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

Model Number	1804225-12
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
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.The additional device referenced in b5 and d10 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat lesions in the left anterior descending (lad) and first diagonal arteries.After pre-dilatation with a non-abbott balloon, the 2.5x15mm nc trek neo balloon dilatation catheter (bdc) was advanced to the bifurcation of the lad; then the non-abbott balloon was removed.A 2.25x12mm xience skypoint stent delivery system (sds) was then attempted to be advance to the first diagonal; however, the sds became stuck in the guide catheter.Therefore, the guide wire, sds and bdc were removed with resistance.There was no adverse patient effect and no clinically significant delay reported in the procedure.
Additional Manufacturer Narrative
Visual inspection, functional testing, and dimensional analysis were performed on the returned device.The reported difficulty advancing and removing the device could not be confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported difficulties could not be determined.In this case, it is likely that the xience skypoint sds interacted with the nc trek neo bdc during advancement/manipulation due to the reduced clearance in the guiding catheter and became entangled with one another, resulting in the reported difficulties advancing and removing the devices; however, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20888929
• Report Number: 2024168-2024-14435
• Device Sequence Number: 8675932
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: (01)08717648232985(17)270611(10)4061441
• Combination Product (Y/N): Y
• 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): 01/20/2025

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: 1804225-12
• Device Catalogue Number: 1804225-12
• Device Lot Number: 4061441
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/18/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.25X12MM XIENCE SKYPOINT STENT; 2.5X15MM NC TREK NEO BALLOON; 2.5X15MM NC TREK NEO BALLOON; 6FR INTRODUCER; 6FR INTRODUCER; 6FR XB 3.0 GUIDE CATHETER; 6FR XB 3.0 GUIDE CATHETER; RUNTHROUGH GUIDE WIRE; RUNTHROUGH GUIDE WIRE
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Hispanic
• Patient Race: White