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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493911316300
Device Problems Stent (515); Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. Age at time of event: 18 years or older. (b)(4).

 
Event Description

It was reported that stent damage occurred. Vascular access was obtained via the femoral artery. The 90% stenosed, 16mm x 3. 00mm target lesion was located in the severely tortuous and severely calcified left anterior descending artery. A 3. 00x16mm promus element ¿ stent was advanced to treat the lesion. However, the stent could not pass the lesion and it was observed that the stent was damaged. The device was removed from the patient 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 ¿
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7659864
MDR Text Key113272814
Report Number2134265-2018-05960
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
PMA/PMN NumberSIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/05/2019
Device MODEL NumberH7493911316300
Device Catalogue Number39113-1630
Device LOT Number0021362226
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/06/2017
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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