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

Model Number	1804300-23
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); 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	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with 99% stenosis.The 3.0x23 mm xience skypoint stent was deployed and the delivery system was removed.Subsequently, in order to perform kissing balloon technique (kbt), a wire was advanced through the stent into the side branch and the xience skypoint delivery system balloon was rewrapped and re-inserted into the xience skypoint stent but not inflated.The balloon could not be re-advanced and became deformed into a ball shape and could not be fully inserted into the guiding catheter.A non-abbott balloon was unable to advance into the side branch for kissing technique, so the delivery system was then attempted to be removed but there was resistance and the balloon separated after force was applied.Reportedly, a trapping balloon was used to retrieve the separated balloon.The guiding catheter, guidewire and trapping balloon were removed together as a unit.Kbt was performed with new balloons.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
H6 medical device problem code: 2017 - excessive force.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance and difficult to remove could not be tested due to the condition of the returned device.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, the subsequent unexpected medical intervention appears to be related to the operational context of the procedure.Potential causes for a material separation include, but are not limited to, inadvertent mishandling during unpackaging, during preparation or use of the device, interaction with the anatomy and/or accessory devices.Factors which may contribute to difficulty advancing the device in the guiding catheter include, but are not limited to, damage to the stent, damage to the guiding catheter, guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).Factors that can contribute to difficult to remove include, but are not limited to, kinks, bends, procedural technique, insufficient support, patient disease state, or interactions with other devices.In this case, it is possible that the device interacted with accessory devices (guide catheter/guide wire) during advancement, causing the reported difficult to advance and observed bunched balloon.Further interaction with the guide catheter during retraction of the device, as resistance was noted, may have contributed to the reported difficult to remove and observed stretched, torn and bunched inner member as force was applied, ultimately causing the reported material separation from the balloon and observed material separation to the inner member; however, this cannot be confirmed.Reportedly, a trapping balloon was used to retrieve the separated balloon.The guiding catheter, guidewire and trapping balloon were removed together as a unit.In addition, it was reported that a non-abbott balloon was unable to advance into the side branch for kissing technique.The delivery system was then attempted to be removed, but there was resistance, and the balloon separated after force was applied.It should be noted that the xience skypoint, electronic instructions for use (eifu) states: if during withdrawal of the catheter, resistance is encountered, re-inflate the balloon up to nominal pressure, deflate and change pressure to neutral.Applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.It is unknown if the ifu deviations directly caused or contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.E1: corrected initial reporter establishment name from to (b)(6).E1: corrected address 1 from (b)(6).E1: corrected city from (b)(6).
Event or Problem Description
Subsequent to the initially filed report it should be noted that after the balloon could not be readvanced, it was balled up and could not be pulled into the guiding catheter for removal.

• 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: 23184675
• Report Number: 2024168-2025-10483
• Device Sequence Number: 9115187
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: (01)08717648233258(17)260201(10)3020841
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 02/01/2026
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 3020841
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown