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

Model Number	1804350-33
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
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.A conclusive cause for the reported device damaged by another device could not be determined; however, the subsequent surgical intervention appears to be related to the operational context of the procedure.Device damaged by another device may be attributed to several factors including, but are not limited to, lesion inadequately predilated, lesion selection (not treating the distal lesion first), interaction between accessory devices or previously implanted stents.In this case, it is possible that the guide wire may have interacted with the previously implanted stent, which was explanted and became located in the patient's right brachial artery, causing the reported device damaged by another device; however, this cannot be confirmed.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.
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, heavily calcified, heavily tortuous left anterior descending coronary artery.The 3.50 x 33 mm xience skypoint drug-eluting stent (des) was implanted.Upon removal of an unspecified guide wire in a secondary branch, the des was explanted and located in the patient's right brachial artery.A 3.5 x 38 mm xience des was implanted in the lad to replace the explanted stent.The patient was currently admitted and heparinized overnight.The following day ((b)(6) 2026), the patient underwent a cutdown and the 3.50 x 33 mm des was successfully removed.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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 25410955
• Report Number: 2024168-2026-02292
• Device Sequence Number: 21215774
• Product Code: NIQ
• UDI-Device Identifier: 08717648233432
• UDI-Public: (01)08717648233432(17)281204(10)5121041
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1804350-33
• Device Catalogue Number: 1804350-33
• Device Lot Number: 5121041
• 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: 05/26/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 143 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American