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

Model Number	1804275-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Thrombosis/Thrombus (4440)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id (b)(6).It was reported that the left heart catheterization procedure was performed to treat a target lesion, with severe 70 to 75% stenosis, in the left anterior descending (lad) coronary artery.Circumferential 360 degree calcification was confirmed by optical coherence tomography.Intravenous lithotripsy (ivl) was performed with the abbott ivl device.There was very good result with some plaque shift into the distal diagonal branch, but timi 3 flow was still good into this diagonal.The 2.75 x 15 mm xience skypoint stent was implanted in the lad, resulting in very good angiographic results.The case moved on to the small diagonal branch, but the balloon dilatation catheter was unable to cross.At this time, the lad stent appeared to be developing thrombus.A second 3.0 x18 mm xience skypoint stent was implanted in the first stent, resulting in timi 3 flow.There was no residual stenosis; however, the small diagonal branch was lost (occluded).At this time, the patient reported chest pain.Thrombus was again noted in the lad stent.A third 3.0 x 23 mm xience skypoint stent was placed, successfully treating the thrombosed stent.The patient was doing well and the procedure was completed successfully.Angiomax (bivalirudin) is an anticoagulant, which is used as the standard of care for patients to be anticoagulated during stent procedures.It is believed that, during the procedure, the intravenous line (iv) containing the angiomax was intermittently compressed by the blood pressure cuff, which was placed over it.A new iv was started after it was noted that the second stent had also thrombosed.No additional information was provided.
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.The reported patient effects of thrombosis and angina are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use (ifu) 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; therefore, no product-related corrective action will be implemented in this case.The additional device referenced in b5 is filed under a separate medwatch report number.

• 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22651734
• Report Number: 2024168-2025-07881
• Device Sequence Number: 8678377
• Product Code: NIQ
• UDI-Device Identifier: 08717648233159
• UDI-Public: (01)08717648233159(17)270114(10)4011841
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1804275-15
• Device Catalogue Number: 1804275-15
• Device Lot Number: 4011841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White