was returned for analysis. A visual examination of the stent found signs of stent damage. Stent struts in the mid section of the stent were lifted and pulled proximally. The undamaged 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 no signs of damage. A visual and tactile examination of the hypotube found no issues. A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 18-aug-2020. It was reported that advancing difficulties were encountered. The severely tortuous and severely calcified target lesion was located in the mid left anterior descending artery. Following pre-dilatation, a 2. 50x32mm promus element plus drug-eluting stent was advanced for treatment. However, even after several attempts, the stent could not reach the lesion. The procedure was not completed. No patient complications were reported and patient status was stable. However, returned device analysis revealed stent damage.

 
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Brand NamePROMUS ELEMENT PLUS
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10512532
MDR Text Key206546679
Report Number2134265-2020-12016
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9392
Device Catalogue Number9392
Device LOT Number0024038480
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/27/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/25/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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