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

Model Number	1804225-15
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 i suffered a heart attack.Dr.(b)(6) attempted to place a stent in the mid lad.The stent would not come off the balloon post full deployment, the stent had to be deployed in the left main where it got stuck.Due to damage caused by the stent being stuck on the balloon and pulled back, i suffered another more serious heart attack on (b)(6) 2022 that lead to an emergency double bypass surgery on (b)(6) 2022.The failure of the stent caused a second heart attack and double bypass.Fda safety report id # (b)(4).

• Brand Name: XIENCE SKYPOINT
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 15834394
• Report Number: MW5113383
• Device Sequence Number: 12043720
• Product Code: NIQ
• UDI-Device Identifier: 08717648232992
• UDI-Public: (01)08717648232992
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1804225-15
• Device Catalogue Number: 1804225-15
• Device Lot Number: 1080341
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White