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

Catalog Number	1804400-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/17/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient presented with a non-st-elevation myocardial infarction and the procedure was to treat a lesion in the right coronary artery (rca) with moderate to severe calcification.An intravascular lithotripsy (ivl) catheter was used for calcium modification, however, a dissection occurred in the mid rca.The 4.5x15mm nc trek neo balloon dilatation catheter (bdc) was used without issues and then a 4.0x33mm xience skypoint stent delivery system (sds) was used to treat the dissection.Another 2 nc trek neo balloons, 4.5x12mm and 4.5x15mm, were used without issues and a 4.5x15mm xience skypoint stent was implanted successfully in the proximal rca.Another 4.5x12mm nc trek neo balloon was used for post dilatation and inflated to 30 atmospheres (atms) when a perforation occurred in the mid rca.The physician then used a 4.0x20mm trek balloon as a tamponade then placed a non-abbott covered stent to treat the perforation, however, at that point the patient already expired.Reportedly, the cause of death was the perforation.There was 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.The reported patient effects of death and perforation are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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.

• 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: 18253527
• Report Number: 2024168-2023-13375
• Device Sequence Number: 6572162
• Product Code: NIQ
• UDI-Device Identifier: 08717648233517
• UDI-Public: 08717648233517
• 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
• 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): 12/03/2023

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: 08/18/2024
• Device Catalogue Number: 1804400-33
• Device Lot Number: 108144B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: 4.5X12MM NC TREK NEO BALLOON; 4.5X15MM XIENCE SKYPOINT STENT
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown