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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 Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Patient Problem No Patient Involvement (2645)
Event Date 06/25/2020
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product.

 
Event Description

It was reported that device entrapment occurred. After wiring the lesion, a 3. 50x32mm promus element plus drug-elutig stent was selected for use. However, the stent failed to pass over the wire in the part outside the patient's body. The device became stuck on the wire and no ante or retro movement was noted. Eventually, the device was removed and 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 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 Key10275903
MDR Text Key198874556
Report Number2134265-2020-08935
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeEG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device Was Involved in the Event
0 PatientS WERE 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 Date04/16/2020
Device MODEL Number9392
Device Catalogue Number9392
Device LOT Number0022041274
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/15/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2018
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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