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

Model Number	1804400-33
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 4.0x33mm rx xience skypoint drug eluting stent system (des) was advanced to the target lesion however when attempting to inflate the device contrast was noted to be exiting from the luer lock.It appeared the luer threads were deformed and could not connect correctly to the indeflator.The skypoint was replaced with another xience and the procedure was completed.There were no adverse patient effects and no reported clinical delay.
Additional Manufacturer Narrative
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 and functional testing were performed on the returned device.The reported irregular appearance, leak and connection issue was confirmed.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 was unable to determine a conclusive cause for the reported quality problem related to irregular appearance of the inflation hub.The device was returned and the irregular appearance was confirmed through the observed excess of plastic like material in the inner diameter of the sidearm.A portion of the unknown material was sent for sem analysis and was identified to resemble polycarbonate resin which is not used in the manufacturing of the xience skypoint product; therefore, it is unlikely the contamination occurred during manufacture of the device.It is possible that accessory devices used during the reported attempt to inflate the xience skypoint delivery system transferred the material; however, this cannot be confirmed.The reported leak and loose/intermittent connection issues appear to be related to the excess material in the inflation port blocking the inflation device from connecting securely.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.
Event or Problem Description
It was reported that a 4.0x33mm rx xience skypoint drug eluting stent system (des) was advanced to the target lesion however when attempting to inflate the device contrast was noted to be exiting from the luer lock.It appeared the luer threads were deformed and could not connect correctly to the indeflator.The skypoint was replaced with another xience and the procedure was completed.There were no adverse patient effects and no reported clinical delay.

• 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: 20281206
• Report Number: 2024168-2024-11199
• Device Sequence Number: 12626072
• Product Code: NIQ
• UDI-Device Identifier: 08717648233517
• UDI-Public: (01)08717648233517(17)261018(10)3102541
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/01/2025

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: 1804400-33
• Device Catalogue Number: 1804400-33
• Device Lot Number: 3102541
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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 Age: 69 YR
• Patient Sex: Unknown