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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 9553
Device Problems Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2021
Event Type  malfunction  
Event Description
It was reported that stent damage occurred. Vascular access was obtained via the radial artery. The 30mmx3. 5mm, de novo, eccentric target lesion containing a >45 and <90 degrees bend was located in the moderately tortuous and severely calcified right coronary artery. After the lesion was crossed with a 0. 014 non-boston scientific guidewire, pre-dilatation was performed with 2. 5x20 and 3x15 sc balloon catheters. Following pre-dilatation, a 32 x 3. 50 promus premier drug-eluting stent was advanced for treatment. However, during the procedure, the device was stuck and failed to advance. Subsequently, a 3. 5x12 nc balloon catheter was used and advanced the stent again but some of the stent sells was damaged. The procedure was completed with another smaller stent. There were no patient complications reported and the patient status was stable.
 
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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 Key12708686
MDR Text Key278795337
Report Number2134265-2021-13508
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeTS
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 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/10/2021
Device Model Number9553
Device Catalogue Number9553
Device Lot Number0024784676
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 Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2019
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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