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

Model Number	1804350-23
Medical Device Problem Codes	Stretched (1601); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
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
It was reported that the procedure was to treat a lesion in the proximal left circumflex (plcx) artery with heavy calcification and heavy tortuosity.The 3.5x23mm xience skypoint stent was advance on a non-abbott guide wire (gw) to the target lesion with resistance due to the anatomy.The xience skypoint stent was implanted at the target lesion; however, when the non-abbott gw was attempted to be removed, the gw was noted to be stuck with the implanted stent and the stent became elongated.Therefore, a snare was used to remove the stent and gw.The procedure ended and the procedure was noted to have taken 4 hours due to the stuck gw.There was no adverse patient sequela and a delay was reported in the procedure.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.Based on the information received, the investigation determined that the reported difficulties and treatment appears to be related to operational context of the procedure.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.H10: user facility medwatch report number not provided.
Event or Problem Description
Subsequent to the initially filed report, the following additional information was received: user facility medwatch report received that states "wire was inserted into the circumflex lesion.Ivus inserted into the circumflex lesion, ivus inserted but wouldn't cross.Physician tried ballooning vessel open.Ivus then showed heavy calcification lithotripsy performed.Stent was then inverted but would not advance.Guide catheter inserted to help.Stent was then successfully placed when trying to remove stent and balloon and wire.It got stuck in the stent struts.This caused elongation of the stent.A balloon and different guide catheter and balloon were utilized to try and free wired/stent.It was at this point; the guide wire tip broke off.Ct surgery consulted for additional ideas/help.Physician attempted to snare wire.After upsizing snare, physician was able to snare the broke off wire.Physician was then able to snare the elongated stent for removal.No harm came to the patient.Remained hemodynamically stable.The patient was admitted to sicu for observation and was discharged the next day." no additional information was provided.
Additional Manufacturer Narrative
Corrected b5, h10.Medwatch report attached.
Event or Problem Description
Subsequent to the previous final report filed, an additional medwatch form was received, medwatch number is mw5172946, stating "wire was inserted into the circumflex lesion.Iv us inserted but would not cross.Physician tried ballooning vessel open.Is us then showed heavy calcification.Lithotripsy performed.Stent was then inserted but would not advance.Guide catheter inserted to help.Stent was then successfully placed.When trying to remove stent balloon and wire, it got stuck in the stent struts.Intervention to remove was successful.Patient harm avoided." 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: 22440041
• Report Number: 2024168-2025-06995
• Device Sequence Number: 11948457
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: (01)08717648233418(17)280217(10)5022641
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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: 1804350-23
• Device Catalogue Number: 1804350-23
• Device Lot Number: 5022641
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 07/31/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/29/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: GUIDEWIRE: RUNTHROUGH (TERUMO).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White