MAUDE Adverse Event Report: ABBOTT MEDICAL / ABBOTT VASCULAR ABBOTT XIENCE SKYPOINT STENT 2.5MM X 15 MM; CORONARY DRUG-ELUTING STENT

Model Number	1804250-15
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Wire was added for support to advance the stent.When the stent was needed to reinsert, it was noted to have a stent strut protruding out of the stent.The stent did not reenter the body and was removed from the field and a new stent was obtained.No apparent side affects were noted.Fda safety report id# (b)(4).

• Brand Name: ABBOTT XIENCE SKYPOINT STENT 2.5MM X 15 MM
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT MEDICAL / ABBOTT VASCULAR
• MDR Report Key: 15216893
• Report Number: MW5111443
• Device Sequence Number: 5915064
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: 08717648233074
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: 1804250-15
• Device Catalogue Number: 1804250-15
• Device Lot Number: 1120841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White