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

Model Number	1804275-23
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - medical device problem code 2017 clarifier: incorrect prep manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery (rca).The 2.75 x 23mm rx xience skypoint drug eluting stent (des) was prepped prior to removing the protective sheath.The sds was advanced to the lesion for deployment; however, the stent was noted to be dislodged and located at the radial access site of the copilot.The des with the dislodged stent was simply removed and replaced with another xience des and the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned stent implant.The reported stent dislodgement was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no similar complaints from this lot.It was reported the 2.75 x 23mm rx xience skypoint stent delivery system was prepared for use prior to removing the protective sheath.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: prior to preparation of the device, remove the product mandrel and protective stent sheath by grasping the catheter just proximal to the stent (at the proximal balloon bond site), and with the other hand, grasp the stent protector and gently move distally.It is unknown if the ifu deviation directly caused or contributed to the reported event.A conclusive cause for the reported stent dislodgement could not be determined; however, stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with accessory devices.In this case, it is possible that the device may have interacted with the radial access site of the copilot, causing the observed material deformation, and ultimately contributing to the reported stent dislodgement; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 19906376
• Report Number: 2024168-2024-09191
• Device Sequence Number: 12962626
• Product Code: NIQ
• UDI-Device Identifier: 08717648233173
• UDI-Public: (01)08717648233173(17)270116(10)4012341
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 08/27/2024

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 Model Number: 1804275-23
• Device Catalogue Number: 1804275-23
• Device Lot Number: 4012341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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: ACCESSORY: COPILOT
• Patient Sex: Unknown