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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE; CORONARY DRUG-ELUTING STENT
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ABBOTT VASCULAR XIENCE; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number THHBDV #73013 MRN 549696
Device Problem Partial Blockage (1065)
Patient Problem Myocardial Infarction (1969)
Event Date 07/09/2016
Event Type  Injury  
Event Description
Reporter stated she had a heart attack in (b)(6) 2016.She started off with a cardio rehab and instead of feeling better, felt worst.She had shortness of breath and went to the hospital.After cardiac monitoring, the drs discovered that the stent was 100% blocked.Reporter continues to experience symptoms of a heart attack in an attempt to clear the stent, the balloon blocked in the coronary artery.The drs pushed the balloon to the tip of artery and put a stent on each side of the artery to hold it in place.She was administered effient to prevent blood clots.Reporter is worried and afraid to travel out of (b)(6) or do anything for fear of dislocating the device.Reporter states that the mfr refuses to take responsibility regarding this faulty device.
 
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Brand Name
XIENCE
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
ABBOTT VASCULAR
3200 lakeside dr.
santa clara CA 95054
MDR Report Key7373007
MDR Text Key103660693
Report NumberMW5076123
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberTHHBDV #73013 MRN 549696
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age72 YR
Patient Weight79
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