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

Model Number	1804275-15
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An elderly male in cath lab: abott xience skypoiknt 2.75x 15 drug-eluting stent inserted would not cross the lesion.Upon removing the stent delivery system it was noted that the stent was not on the delivery system, and left in body.A 1.5 emerge balloon was placed in the body, inflated and removed the dislodged stent.Patient to pacu in stable condition.Preparing patient now for discharge 1 day-post procedure.

• Brand Name: XIENCE SKYPOINT
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; m/s te520; temecula CA 92591
• MDR Report Key: 14141068
• Report Number: 14141068
• Device Sequence Number: 17715064
• Product Code: NIQ
• UDI-Device Identifier: 08717648233159
• UDI-Public: (01)08717648233159
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/24/2022
• Report Date (Section F): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1804275-15
• Device Catalogue Number: 1804275-15
• Device Lot Number: 1072141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White
• Date Report Sent to FDA: 03/24/2022