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

Model Number	1804400-18
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
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 the right coronary artery with mild calcification, moderate tortuosity and 75% stenosis.After intravascular ultrasound (ivus), the 4.0x18 mm xience skypoint stent delivery system (sds) was advanced to the lesion but it could not cross due to the anatomy.The device was removed in order to perform pre-dilation and it was found that the balloon was ruptured [torn], able to be seen visually.The device was not used and a 3.5x18 mm xience skypoint was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported split, cut or torn material was not confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.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 and analysis of the returned device, a definitive cause for the reported difficulties could not be determined; however, factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Potential factors that may contribute to split, cut or torn material include, but are not limited to, interaction with accessory devices, anatomical conditions, mishandling during manufacturing, during receiving/storage at the account, and/or during removal from packaging, preparation of the device and/or protective sheath/stylet removal.In this case, it is possible the device may have interacted with the mildly calcified, moderately tortuous, 75% stenosed lesion during advancement, causing the reported failure to advance and observed material deformation (bent and lifted stent struts); however, based on the information provided by the account, 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.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
Returned device analysis identified the stent was dislodged.There was no rupture or tear as reported but the account confirmed the correct device was received.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: 23394442
• Report Number: 2024168-2025-11230
• Device Sequence Number: 10015248
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: (01)08717648233487(17)270611(10)4062041
• 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,Followup
• Report Date (Section B): 12/10/2025

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: 1804400-18
• Device Catalogue Number: 1804400-18
• Device Lot Number: 4062041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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