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

Model Number	1804275-18
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Stent used during coronary ptca was unable to be advanced, so it was removed.There was difficulty removing it through the guard catheter.Everything was pulled out, catheter, guidewire and stent.Upon observation, the stent had become torn or damaged at the base.Abbott xience skypoint 2.75 mm x18 mm, ref 1804275-18, lot 1120641.Fda safety report id # (b)(4).

• Brand Name: XIENCE SKYPOINT
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 15077750
• Report Number: MW5111021
• Device Sequence Number: 3953795
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: (01)08717648233166(17)231212
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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 Expiration Date: 12/12/2023
• Device Model Number: 1804275-18
• Device Catalogue Number: 1804275-18
• Device Lot Number: 1120641
• 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: 07/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White