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

Model Number	1804350-23
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that several attempts to pass the 3.5x23 mm xience skypoint stent delivery system (sds) through the non-abbott guide catheter extension were made during the percutaneous coronary intervention in the right coronary artery.After multiple unsuccessful attempts, the physician removed the undeployed sds from the body when it was noted that the stent was no longer on the sds.After the undeployed stent was not found in the patient under fluoroscopy, the non-abbott guide catheter extension was removed and the undeployed stent was found inside the tip of the non-abbott guide catheter extension.The stent was removed from the non-abbott guide catheter extension and was found to have a small fracture on the stent itself.The procedure was completed with another abbott stent.No patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the procedure was completed after this failure to cross the lesion.No other attempt was made to stent the predilated, calcified lesion.Additional information was received which indicated that this complaint is a duplicate of cn-337875, previously filed under mfr# [2024168-2026-00013].The complaint was confirmed to be a duplicate based on the following information that matched: account number, procedure date, device lot number, physician name, target vessel, event details.No additional information was provided.
Additional Manufacturer Narrative
Correction: this event, (b)(4) has been identified as a duplicate of (b)(4) and the investigation will be completed under (b)(4).

• 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: 23922646
• Report Number: 2024168-2025-12276
• Device Sequence Number: 21098375
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: (01)08717648233418(17)280625(10)5063041
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 02/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1804350-23
• Device Catalogue Number: 1804350-23
• Device Lot Number: 5063041
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 70 KG