MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT; CORONARY DRUG-ELUTING STENT

Lot Number 2101741

Patient Problems Myocardial Infarction (1969); Rash (2033); Swelling/ Edema (4577)

Event Date 03/10/2023

Event Type  Injury  

Event Description

On date above had major heart attack with stent placed.15 days later had another heart attack & another stent placed which was 90% blocked at the time of my first heart attack.(b)(6) 2023 they put me on brilinta.I got a rash that looked like sun poisoning almost immediately also swelling across my nose with lots of snot going down my throat & my throat closing/swelling up.Now here eight months later the "rash" is extreme & has overtaken my whole body almost.It just started out on one of my forearms.On (b)(6) 2023 doctors added norvasc to my medications & and that's when we noticed the rash became unbearable.It's still going on & not really healing up.But some doctors seen have acted very concerned & some have acted like it's no big deal.Reference report: mw5149001.Refer to add'l documents in i2k.

• Brand Name: XIENCE SKYPOINT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 18290762
• MDR Text Key: 330226405
• Report Number: MW5149000
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 2101741
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Patient Sequence Number: 1
• Treatment: 2 STENTS; AMLODIPINE BESYLATE; ASPIRIN 81MG; ATORVASTATIN 80MG; BRILINTA; ISOSORBIDE MONONITRATE 30MG; LOSARTAN 100M; METOPROLOL SUCCINATE ER 50MG; NITRO0.4MG; NORVASC; PREDNISONE 50MG - 5MG TAPERING; TYLENOL.... MAYBE ONCE A MONTH
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White