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

Model Number	1804225-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the circumflex (cx) artery.The patient anatomy included 1 unspecified stent, implanted approximately 8 months ago in the left main, and extending into the ostium of the cx artery.A 3.5 x 15 mm xience skypoint was implanted in the cx, a 2.25 x 12 mm xience skypoint was implanted in the mid cx and a 2.5 x 15 mm xience skypoint was implanted in the left anterior descending artery.It was noted that a possible dissection had occurred at the proximal cx; therefore, a 2.25 x 8 mm xience skypoint stent delivery system was advanced to the cx artery, to treat the dissection.The xience skypoint was advanced to the target site; however, due to interaction with the previously implanted left main stent, the xience skypoint stent was unable to cross.During removal, the xience skypoint stent caught on the left main stent and dislodged.There were no attempts to remove the dislodged stent, and the stent was crushed to the vessel wall.As the dissection was unable to be confirmed, no additional intervention was performed to treat the possible dissection.The procedure ended with the patient in stable condition.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.The reported patient effect of dissection is listed in the xience skypiont everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience skypoint stent referenced in b5 is filed under separate medwatch report number.

• 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: 17148438
• Report Number: 2024168-2023-06403
• Device Sequence Number: 5757895
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: 08717648232985
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• Device Model Number: 1804225-12
• Device Catalogue Number: 1804225-12
• Device Lot Number: 2081941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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: 3.5X15MM, 2.5X15MM XIENCE SKYPOINT STENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 164 KG