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

Model Number	1804350-33
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and tortuous lesion in the left anterior descending (lad).Following extensive pre-dilatation with a 2.75x15mm and 3.0x15mm non-abbott balloon catheters, a 3.50x33mm xience skypoint drug-eluting stent (des) was attempted to be advanced to the lesion; however, failed to cross due to the calcification.Therefore, the des was removed and the same des was loaded onto a non-abbott guide extension catheter and readvanced to the lesion through resistance with the anatomy.The des was able to cross the lesion; however, during a deployment attempt the balloon was noted to rupture at 6 atms.The stent remained on the balloon; therefore, the entire system was removed from the anatomy.The procedure was completed with the use of additional dilatation, and the implantation of a 3.25x18mm and 3.5x18mm xience skypoint.There were no adverse patient effects nor clinical delay.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 provided, a definitive cause for the reported difficulties could not be determined; however, factors that may contribute to material ruptures include, but are not limited to, material damage, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.Difficult to advance/position may be attributed to several factors including, but are not limited to, product placement technique, guiding catheter support, anatomical conditions, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, interaction with accessory devices, damage to the catheter, patient disease state, interaction with previously placed stents or accumulation of blood or contrast.In this case, it is possible the device may have interacted with the moderately calcified, moderately tortuous, 90% stenosed lesion during advancement, as resistance was noted, causing the reported difficult to advance.Further manipulation of the device including interaction with the challenging anatomy may have damaged the device, contributing to the reported material rupture; however, without the device to examine, this cannot be confirmed.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.It was reported that the xience skypoint was advanced to the lesion and was removed, then the same device was reinserted.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodge during retraction back into the guiding catheter.It is unknown if the ifu deviation directly caused or contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2017: re-insertion.

• 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: 22668479
• Report Number: 2024168-2025-07899
• Device Sequence Number: 18044285
• Product Code: NIQ
• UDI-Device Identifier: 08717648233432
• UDI-Public: (01)08717648233432(17)260913(10)3092141
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2026
• Device Model Number: 1804350-33
• Device Catalogue Number: 1804350-33
• Device Lot Number: 3092141
• 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: 07/11/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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: GUIDE EXTENSION CATHETER: GUIDE PLUS.
• Patient Sex: Unknown