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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
Device Problems Fracture (1260); Device Damaged by Another Device (2915)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.Date of event: estimated based on bsc aware date of (b)(6) 2019.
 
Event Description
It was reported via twitter feed that stent damage post deployment occurred.A percutaneous coronary intervention was being performed in a tortuous lesion.The promus premier stent was difficult to advance and severe foreshortening stent strut fractures occurred while negotiating the balloon.
 
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Brand Name
PROMUS PREMIER
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8713922
MDR Text Key148534200
Report Number2134265-2019-07022
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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