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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION PROMUS ELITE STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10671
Device Problems Inflation Problem (1310); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2021
Event Type  Injury  
Event Description
It was reported that a balloon hole, failure to fully inflate, and additional intervention occurred. A 12 x 3. 00 promus elite mr stent was advanced to the target lesion, but it was noticed that there was a hole in it and would not fully inflate. However, the stent was deployed and the stent was fully apposed by using a non compliant (nc) balloon. The procedure was completed. No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
 
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Brand NamePROMUS ELITE
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 Key11368647
MDR Text Key233239842
Report Number2134265-2021-02155
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/10/2022
Device Model Number10671
Device Catalogue Number10671
Device Lot Number0025757862
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2020
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: 02/23/2021 Patient Sequence Number: 1
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