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

Model Number	1804400-48
Medical Device Problem Codes	Off-Label Use (1494); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
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 deflation problem (failure to deflate) could not be determined; however, the subsequent unexpected medical intervention appears to be related to circumstances of the procedure.Factors that may contribute to deflation problems (failure to deflate) include, but are not limited to, deflation technique, contrast concentration, contamination in the inflation lumen, damage to the guide wire and/or inflation lumen.Additional follow up with the account reported that they were unsure how many atmospheres the device was inflated to during deployment.In this case, it is possible that procedural/deflation technique may have contributed to the reported failure to deflate (deflation problem); however, based on the information provided and without the device to examine, this cannot be confirmed.A guide wire (gw) was used to puncture the balloon.The stent was noted to be fully opposed to the vessel was and successfully implanted.In addition, it was reported that the procedure was to treat a lesion in the right tibial perineal artery.The xience skypoint instructions for use (ifu) specifies: the xience skypoint stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length equal or less than 32 mm) with reference vessel diameters of greater than or equal to 2.25 mm and equal or less than 4.25 mm.In addition, the xience skypoint stent system is indicated for treating de novo chronic total coronary occlusions.It is unknown if the instructions for use (ifu) deviation contributed to the reported event.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.H6 medical device problem code: 1494 - indication for use.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right tibial perineal artery with calcification and tortuosity.The 4x48mm xience skypoint stent was advanced to the target lesion and the stent was implanted; however, the stent balloon fail to deflate.Therefore, an unspecified guide wire (gw) was used to puncture the balloon to remove the delivery system, ending the procedure.The stent was noted to be fully opposed to the vessel was and successfully implanted.There was no adverse patient sequela 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: 22470593
• Report Number: 2024168-2025-07095
• Device Sequence Number: 4234554
• Product Code: NIQ
• UDI-Device Identifier: 08717648231315
• UDI-Public: (01)08717648231315(17)260115(10)5012141
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2026
• Device Model Number: 1804400-48
• Device Catalogue Number: 1804400-48
• Device Lot Number: 5012141
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown