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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 07/06/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : promus element plus,mr,ous 2. 25x32mm stent delivery system was returned for analysis. A visual examination of the stent found stent damage. Stent struts on the proximal region were lifted, bunched and pulled in a distal direction. The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement. The balloon was 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 tactile examination of the hypotube found multiple kinks. A visual and tactile examination of the shaft polymer extrusion found no issues. An examination (visual and via scope) of the tip found no issues. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 07-sep-2020. It was reported that advancing difficulties were encountered. The target lesion was located in the mid left anterior descending artery with severe stenosis and calcification. After pre-dilatation was performed, a 2. 25x32mm promus element plus drug-eluting stent was advanced but the stent could not reach the lesion even after multiple attempts. The procedure was completed with another of the same device. 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 Key10610854
MDR Text Key209350145
Report Number2134265-2020-12547
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 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
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 Number0024038149
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2020
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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