MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1804225-33
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous lesion in the left anterior descending (lad) artery.Reportedly, a 2.25x33mm xience skypoint drug eluting stents (des) was attempted to be advanced, but the guide catheter (gc) tip was damaged, and the des could not reach the lesion.The first stent was difficult to remove because the guide catheter tip was damaged and prevented the stent from easily being retracted.The gc was replaced and another 2.5x33mm skypoint des was advanced, however the vessel was tortuous, and the guide catheter had difficulty navigating the tortuous anatomy and kept ¿popping out¿ of the left coronary ostium.The deployer also realized that the 2.5x33mm des was the incorrect size.The des did not reach the target lesion.A 2.5x15mm was then advanced but again, the vessel was tortuous, and the guide catheter had difficulty navigating the tortuous anatomy and could not advance to the lesion.It was also determined that the lesion needed more preparation.A 3x28mm was then attempted but the vessel was tortuous, and the guide catheter had difficulty navigating the tortuous anatomy, and this size stent did not work as well.The des could not reach the lesion to be treated.After further vessel preparation and using a shorter length stent, they were able to treat the target lesion and successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12775923
• Report Number: 2024168-2021-10140
• Device Sequence Number: 3485602
• Product Code: NIQ
• UDI-Device Identifier: 08717648233036
• UDI-Public: 08717648233036
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 03/24/2023
• Device Model Number: 1804225-33
• Device Catalogue Number: 1804225-33
• Device Lot Number: 1031941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male