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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9548
Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problems Discomfort (2330); No Code Available (3191)
Event Date 09/01/2020
Event Type  Injury  
Event Description

It was reported that stent dislodgement occurred. The target lesion was located in the heavily calcified and previously stented left anterior descending artery/diagonal vessel. Predilatation was performed with drug-eluting balloon catheter. The patient experienced some discomfort during inflation but was otherwise was okay. A 12 x 2. 25 promus premier drug-eluting stent was advanced for treatment. However, the device failed to deliver and it came off the balloon upon removal. Subsequently, the undeployed stent was crushed with another stent in the left main. Patient was admitted for 48 hours for observation and was discharged after.

 
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Brand NamePROMUS PREMIER
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 Key10520461
MDR Text Key206491382
Report Number2134265-2020-12617
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9548
Device Catalogue Number9548
Device LOT Number0024823929
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/20/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/11/2020 Patient Sequence Number: 1
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