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

Model Number 1804225-15

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem Myocardial Infarction (1969)

Event Date 02/16/2022

Event Type  Injury  

Event 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
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 15834394
• MDR Text Key: 304115312
• Report Number: MW5113383
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648232992
• UDI-Public: (01)08717648232992
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804225-15
• Device Catalogue Number: 1804225-15
• Device Lot Number: 1080341
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White