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

Model Number	1804400-12
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
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.H6: medical device problem code 2017- incorrect prep.
Event or Problem Description
It was reported that the procedure was to treat the proximal right coronary artery with heavy calcification, moderate tortuosity and 90% stenosis.The 4.0x12 mm xience skypoint stent delivery system (sds) balloon was was advanced with resistance noted with the anatomy and was prepped inside the anatomy.The sds balloon was inflated once for deployment; however, the balloon ruptured as the balloon stopped increasing during inflation.The stent was removed on the balloon of the device.A new xience skypoint sds was used to continue the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
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 received, the investigation determined that the reported difficulty to advance appears to be related to operational context.Based on the information provided, a definitive cause for the reported material rupture and activation failure could not be determined.It was reported that the procedure was to treat the proximal right coronary artery with heavy calcification, moderate tortuosity and 90% stenosis.The 4.0x12 mm xience skypoint stent delivery system (sds) balloon was advanced with resistance noted with the anatomy and was prepped inside the anatomy.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: while introducing the delivery system into the vessel, do not induce negative pressure on the delivery system.This may cause dislodgement of the stent from the balloon.In this case, it does not appear the instruction for use (ifu) deviation related to incorrect stent preparation contributed to the reported difficulties; therefore, a letter will not be requested.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.

• 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: 20473201
• Report Number: 2024168-2024-12254
• Device Sequence Number: 7245632
• Product Code: NIQ
• UDI-Device Identifier: 08717648233463
• UDI-Public: (01)08717648233463(17)260330(10)3040541
• 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): 10/25/2024

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 Expiration Date: 03/30/2026
• Device Model Number: 1804400-12
• Device Catalogue Number: 1804400-12
• Device Lot Number: 3040541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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
• Patient Sex: Unknown