MAUDE Adverse Event Report: EVEROLIMUS ZORTRESS AFINITOR STENTS

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.

• Brand Name: EVEROLIMUS ZORTRESS AFINITOR STENTS
• Type of Device: EVEROLIMUS ZORTRESS AFINITOR STENTS
• MDR Report Key: 7769703
• MDR Text Key: 116895003
• Report Number: MW5079021
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• 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 Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 88 YR
• Patient Weight: 81