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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER PROMOUS ELITE; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER PROMOUS ELITE; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 23572140
Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problems Myocardial Infarction (1969); Foreign Body Embolism (4439)
Event Date 06/28/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, my husband had an angioplasty to check for blockage to his heart (was having chest pain).During the angioplasty the dr was inserting a stent in the right artery which got lodged in the artery before the area he wanted to place it.He then tried to pull the stent out and the wire broke.This caused (b)(6) to have a massive heart attack.This resulted in (b)(6) having to have emergency open heart surgery to replace the artery with the lodged stent.Being that he was given brilinta (blood thinner) for the angioplasty, made the surgery even more riskier.Attached product info form.
 
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Brand Name
PROMOUS ELITE
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER
MDR Report Key10553114
MDR Text Key207714523
Report NumberMW5096732
Device Sequence Number1
Product Code NIQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 09/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot Number23572140
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age72 YR
Patient Weight88
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