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

Catalog Number 1804350-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Thrombosis/Thrombus (4440)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a 90% stenosed moderately calcified, moderately tortuous distal left circumflex lesion.A 3.50 x 23 xience skypoint stent delivery system (sds) was successfully implanted.Two days after the stent was implanted, an emergent procedure was performed as the patient had atrial fibrillation.Defibrillation was performed and red thrombus was confirmed on the distal position of the stent using optical coherence tomography.The thrombosis was treated with thrombus aspiration and atherectomy.No additional information was provided.

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(s) of thrombosis and atrial fibrillation are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: 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: 18360308
• MDR Text Key: 330931894
• Report Number: 2024168-2023-14227
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: 08717648233418
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1804350-23
• Device Lot Number: 3052341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization