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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE; CORONARY DRUG-ELUTING STENT
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ABBOTT VASCULAR XIENCE ALPINE; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 7062041
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Atherosclerosis (1728)
Event Date 08/12/2018
Event Type  Injury  
Event Description
Was given 2 stents that i didn't want or agree to.Was not advised of the side effects as i was drugged.At first, my medical records stated i would have to have dapt for 12 months, then by next day it changed to over 12 months, and now it has changed to forever.The stents apparently damage the artery walls thus keeping the arteries thinking that they have to constantly be in a healing process by producing a type of cholesterol called lipoprotein or lp(a).The cracks or damaged area are repaired with a fatty patch.Eventually these fatty patches grow with platelets, calcium that form the atherosclerotic plaque that leads to disease.Since i now have 2 metal meshes in my arteries, my arteries will forever thick they need to try to heal, thus making me more likely to have another blockage.The medicine i now have to take make me dizzy, short of breath, cough, tired, memory loss, muscle loss.The dr i went to did not write down the side effects but stated in my medical records that i was tolerating the meds well and told me verbally to "suck it up.".
 
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Brand Name
XIENCE ALPINE
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key8432450
MDR Text Key139286844
Report NumberMW5084985
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 03/14/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number7062041
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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