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

Lot Number 2101741

Patient Problems Hypersensitivity/Allergic reaction (1907); Myocardial Infarction (1969); Rash (2033); Obstruction/Occlusion (2422); Unspecified Respiratory Problem (4464); 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 and not really healing up.But some doctors seen have acted very concerned and some have acted like it's no big deal.Reference report: mw5149000.Refer to add'l documents in i2k.

• Brand Name: XIENCE SKYPOINT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULARR
• MDR Report Key: 18290776
• MDR Text Key: 330272782
• Report Number: MW5149001
• 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

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 2101741
• Was Device Available for Evaluation?: Yes
• 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