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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EVEROLIMUS ZORTRESS AFINITOR STENTS

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EVEROLIMUS ZORTRESS AFINITOR STENTS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Edema (1820); Hair Loss (1877); Itching Sensation (1943); Swelling (2091); Reaction (2414); Weight Changes (2607)
Event Date 03/31/2017
Event Type  Injury  
Event Description
(b)(6) stent implants had "everolimus coating. " and severe allergic reaction occurred over several months. Physicians not find cause. Edema (generalized) from (b)(6) 2017, over 6 months grew worse, 30lb weight gain, moon face, pedal and leg edema caused him to fall off, start using cane, (b)(6) , eyes swollen nearly shut, finally, "dr (b)(6)" started lasix and prednisone and slowly edema decreased but still evident. The itching was most severe, and nothing's helped. Now, slowly symptoms are improving - weight decreased some. My dermatologist (long standing), dr (b)(6) ((b)(6)) thought i might have grovers disease but "i saw dr (b)(6,) my reg cardiologist not in" and he recognized the problem was likely allergy to coating on stents. Started prednisone large doses and lasix. Dr (b)(6) (stent surgeon) concurred, it started to improve. I was very sick - now slowly recovering. Today (b)(6) use a cane, eye still swollen but rash - itch, weight decreased (b)(6), was (b)(6). Legs still edematous. My hair is starting to grow back. Dr (b)(6) said the stent coating will eventually be excreted and everything will continue to improve. You report the critical point now. Lost hair - severe edema, uncontrolled itching, eye injury, (b)(6), declining health. Reason for use: coronary arteries blockage.
 
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Brand NameEVEROLIMUS ZORTRESS AFINITOR STENTS
Type of DeviceEVEROLIMUS ZORTRESS AFINITOR STENTS
MDR Report Key7769703
MDR Text Key116895003
Report NumberMW5079021
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
Type of Report Initial
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/08/2018 Patient Sequence Number: 1
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