MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT (3.5MM X 38MM) EVEROLIMUS ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number 1804350-38

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687); Respiratory Arrest (4461)

Event Date 08/23/2023

Event Type  Injury  

Event Description

Stent fell off delivery balloon during implant and it needed snared out of her lad/lm(left anterior descending artery/left main artery).There was a prolonged episode resuscitation with multiple shocks and endotracheal intubation.

• Brand Name: XIENCE SKYPOINT (3.5MM X 38MM) EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 17682629
• MDR Text Key: 322729535
• Report Number: MW5145131
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804350-38
• Device Lot Number: 3050441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "MULTIPLE SHOCKS"; ENDOTRACHEAL INTUBATION
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White