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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493952816250
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Discomfort (2330); Diaphoresis (2452)
Event Date 06/12/2018
Event Type  Injury  
Manufacturer Narrative

Device is a combination product. Device evaluated by mfr: the device was not received for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling. (b)(4).

 
Event Description

Same case as mdr id # 2134265-2018-06025. It was reported that patient discomfort and complications occurred. Vascular access was obtained via the radial artery. A promus premier¿ stent was implanted the obtuse margin. After the procedure, upon transportation back to the patient's room, the patient became diaphoretic and was brought back to the catheterization lab. The previously implanted stent was widely patent, however, there was a focal lesion in the right coronary artery (rca) that had been undetected. A promus premier¿ stent was then placed in the rca. After the second stent was implanted, the patient's arm was "frozen" and severely uncomfortable. The patient's current status is okay.

 
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Brand NamePROMUS PREMIER¿
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 Key7682078
MDR Text Key113787028
Report Number2134265-2018-06026
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 06/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/11/2018
Device MODEL NumberH7493952816250
Device Catalogue Number39528-1625
Device LOT Number20181488
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2017
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: 07/12/2018 Patient Sequence Number: 1
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