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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 9386
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : promus element plus 3. 50x20 mm stent delivery system (sds) was returned for analysis. An examination of the crimped stent found stent damage. Stent struts from the proximal end of the stent were noted to be lifted from their crimped position and pulled distally. The undamaged crimped stent outer diameter was measured and the result 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 l tip damage. A visual and tactile examination of the hypotube shaft 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. The device was loaded without issues on a 0. 014" test guidewire. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on (b)(6) 2020. It was reported that advancing difficulties were encountered. The 50-95% stenosed target lesion was located in the severely tortuous right coronary artery. A 3. 50x20mm promus element plus drug-eluting stent was advanced but failed to reach the lesion after multiple attempts. The procedure was completed with a different device. There were no patient complications reported and the patient's 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 Key10555426
MDR Text Key207591246
Report Number2134265-2020-11913
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 09/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9386
Device Catalogue Number9386
Device LOT Number0024499621
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/07/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/16/2019
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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