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

Model Number	1804225-18
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the left anterior descending (lad) artery with mild calcification and mild tortuosity.A 2.75x18mm xience stent was implanted mid lad, followed by a 3.00x28mm xience stent implanted proximal mid lad and then a 3.00x12mm xience stent was deployed to overlap the 2 implanted stents.The 2.50x33mm xience skypoint stent delivery system (sds) was attempted to be advance to the target lesion; however the sds got stuck and could not advance or be removed from the implanted 3.00x28mm xience stent; therefore, the stent was deployed at the proximal/mid lad, which was not the intended location.Additionally, the sds catheter became kinked.After the stent was deployed, the sds was removed from the patient.At an unknown point during the procedure a 2.25x18mm xience skypoint sds was attempted to be advanced in the guide catheter, but the shaft broke while advancing through the guide catheter.The 2.25x18mm xience skypoint sds was simply removed from the patient, without issue.There was no adverse patient sequela and no clinically significant delay in the procedure.The procedure was completed with the implantation of 2 non-abbott stents.No additional information was provided.
Additional Manufacturer Narrative
The device was not reported as returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 2.50x33mm xience skypoint stent is filed under a separate medwatch report number.
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 identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter causing the reported difficulty to advance and subsequent shaft separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
N/a.

• 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: 14964403
• Report Number: 2024168-2022-07420
• Device Sequence Number: 5372436
• Product Code: NIQ
• UDI-Device Identifier: 08717648233005
• UDI-Public: 08717648233005
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 07/29/2022

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: 07/25/2023
• Device Model Number: 1804225-18
• Device Catalogue Number: 1804225-18
• Device Lot Number: 1071441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X18MM, 3.00X28MM, 3.00X12MM XIENCE STENTS
• Patient Age: 61 YR
• Patient Sex: Male