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

Model Number	1804250-12
Medical Device Problem Codes	Difficult to Remove (1528); 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	01/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficulty to advance and difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.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 reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.It was reported that the procedure was to treat the bifurcation of the left anterior descending (lad) and diagonal coronary arteries.A 2.5x12 mm xience skypoint stent delivery system (sds) was in the diagonal artery prior to deployment and they were trying to keep the plaque from shifting from the diagonal to the lad.The 3.0x15 mm nc trek neo balloon dilatation catheter (bdc) could not advance and got snagged on the undeployed stent in the diagonal and separated at the distal shaft.Everything was able to be removed on the guide wire despite difficulty and some force was used.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use, states: applying excessive force to the delivery system can potentially result in loss of 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.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.D4: corrected lot # from 4012241 to 4110441.D4: corrected expiration date from 1/15/2027 to 10/24/2027.D4: corrected primary udi number from (b)(4).To (b)(4).H4: corrected mfg date from 1/16/2024 to 10/25/2024.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.H6: medical device problem code 2017- excessive force.
Event or Problem Description
It was reported that the procedure was to treat the bifurcation of the left anterior descending (lad) and diagonal coronary arteries.A 2.5x12 mm xience skypoint stent delivery system (sds) was in the diagonal artery prior to deployment and they were trying to keep the plaque from shifting from the diagonal to the lad.The 3.0x15 mm nc trek neo balloon dilatation catheter (bdc) could not advance and got snagged on the undeployed stent in the diagonal and separated at the distal shaft.Everything was able to be removed on the guide wire despite difficulty and some force was used.The procedure was completed with a new stent and balloon.There were no adverse patient effects and there was no clinically significant delay 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: 21425649
• Report Number: 2024168-2025-01927
• Device Sequence Number: 12809217
• Product Code: NIQ
• UDI-Device Identifier: 08717648233067
• UDI-Public: (01)08717648233067(17)271024(10)4110441
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 1804250-12
• Device Catalogue Number: 1804250-12
• Device Lot Number: 4110441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.0X15 MM NC TREK NEO BALLOON
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White