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

Model Number	1804250-18
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the stent delivery system (sds) interacted with the patient¿s heavily calcified, moderately tortuous, and 90% stenosed lesion during advancement, resulting in the reported difficult to advance.It is likely that the interaction between the sds and lesion impacted the integrity of the device, resulting in the reported material rupture and subsequent activation failure.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.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous proximal left circumflex artery that is 90% stenosed.Ablations were performed a 2.25x18mm non-abbott balloon was used to pre-dilate the lesion.The 2.5x18mm xience skypoint stent delivery system was advanced; however, resistance was felt anatomy.When attempting to deploy the stent the balloon on the delivery system ruptured at 6 atmospheres.The stent was not deployed and was removed with the delivery system.A new 2.25x10mm non-abbott balloon was used to inflate the lesion a 2.25x18mm xience skypoint was implanted.A 2.5x10mm balloon was used to perform post-dilatation several times.There was no adverse patient effect and 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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20014713
• Report Number: 2024168-2024-09724
• Device Sequence Number: 19919344
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: (01)08717648233081(17)250517(10)205134A
• 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
• Report Date (Section B): 08/19/2024

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: 05/17/2025
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 205134A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2022
• 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