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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 9551
Device Problems Fracture (1260); Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that difficulty removing a stent, a stent break, and a partial part of a stent remained in the patient. During a percutaneous coronary intervention, a 24 x 3. 50mm promus premier stent was partially deployed and became caught in the guide catheter. While removing the stent, part of the stent broke and remained in the radial artery. The stent was completely removed by using various techniques by three consultants. The procedure was completed with another device. No further patient complications were reported in relation to this event.

 
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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 Key10408627
MDR Text Key202965335
Report Number2134265-2020-10581
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9551
Device Catalogue Number9551
Device LOT Number0025178139
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 Received07/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/03/2020
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: 08/14/2020 Patient Sequence Number: 1
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