MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804300-08
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis/Thrombus (4440)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a research article, identifying the xience skypoint 3mm×8mm des and the dragonfly opstar imaging catheter as follows: the purpose of this study is to show an ultrathin-strut cs can prevent the protrusion and progression of underlying calcified nodules.The patient presented with angina due to severe stenosis with calcified nodules in the right coronary artery.Percutaneous coronary intervention (pci) was performed using a non-abbott laser coronary atherectomy device, causing a perforation.A non-abbott ultrathin-strut cs was implanted to treat the perforation.Due to protrusions in the proximal edge of the implanted, a ultrathin-strut cs stent, and a 3.0mm×8mm xience skypoint drug eluting stent were implanted to correct the ultrathin-strut cs issue, which resulted in sufficient angiographic results.Intravascular ultrasound showed adequate stent expansion.Dual-antiplatelet therapy with aspirin and prasugrel was initiated before the pci and continued there-after.Six months post pci, the patient presented with onset angina at rest.Angiography revealed a total occlusion of the ultrathin-strut cs.This is late stent thrombosis.After thrombus aspiration and pre-dilatation, optical coherence tomography (oct) was performed with a dragonfly opstar imaging catheter without issue.Oct revealed the ultrathin-strut cs, were fully covered with neointima and thrombus with hyperplasia.Half of xience skypoint struts were [uncovered], and some struts were malposed.It is speculated that the cause of the current late st was dispersion of the thrombi formed at the uncovered and malposed sites in the xience skypoint des, into a severe stenosis caused by neointimal hyperplasia in the ultrathin-strut cs, resulting in total occlusion.Oct within the covered stent showed possible acute thrombus formation over the thrombus in the ultrathin-strut cs.Final angiography revealed adequate expansion and coronary flow.Chest pain improved after the pci.Three months after discharge, the patient had no further episodes of chest pain.In conclusion, if an ultrathin-strut cs can prevent the protrusion and progression of underlying calcified nodules, introduction of an ultrathin-strut cs for lesions with calcified nodules should be carefully considered.Please see attached article "late stent thrombosis six months after ultrathin-strut covered stent implantation in lesion with calcified nodule" for additional information.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of event is estimated.D4: the udi number is not known as the part and lot number were not provided.Literature attachment: article titled; "late stent thrombosis six months after ultrathin-strut covered stent implantation in lesion with calcified nodule".
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.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.The reported patient effects of angina and thrombosis are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B3: corrected date of event from 4/15/2024 to 12/8/2022.D4: corrected model, catalog number from unk xience skypoint to 1804300-08.D4: corrected lot number from unknown to 0072241.
Event or Problem Description
Subsequent to the initial filed report, the following information was provided: the xience skypoint stent was implanted on (b)(6) 2022.The date the patient returned to the hospital with sudden onset angina is (b)(6) 2022.Percutaneous coronary intervention (pci) was performed as treatment.The dragonfly device was an optis and not an opstar.No additional information was provided.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 21462611
• Report Number: 2024168-2025-02071
• Device Sequence Number: 8840791
• Product Code: NIQ
• UDI-Device Identifier: 08717648233210
• UDI-Public: (01)08717648233210(17)230811(10)0072241
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: 1804300-08
• Device Catalogue Number: 1804300-08
• Device Lot Number: 0072241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female