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

Model Number	1804400-23
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
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 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 anatomical morphology, patient disease state, interaction with previously placed stents or accumulation of blood or contrast.In this case, it is possible that the device may have interacted with the heavily calcified, moderately tortuous, 90% stenosed right coronary artery (rca) during advancement, as resistance was noted, causing the reported difficulty to advance.Further interaction with the challenging anatomy during positioning and inflation of the device may have contributed to the reported material rupture; however, without the device to examine, 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 was to treat a 90% stenosed de novo lesion in the right coronary artery (rca) with heavy calcification and moderate tortuosity.After rotablation and pre-dilatation, the 4x23mm xience skypoint stent delivery system(sds) was advanced the target lesion with resistance due to the anatomy.At the target lesion the sds balloon was inflated to 6 atmospheres (atm); however, the balloon ruptured.Therefore, the sds with the stent were removed from the patient.Additional balloon dilatation, stent implantation and post-dilatation were performed to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.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: 22235283
• Report Number: 2024168-2025-06224
• Device Sequence Number: 8176530
• Product Code: NIQ
• UDI-Device Identifier: 08717648233494
• UDI-Public: (01)08717648233494(17)270613(10)4061841
• 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): 06/17/2025

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 Model Number: 1804400-23
• Device Catalogue Number: 1804400-23
• Device Lot Number: 4061841
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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
• Patient Sex: Unknown