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

Catalog Number	1804325-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with shortness of breath and the procedure was to treat a lesion in the mid to distal left anterior descending (lad) artery with heavy calcium and moderate tortuosity.Lithotripsy was performed.Two xience skypoint stents, 3.25x38mm (distal part of the lad) and then 4.0x38mm (mid portion of the lad), were implanted.Stents were post dilatated per standard procedure and intravascular ultrasound (ivus) imaging was obtained post stent dilatation.There was no adverse patient effect and there was no clinically significant delay in the procedure.The patient was taken back to the room; however, about 30-45 minutes later, the patient complained about chest pain.An electrocardiogram (ekg) was performed and showed anterior myocardial infarction (mi) on the ekg.The patient was brought back to the lab and after performing the angiogram the 3.23x38 stent was noted to be blocked off.It was determined that the stent 100% thrombosed and had to be opened.In the lab, the patient needed cpr so the patient was intubated and impella device was inserted to provide support.A couple days later the patient was transferred to another facility.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Lot history record (lhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The reported patient effect(s) of angina, thrombosis and myocardial infarction 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.

• 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: 19139866
• Report Number: 2024168-2024-04856
• Device Sequence Number: 13116851
• Product Code: NIQ
• UDI-Device Identifier: 08717648233364
• UDI-Public: (01)08717648233364(17)260201(10)3021041
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Catalogue Number: 1804325-38
• Device Lot Number: 3021041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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: 4.0X38MM XIENCE SKYPOINT STENT.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 112 KG