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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 9550
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiogenic Shock (2262)
Event Date 04/05/2019
Event Type  Death  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is combination product.
 
Event Description
It was reported that cardiogenic shock and death occurred.The target lesion was located in the left anterior descending artery.Two promus premier drug-eluting stents were implanted, a 20 x 3.50mm and a 28 x 2.50mm.However, post implant, an edge dissection was noted at the distal end of the 28x2.50mm stent.The patient went into cardiogenic shock and died.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device is combination product.
 
Event Description
It was reported that cardiogenic shock and death occurred.The target lesion was located in the left anterior descending artery.Two promus premier drug-eluting stents were implanted, a 20 x 3.50mm and a 28 x 2.50mm.However, post implant, an edge dissection was noted at the distal end of the 28x2.50mm stent.The patient went into cardiogenic shock and died.It was further reported that the patient presented with severe left ventricle (lv) dysfunction and cardiogenic shock.During angioplasty, a minor dissection also occurred at the proximal end of the 28 x 2.50mm stent.The dissection was covered with the 20 x 3.50mm stent.The patient collapsed between the procedure because of poor lv function and cardiogenic shock.The cause of death was listed as cardiogenic shock.
 
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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
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8504833
MDR Text Key141624190
Report Number2134265-2019-03765
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 company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/27/2020
Device Model Number9550
Device Catalogue Number9550
Device Lot Number0023054635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2019
Initial Date FDA Received04/11/2019
Supplement Dates Manufacturer Received04/15/2019
Supplement Dates FDA Received04/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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