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

Model Number 1804225-18

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

First stent deployed in rca (right coronary artery), attempted to deploy 2nd stent distal to first.Stent came off wire inside of first stent.2nd stent left undeployed inside.

• Brand Name: XIENCE SKYPOINT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 12868211
• MDR Text Key: 281218929
• Report Number: 12868211
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804225-18
• Device Catalogue Number: 1804225-18
• Device Lot Number: 1032441
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29200 DA
• Patient Sex: Female
• Patient Weight: 81 KG