MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1804350-38
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	03/15/2024
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 to treat a lesion in the right radial artery.The 3.5x38mm xience skypoint stent delivery system was negatively prepared and failed to follow preparation procedure per instructions for use (ifu).There was no resistance during removal of the protective sheath and there was no force applied.Upon inserting the sds onto the 6french (f) guiding catheter, it was noted that the stent was missing.The stent was found and noted to be half in and half out of the protective sheath.Another xience skypoint stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The 3.5x38mm xience skypoint stent delivery system was negatively prepared and failed to follow preparation procedure per instructions for use (ifu).It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use, states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.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.Stent dislodgement prior to use 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 inadvertent mishandling during sheath/stylet removal and/or preparation of the device may have contributed 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.D4 correction: lot number updated from 3091941 to 3081741.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19037911
• Report Number: 2024168-2024-04227
• Device Sequence Number: 15500818
• Product Code: NIQ
• UDI-Device Identifier: 08717648233449
• UDI-Public: (01)08717648233449(17)260809(10)3081741
• 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): 05/22/2024

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: 08/09/2026
• Device Catalogue Number: 1804350-38
• Device Lot Number: 3081741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDE CATHETER
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 105 KG